Page last updated: 2024-12-10

icodextrin

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Description

Icodextrin: A glucan that is structurally related to maltodextrin, with more than 85% of its molecules having molecular weights between 1640 and 45 000 Daltons (Da), and a weight-average molecular weight of about 20 000 Da; it is used in dialysis fluids as an alternative to glucose-based solutions, and to reduce adhesions after gynecological or abdominal surgery. It has also been used as a vehicle for drugs given via the peritoneal cavity. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID4471484
SCHEMBL ID21797158
MeSH IDM0275943

Synonyms (6)

Synonym
icodextrin
FT-0626783
BCP19030
SCHEMBL21797158
DTXSID70864156
hexopyranosyl-(1->4)-[hexopyranosyl-(1->6)]hexopyranosyl-(1->4)hexopyranose

Research Excerpts

Overview

Icodextrin (IDX) is an antiadhesive polymer that can be used as a carrier solution for intraperitoneal (IP) delivery of chemotherapeutic drugs. It is a colloidal osmotic agent used in peritoneal dialysis (PD) solutions to augment ultrafiltration and waste removal.

ExcerptReferenceRelevance
"Icodextrin is a high molecular weight, starch-derived glucose polymer that is used as an osmotic agent in peritoneal dialysis (PD) to promote ultrafiltration. "( Icodextrin use for peritoneal dialysis in Australia: A cohort study using Australia and New Zealand Dialysis and Transplant Registry.
Badve, S; Borlace, M; Boudville, N; Clayton, P; Guddattu, V; Johnson, DW; Rangaswamy, D; Sud, K; Webster, AC, 2020
)
3.44
"Icodextrin (IDX) is an antiadhesive polymer that can be used as a carrier solution for intraperitoneal (IP) delivery of chemotherapeutic drugs."( Experimental evaluation of icodextrin delivery as pressurized aerosol (PIPAC): Antiadhesive and cytotoxic effects.
Keck, HS; Königsrainer, A; Nadiradze, G; Reymond, MA; Shegokar, R; Weinreich, FJ, 2021
)
2.36
"Icodextrin is a starch-derived glucose polymer used in peritoneal dialysis dialysate to treat volume overload by increasing ultrafiltration in patients with end-stage renal disease. "( Eosinophilia in a peritoneal dialysis patient: Answers.
Becker-Cohen, R; Ben-Shalom, E; Frishberg, Y; Rinat, C; Tzvi-Behr, S, 2018
)
1.92
"Icodextrin is a glucose polymer derived from starch that is used as an osmotic agent in peritoneal dialysis. "( [Icodextrin: What arguments for and against its use as an osmotic agent in peritoneal dialysis].
Flechon-Meibody, F; Goffin, É; Savenkoff, B, 2018
)
2.83
"Icodextrin is a polymer that is already in clinical use because it is slowly eliminated from the peritoneal cavity."( Synthesis and Activity of a Novel Autotaxin Inhibitor-Icodextrin Conjugate.
Allin, SM; Bulman Page, PC; Edwards, MG; Elsegood, MRJ; Fisher, N; Hemming, R; Jones, SM; King-Underwood, J; Mckenzie, MJ; Richardson, A; Wallis, JD, 2018
)
1.45
"Icodextrin is a starch-derived, water soluble glucose polymer, which is used as an alternative to glucose in order to enhance dialytic fluid removal in peritoneal dialysis patients. "( Icodextrin-associated generalized exfoliative skin rash in a CAPD patient: a case-report.
Demirtzi, P; Georgianos, PI; Kalathas, T; Liakopoulos, V; Vaios, V; Zebekakis, PE, 2018
)
3.37
"Icodextrin is a colloidal osmotic agent used in peritoneal dialysis (PD) solutions to augment ultrafiltration and waste removal."( Avoidable iatrogenic hypoglycemia in patients on peritoneal dialysis: the risks of nonspecific glucose monitoring devices and drug-device interaction.
Firanek, CA; Jacob, DT; Sloand, JA, 2014
)
1.12
"Icodextrin is a peritoneal dialysis solution that is commonly used to increase ultrafiltration during the long dwell. "( Practical considerations when prescribing icodextrin: a narrative review.
Harel, Z; Perl, J; Silver, SA, 2014
)
2.11
"4% icodextrin is a fluid that can be instilled laparoscopically to prevent adhesion formation. "( Postoperative Urinary Retention With Gross Vulvar Edema After Use of 4% Icodextrin.
Reed, B; Robinson, R, 2015
)
1.27
"Icodextrin is a solution of glucose polymers developed to provide sustained ultrafiltration over an extended dwell. "( Impact of fill volume on ultrafiltration with icodextrin in children on chronic peritoneal dialysis.
Ackerman, S; Banh, TM; Harvey, EA; Licht, C; Piva, E; Rousso, S, 2016
)
2.14
"Icodextrin is a glucose polymer derived by hydrolysis of cornstarch. "( Icodextrin does not impact infectious and culture-negative peritonitis rates in peritoneal dialysis patients: a 2-year multicentre, comparative, prospective cohort study.
Divino Filho, JC; Marrón, B; Michel, C; Remón, C; Rodríguez-Carmona, A; van der Heyden, S; Vonesh, E; Vychytil, A; Williams, P, 2008
)
3.23
"Icodextrin is a glucose polymer that can be substituted for dextrose with avoidance of some of the glucose-dependant effects."( Icodextrin: an alternative peritoneal dialysis fluid.
Chhabra, D; Nash, K, 2008
)
2.51
"Icodextrin is an effective tool not only for increasing adequacy, but also for removing more sodium in both modalities."( Sodium removal in peritoneal dialysis: the role of icodextrin and peritoneal dialysis modalities.
Dousdampanis, P; Fourtounas, C; Hardalias, A; Papachristopoulos, B; Savidaki, E; Vlachojannis, JG, 2008
)
1.32
"Icodextrin is a glucose polymer used to maintain an osmotic gradient in peritoneal dialysis. "( The danger of using inappropriate point-of-care glucose meters in patients on icodextrin dialysis.
Chua, EL; Perera, NJ; Stewart, PM; Twigg, SM; Williams, PF; Yue, DK, 2011
)
2.04
"Icodextrin is an important source of interference that sometimes even experienced professionals are unaware of and which leads to clinically significant errors in insulin dose adjustment."( The danger of using inappropriate point-of-care glucose meters in patients on icodextrin dialysis.
Chua, EL; Perera, NJ; Stewart, PM; Twigg, SM; Williams, PF; Yue, DK, 2011
)
1.32
"Icodextrin is a glucose polymer osmotic agent used to provide sustained ultrafiltration during long peritoneal dialysis (PD) dwells. "( Pharmacokinetics of icodextrin in peritoneal dialysis patients.
Gehr, T; Hamburger, R; Kucharski, A; Martis, L; Moberly, JB; Mujais, S; Ogrinc, F; Reynolds, R; Sprague, S; Wolfson, M, 2002
)
2.08
"Icodextrin (IC) is an osmotic agent that produces sustained ultrafiltration (UF) during long dwell time periods in peritoneal dialysis patients. "( [Use of icodextrin for diurnal exchange in patients undergoing automatic peritoneal dialysis. Comparison with glucose solutions].
Bajo, MA; Castro, MJ; Costero, O; del Peso, G; Gil, F; Hevia, C; Jiménez, C; Olea, T; Selgas, R, 2002
)
2.19
"Icodextrin is a glucose polymer osmotic agent used to achieve sustained ultrafiltration during long peritoneal dialysis dwells. "( A rapid assay for icodextrin determination in plasma and dialysate.
Gass, J; Hughes, G; Kunzler, J; Martis, L; Moberly, JB; Mongoven, JW; Patel, H; Shockley, TR; Wang, R, 2002
)
2.09
"Icodextrin functions as a competitive inhibitor in the assay for amylase activity, as predicted by the structural similarities between icodextrin and the amylase assay substrate."( Kinetic analysis of icodextrin interference with serum amylase assays.
Leesch, V; Martis, L; Moberly, JB; Turner, P; Wang, R, 2002
)
1.36
"Icodextrin is a new peritoneal dialysis fluid, with maltose polymers providing the osmotic drive, that may extend time on peritoneal dialysis in situations in which use of conventional glucose-based peritoneal dialysis fluid (Dianeal) has led to loss of ultrafiltration. "( Relapsing culture-negative peritonitis in peritoneal dialysis patients exposed to icodextrin solution.
Alexander, G; Cohen, S; Cooney, K; Goldsmith, DJ; MacGinley, R, 2002
)
1.98
"Icodextrin is an 7.5% isoosmotic solution of the glucose polymer maltodextrin, recently frequently used in continuous ambulatory peritoneal dialysis (CAPD). "( [Sterile peritonitis after administration of icodextrin].
Dvorsak, B; Ekart, R; Hojs, R; Pecovnik-Balon, B, 2002
)
2.02
"Icodextrin (Extraneal) is a high molecular weight glucose polymer developed specifically for use as an alternative osmotic agent to dextrose during the once-daily long-dwell exchange in peritoneal dialysis (PD). "( Icodextrin: a review of its use in peritoneal dialysis.
Frampton, JE; Plosker, GL, 2003
)
3.2
"Icodextrin is a glucose polymer obtained from starch hydrolysis. "( Severe peritoneal mononucleosis associated with icodextrin use in continuous ambulatory peritoneal dialysis.
Cirugeda, A; Martín, J; Muñoz, C; Sánchez-Tomero, JA; Sansone, G; Selgas, R, 2003
)
2.02
"Icodextrin is a starch-derived, high molecular weight glucose polymer, which has been shown to promote sustained ultrafiltration equivalent to that achieved with hypertonic (3.86%/4.25%) glucose exchanges during prolonged intraperitoneal dwells (up to 16 h). "( Recommendations for the use of icodextrin in peritoneal dialysis patients.
Agar, J; Collins, J; Disney, A; Harris, DC; Ibels, L; Irish, A; Johnson, DW; Saltissi, D; Suranyi, M, 2003
)
2.05
"Icodextrin is a glucose polymer used as an alternative osmotic agent in peritoneal dialysis (PD) solutions. "( Stability of cefepime in icodextrin peritoneal dialysis solution.
Elwell, RJ; Frye, RF; Volino, LR, 2004
)
2.07
"Icodextrin is a starch-derived glucose polymer that causes sustained ultrafiltration in long dwells in peritoneal dialysis. "( Predictors of a favourable response to icodextrin in peritoneal dialysis patients with ultrafiltration failure.
Blizzard, S; Johnson, DW; Rumpsfeld, M; Wiggins, KJ, 2005
)
2.04
"Icodextrin is a glucose polymer solution that is absorbed slowly from the peritoneal cavity, allowing prolonged "hydroflotation" of the viscera, thereby decreasing adhesion formation."( Icodextrin reduces postoperative adhesion formation in rats without affecting peritoneal metastasis.
Jeekel, H; Marquet, R; ten Raa, S; van den Tol, P; van Eijck, C; van Grevenstein, H, 2005
)
2.49
"Icodextrin is a glucose polymer used as an alternative osmotic agent in peritoneal dialysis (PD) solutions. "( Stability of vancomycin in icodextrin peritoneal dialysis solution.
Elwell, RJ; Nornoo, AO, 2006
)
2.07
"Icodextrin 7.5% is an iso-osmolar, glucose polymer-containing peritoneal dialysis solution with an ultrafiltration potential similar to glucose 3.86%. "( Icodextrin instead of glucose during the daytime dwell in CCPD increases ultrafiltration and 24-h dialysate creatinine clearance.
Donker, AJ; Oe, PL; Peers, E; Posthuma, N; Sayers, J; ter Wee, PM; Verbrugh, HA, 1997
)
3.18
"Icodextrin 7.5% is an isosmolar solution for once-daily use in peritoneal dialysis for patients with end-stage renal failure (ESRF). "( Icodextrin provides long dwell peritoneal dialysis and maintenance of intraperitoneal volume.
Gokal, R; Peers, E, 1998
)
3.19
"Icodextrin-based PD is a risk factor for hyponatraemia and may produce clinically relevant symptoms if, as in our two cases, the hyponatraemia is compounded by other factors."( Peritoneal dialysis: new developments and new problems.
Ahmad, R; Bell, GM; Gradden, CW, 2001
)
1.75
"Icodextrin is a high molecular weight, starch-derived glucose polymer, which is capable of inducing sustained ultrafiltration over prolonged (12-16 hour) peritoneal dialysis (PD) dwells. "( Icodextrin as salvage therapy in peritoneal dialysis patients with refractory fluid overload.
Arndt, M; Hamilton, J; Johnson, DW; O'Shea, A; Vincent, K; Watt, R, 2001
)
3.2

Effects

Icodextrin has been shown in randomized controlled trials to benefit fluid management in peritoneal dialysis (PD) It has no effect on the permeability characteristics of thePeritoneal membrane, but increases convective flow through the small-pore system.

ExcerptReferenceRelevance
"Icodextrin has been shown in randomized controlled trials to benefit fluid management in peritoneal dialysis (PD). "( International Icodextrin Use and Association with Peritoneal Membrane Function, Fluid Removal, Patient and Technique Survival.
Badve, SV; Davies, S; Kanjanabuch, T; Kawanishi, H; Kim, YL; McCullough, KP; Mehrotra, R; Perl, J; Pisoni, R; Robinson, B; Wang, AY; Zhao, J, 2022
)
2.52
"Icodextrin has been used as a hyperosmotic agent in PD."( Falsely Elevated Glucose Concentrations in Peritoneal Dialysis Patients Using Icodextrin.
Azak, A; Ceylan, G; Dogan, K; Duranay, M; Kayalp, D; Senes, M; Yucel, D, 2016
)
1.38
"Icodextrin has been widely used as an alternative osmotic agent."( Glucose-based PD solution, but not icodextrin-based PD solution, induces plasminogen activator inhibitor-1 and tissue-type plasminogen activator in human peritoneal mesothelial cells via ERK1/2.
Ito, T; Katsutani, M; Kohno, N; Masaki, T; Yorioka, N, 2007
)
1.34
"Icodextrin has been used to improve ultrafiltration volume without increasing dextrose load."( Favorable changes in lipid metabolism and cardiovascular parameters after icodextrin use in peritoneal dialysis patients.
Furuta, S; Hiramatsu, T; Kakuta, H, 2007
)
1.29
"Icodextrin has no effect on the permeability characteristics of the peritoneal membrane, but increases convective flow through the small-pore system. "( Icodextrin's effects on peritoneal transport.
Ho-dac-Pannekeet, MM; Imholz, AL; Krediet, RT; Struijk, DG,
)
3.02

Actions

Icodextrin can enhance ultrafiltration and consequently improve fluid balance. It can control blood pressure and reduce left ventricular mass for peritoneal dialysis (PD) patients.

ExcerptReferenceRelevance
"Icodextrin can enhance ultrafiltration and consequently improve fluid balance and can control blood pressure and reduce left ventricular mass for peritoneal dialysis (PD) patients. "( Icodextrin reduces the risk of congestive heart failure in peritoneal dialysis patients.
Lin, CL; Lin, SY; Sung, FC; Wang, IK; Yao-Lung, L; Yen, TH, 2018
)
3.37
"Icodextrin may allow greater ultrafiltration during the daytime period in APD, enhancing fluid control."( Effects of icodextrin in automated peritoneal dialysis on blood pressure and bioelectrical impedance analysis.
Brownjohn, AM; Gibson, J; Oldroyd, B; Stables, G; Turney, JH; Woodrow, G, 2000
)
1.42
"Icodextrins (Icos) produce constant linear ultrafiltration (UF). "( Ultrafiltration with icodextrins in continuous ambulatory peritoneal dialysis and automated peritoneal dialysis.
Cappelletti, A; Cavalli, PL; Gandolfo, C; Neri, L; Viglino, G, 2000
)
2.07

Treatment

Icodextrin treatment resulted in a decreasing trend in adhesiolysis time. In icodextrin-treated patients, serum disaccharide (maltose) concentrations increased from 0.05 +/- 0.01 (mean +/- SEM) at baseline, to an average concentration in the follow-up visits of 1.14 +/-0.13 mg/mL.

ExcerptReferenceRelevance
"Icodextrin treatment resulted in a decreasing trend in adhesiolysis time. "( The effect of 4% icodextrin solution on adhesiolysis surgery time at the Hartmann's reversal: a pilot, multicentre, randomized control trial vs lactated Ringer's solution.
Crowe, A; Grönlund, S; Keränen, U; Knight, A; Kössi, J; Uotila-Nieminen, M, 2009
)
2.14
"In icodextrin-treated patients, serum disaccharide (maltose) concentrations increased from 0.05 +/- 0.01 (mean +/- SEM) at baseline, to an average concentration in the follow-up visits of 1.14 +/- 0.13 mg/mL (p < 0.001). "( Serum disaccharides and osmolality in CCPD patients using icodextrin or glucose as daytime dwell.
Donker, AJ; Oe, PL; Peers, EM; Posthuma, N; ter Wee, PM; van Dorp, W; Verbrugh, HA,
)
1
"In icodextrin-treated patients, ultrafiltration rose from 246.5 +/- 60.5 ml (mean +/- SEM) at time 0 to 593.1 +/- 87.4 ml; p < 0.01, at time 1, to 547 +/- 67 ml; p < 0.05, at time 2, and to 586.7 +/- 58.8 ml; p < 0.01, at time 3, the icodextrin administration led to a rise in maltose from 0.02 +/- 0.01 g/l at time 0 to 0.1 +/- 0.1 g/l; p < 0.01, at time 1, to 1.0 +/- 0.09 g/l; p < 0.01, at time 2, and to 1.1 +/- 0.09 g/l; p < 0.01, at time 3, with a fall to zero values at time 4 (NS)."( [Effect of a dialysis solution with icodextrin on ultrafiltration and selected metabolic parameters in patients treated with peritoneal dialysis].
Opatrná, S; Opatrný, K; Racek, J; Sefrna, F; Senft, V; Stehlík, P; Topolcan, O, 2002
)
1.1
"Treatment with icodextrin resulted in elevated plasma levels of maltose (range: 500-1600 mg/L), while levels of isomaltose declined to 9.8 +/- 5.2 mg/L (P < 0.0001 vs."( Maltose and isomaltose in uremic plasma following icodextrin administration.
Burke, RA; Martis, L; Moberly, JB; Patel, H; Shockley, TR, 1998
)
0.89

Toxicity

ExcerptReferenceRelevance
" Clinical adverse effects did not accompany these findings."( Assessment of the effectiveness, safety, and biocompatibility of icodextrin in automated peritoneal dialysis. The Dextrin in APD in Amsterdam (DIANA) Group.
Donker, AJ; Oe, PL; Peers, EM; Posthuma, N; ter Wee, PM; Verbrugh, HA, 2000
)
0.54
"Safety and tolerability (laboratory variables, adverse events, clinical follow-up) were good with no difference between treatments."( A randomized, controlled pilot study of the safety and efficacy of 4% icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery.
Brown, CB; diZerega, GS; Kettel, M; Kobak, W; Martin, D; Peers, EM; Sanfilippo, J; Scrimgeour, A; Verco, SJ; Young, P, 2002
)
0.55
" There were no statistically significant differences between groups for the incidence and severity of adverse events."( A randomized controlled trial to evaluate the efficacy and safety of icodextrin in peritoneal dialysis.
Hamburger, RJ; Morton, AR; Piraino, B; Wolfson, M, 2002
)
0.55
" There were 15 adverse events considered treatment-related in the LRS patients (7."( Gynaecological endoscopic evaluation of 4% icodextrin solution: a European, multicentre, double-blind, randomized study of the efficacy and safety in the reduction of de novo adhesions after laparoscopic gynaecological surgery.
Audebert, A; Chapron, C; Coccia, ME; Crowe, A; Dallay, D; Degueldre, M; Dewilde, R; Dizerega, G; Ford, I; Knight, A; Konincxk, P; Korell, M; Landi, S; Lower, A; McConnachie, A; McVeigh, E; Mettler, L; Nappi, C; Pados, G; Pistofidis, G; Pouly, JL; Rimbach, S; Röemer, T; Schmidt, E; Trew, G; Wallwiener, D, 2011
)
0.63
"The pre-planned safety analysis of the first 300 patients enrolled in this randomized trial did not show any differences in adverse effects related to the use of icodextrin."( Role of icodextrin in the prevention of small bowel obstruction. Safety randomized patients control of the first 300 in the ADEPT trial.
Karlbom, U; Påhlman, L; Sakari, T; Sjödahl, R, 2016
)
1.06

Pharmacokinetics

ExcerptReferenceRelevance
" Plasma levels of icodextrin and metabolites rose during the dwell and declined after drain, closely corresponding to the one-compartment pharmacokinetic model assuming zero-order absorption and first-order elimination."( Pharmacokinetics of icodextrin in peritoneal dialysis patients.
Gehr, T; Hamburger, R; Kucharski, A; Martis, L; Moberly, JB; Mujais, S; Ogrinc, F; Reynolds, R; Sprague, S; Wolfson, M, 2002
)
0.97

Bioavailability

ExcerptReferenceRelevance
" The effective lymphatic absorption rate was not different."( Icodextrin with nitroprusside increases ultrafiltration and peritoneal transport during long CAPD dwells.
de Waart, DR; Douma, CE; Hiralall, JK; Krediet, RT; Struijk, DG, 1998
)
1.74
" No differences in peritoneal fluid absorption rate were observed among the four treatment groups."( Peritoneal fluid kinetics: comparison between polyglucose solution and albumin solution.
Bergström, J; Cheng, HH; Heimbürger, O; Lindholm, B; Wang, T, 1999
)
0.3
" (3) Peritonitis results in increased degradation of icodextrin and a faster increase in dialysate osmolality and therefore better ultrafiltration, whereas the fluid absorption rate does not change."( Effect of peritonitis on peritoneal transport characteristics: glucose solution versus polyglucose solution.
Bergström, J; Cheng, HH; Heimbürger, O; Lindholm, B; Wang, T; Waniewski, J, 2000
)
0.56

Dosage Studied

4% icodextrin was significantly more effective than RLS at preventing adhesion formation, irrespective of the dosing regimen. Until these results are confirmed with appropriate in vivo studies, intermittent intraperitoneal dosing of ceftazidime admixed with icodesxtrin should be used with caution.

ExcerptRelevanceReference
"77 U (bolus) showed that 4% icodextrin was significantly more effective than RLS at preventing adhesion formation, irrespective of the dosing regimen."( Prevention of chemotherapy-induced intraperitoneal adhesion formation in rats by icodextrin at a range of concentrations.
Baines, L; Conroy, SE; Deviren, F; Rodgers, K; Verco, SJ, 2003
)
0.84
" We calculated dose-response curves for peptidoglycan-induced interleukin 6 elaboration in peripheral blood mononuclear cells (PBMCs) from healthy donors and for sterile peritonitis in rats."( Aseptic peritonitis due to peptidoglycan contamination of pharmacopoeia standard dialysis solution.
Costigan, A; Denjoy, N; Giertych, J; Goud, N; Martis, L; Mendoza, O; Mongoven, J; Owen, WF; Patel, M; Perrier, MA; Taminne, M; Verger, C,
)
0.13
"5% icodextrin PD-bags were dosed with gentamicin 20 mg/L (n = 9), vancomycin 1,000 mg/L (n = 9), cefazolin 500 mg/L (n = 9) and ceftazidime 500 mg/L (n = 9) as for intermittent dosing."( Stability of Antibiotics for Intraperitoneal Administration in Extraneal 7.5% Icodextrin Peritoneal Dialysis Bags (STAB Study).
Lipman, J; Naicker, S; Ranganathan, D; Ratanjee, SK; Roberts, JA; Wallis, SC,
)
0.98
"Until these results are confirmed with appropriate in vivo studies, intermittent intraperitoneal dosing of ceftazidime admixed with icodextrin should be used with caution and appropriate clinical monitoring or a suitable alternative antibiotic should be used."( High Pyridine Generation in Ceftazidime-Icodextrin Admixtures Used to Treat Peritoneal Dialysis-associated Peritonitis.
Castelino, RL; Harmanjeet, H; Jose, MD; Kaur, H; Patel, RP; Peterson, GM; Sud, K; Wanandy, T, 2019
)
0.99
" Of these, 9 have intraperitoneal dosing recommendations in the recent International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines, and 7 of the 9 had stability data applicable to clinical practice."( Culture-directed antibiotics in peritoneal dialysis solutions: a systematic review focused on stability and compatibility.
Castelino, R; Ling, CW; Patel, R; Peterson, G; Sud, K; Van, C; Wanandy, T; Yeoh, SF, 2023
)
0.91
"Physicochemical stability has not been demonstrated for all antibiotics with intraperitoneal dosing recommendations in the ISPD peritonitis guidelines."( Culture-directed antibiotics in peritoneal dialysis solutions: a systematic review focused on stability and compatibility.
Castelino, R; Ling, CW; Patel, R; Peterson, G; Sud, K; Van, C; Wanandy, T; Yeoh, SF, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (402)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's32 (7.96)18.2507
2000's206 (51.24)29.6817
2010's138 (34.33)24.3611
2020's26 (6.47)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 47.22

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index47.22 (24.57)
Research Supply Index6.43 (2.92)
Research Growth Index4.91 (4.65)
Search Engine Demand Index75.75 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (47.22)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials75 (13.81%)5.53%
Reviews91 (16.76%)6.00%
Case Studies75 (13.81%)4.05%
Observational2 (0.37%)0.25%
Other300 (55.25%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (25)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
[NCT01170858]100 participants (Actual)Interventional2010-08-31Completed
Does Icodextrin Reduce the Risk of Small Bowel Obstruction? [NCT02318888]1,808 participants (Actual)Interventional2009-12-31Active, not recruiting
The Measurement of Insulin Resistance in Peritoneal Dialysis Patients [NCT01119196]10 participants (Actual)Interventional2010-09-30Completed
Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure [NCT01124227]Phase 326 participants (Actual)Interventional2010-04-30Terminated(stopped due to Due to very specific inclusion criteria the anticipated number of patients was not reached. Inclusion stopped at N=26, allowing for analyzing primary outcomes.)
"Effects of Non-Glucose-Based Peritoneal Dialysis Solution EXTRANEAL on Changes in Leptin Levels and Sympathetic Activity Induced by Conventional Glucose-Based Dialysate DIANEAL in Patients on Peritoneal Dialysis" [NCT01228279]Phase 450 participants (Actual)Interventional2007-07-31Completed
Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in the Treatment of Diabetic CAPD Patients [NCT01219959]Phase 371 participants (Actual)Interventional2010-10-31Completed
[NCT02166359]22 participants (Actual)Interventional2014-06-30Completed
Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis: A Randomized Controlled Trial [NCT05721404]Phase 4194 participants (Anticipated)Interventional2023-05-24Recruiting
Multi-center,Prospective, Randomized Trial ToDemonstrate Improved Metabolic Control of PEN VS Dianeal In Diabetic CAPD and APD Patients - The Impendia Trial [NCT00567398]Phase 343 participants (Actual)Interventional2008-04-30Completed
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine Compared to Icodextrin Alone, an Exploratory Study. [NCT04086212]Phase 210 participants (Anticipated)Interventional2022-09-30Not yet recruiting
Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange in Continuous Ambulatory Peritoneal Dialysis Patients, Compare to 2.5% Dianeal Peritoneal Dialysis Solution. [NCT00725517]Phase 42 participants (Actual)Interventional2005-12-31Completed
A Study to Evaluate the Effects of Icodextrin vs 2.5% Dianeal Used for the Long Dwell in Apd: a Randomized, Open-label Clinical Trial to Analyse the Insulin Resistance Using the Homa Index in Prevalent, Non-diabetic Patients [NCT01021878]Phase 460 participants (Actual)Interventional2009-10-31Completed
Multi-Center, Prospective, Randomized Trial To Demonstrate Improved Metabolic Control of PEN VS Dianeal Only in Diabetic CAPD and APD Patients - The Impendia Trial [NCT00567489]Phase 4137 participants (Actual)Interventional2008-01-31Completed
Effect of Icodextrin on the Treatment Outcome of Peritoneal Dialysis Patients [NCT01044446]Phase 456 participants (Actual)Interventional2010-01-31Completed
Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study [NCT01944852]Phase 4117 participants (Actual)Interventional2013-03-31Completed
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis [NCT00597662]Phase 130 participants (Anticipated)Interventional2008-01-31Completed
Treatment-Resistant Heart Failure (HF) and Peritoneal Ultrafiltration (PUF): A Randomized Prospective Trial of Standard Care Versus Standard Care With Peritoneal Ultrafiltration in Patients With Treatment-Resistant Severe Heart Failure [NCT00368641]Phase 212 participants (Actual)Interventional2006-08-31Terminated(stopped due to Enrollment)
A Phase I Study to Evaluate the Short-term Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution With 30% Icodextrin and 10% Dextrose in Patients in Peritoneal Dialysis, on a Preliminary Basis [NCT05780086]Phase 110 participants (Anticipated)Interventional2023-02-03Recruiting
[NCT01758627]7 participants (Actual)Interventional2013-12-31Completed
Changes in Cardiovascular Hemodynamics During Peritoneal Dialysis; the Effect of Different Dialysates [NCT00119990]15 participants (Anticipated)Interventional2006-01-31Terminated
Randomized Controlled Trial of Bimodal Solution for Peritoneal Dialysis: 24-Hour UF Efficiency Using Bimodal PD Solutions During the Long Dwell [NCT01242904]Phase 236 participants (Actual)Interventional2010-09-30Completed
Open-label Study to Evaluate the Effects of Once Daily Extraneal (7.5% Icodextrin) Peritoneal Dialysis Solution on Triglyceride Levels in Peritoneal Dialysis Patients [NCT00397358]Phase 40 participants (Actual)Interventional2006-11-30Withdrawn(stopped due to Lack of enrollment)
A Phase 1 Interventional Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Intraperitoneal 30% Icodextrin/10% Dextrose Solution in Peritoneal Dialysis Patients [NCT05185999]Phase 110 participants (Anticipated)Interventional2022-10-17Recruiting
The Difference Between Daily and Alternative Day Use of Icodextrin in Peritoneal Dialysis [NCT05943470]Phase 474 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Initiation of Incremental Dialysis With Single Daily Icodextrin Exchange: a Randomized Controlled Trial [NCT06119373]72 participants (Anticipated)Interventional2023-12-01Not yet recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00368641 (1) [back to overview]All-cause Hospitalization (Unadjusted)
NCT00567398 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
NCT00567398 (22) [back to overview]Number of Severe Hypoglycemic Event Requiring Medical Intervention
NCT00567398 (22) [back to overview]Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
NCT00567398 (22) [back to overview]Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
NCT00567398 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of MRI Body Composition at Month 6
NCT00567398 (22) [back to overview]Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
NCT00567398 (22) [back to overview]Change From the Baseline Value in HbA1c at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
NCT00567398 (22) [back to overview]Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
NCT00567489 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
NCT00567489 (22) [back to overview]Change From the Baseline Value in HbA1c at Month 3 and 6
NCT00567489 (22) [back to overview]Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
NCT00567489 (22) [back to overview]Change From Baseline of MRI Body Composition at Month 6
NCT00567489 (22) [back to overview]Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
NCT00567489 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
NCT00567489 (22) [back to overview]Number of Severe Hypoglycemic Event Requiring Medical Intervention
NCT00567489 (22) [back to overview]Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6
NCT00567489 (22) [back to overview]Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
NCT00567489 (22) [back to overview]Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
NCT01021878 (5) [back to overview]Glycated Hemoglobin
NCT01021878 (5) [back to overview]Oral Fasting Serum Glucose
NCT01021878 (5) [back to overview]Serum Insulin
NCT01021878 (5) [back to overview]Total Ultrafiltration
NCT01021878 (5) [back to overview]Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor
NCT01219959 (22) [back to overview]Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
NCT01219959 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
NCT01219959 (22) [back to overview]Number of Severe Hypoglycemic Event Requiring Medical Intervention
NCT01219959 (22) [back to overview]Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
NCT01219959 (22) [back to overview]Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
NCT01219959 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of MRI Body Composition at Month 6
NCT01219959 (22) [back to overview]Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
NCT01219959 (22) [back to overview]Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
NCT01219959 (22) [back to overview]Change From the Baseline Value in HbA1c at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
NCT01219959 (22) [back to overview]Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6

All-cause Hospitalization (Unadjusted)

All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic. (NCT00368641)
Timeframe: 6 to 24 months

Interventionhospitalizations per year (Mean)
Intervention Group5.33
Standard Therapy1.69

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Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6

Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 6 (End of Study)

Interventioncm (Mean)
Non-Glucose Sparing Prescriptions0
Glucose Sparing Prescriptions0.4

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Number of Severe Hypoglycemic Event Requiring Medical Intervention

Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed. (NCT00567398)
Timeframe: Baseline through Month 6 (End of Study)

Interventionevents (Number)
Non-Glucose Sparing Prescriptions1
Glucose Sparing Prescriptions3

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Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6

This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Insulin: Month 3Insulin: Month 6Oral hypoglycemic: Month 3Oral hypoglycemic: Month 6
Glucose Sparing Prescriptions-3.3-3.856.4
Non-Glucose Sparing Prescriptions3.52.91.3-0.5

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Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6

"The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0." (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionScores on a scale (Mean)
Psychology, fatigue: Month 3Psychology, fatigue: Month 6Psychology, cognitive: Month 3Psychology, cognitive: Month 6Neurology, pain: Month 3Neurology, pain: Month 6Neurology, sensory: Month 3Neurology, sensory: Month 6Cardiology: Month 3Cardiology: Month 6Ophthalmology: Month 3Ophthalmology: Month 6Hypoglycemia: Month 3Hypoglycemia: Month 6Hyperglycemia: Month 3Hyperglycemia: Month 6
Glucose Sparing Prescriptions2.39-0.492.661.700.32-1.750.55-3.590.870.292.240.230.12-1.62-1.79-2.82
Non-Glucose Sparing Prescriptions2.342.480.162.23-3.46-1.57-2.25-0.191.183.601.53-0.260.490.50-2.07-0.79

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Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6

"Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0." (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionScore on a Scale (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-2.580.92
Non-Glucose Sparing Prescriptions-2.33-1.60

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Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6

European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.04-0.03
Non-Glucose Sparing Prescriptions-0.01-0.04

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Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6

Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 6 (End of Study)

,
InterventionmL (Mean)
LV End Diastolic VolumeLV End Systolic Volume
Glucose Sparing Prescriptions0.7-0.2
Non-Glucose Sparing Prescriptions2.13.3

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Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6

Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 6 (End of Study)

,
Interventiongrams (Mean)
LV Mass Without Pap MusclesLV Mass With Pap Muscles
Glucose Sparing Prescriptions3.33.5
Non-Glucose Sparing Prescriptions0.61.1

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Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6

Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionpg/mL (Mean)
Insulin: Month 3Insulin: Month 6C-peptide: Month 3C-peptide: Month 6
Glucose Sparing Prescriptions69.496.670.5504.1
Non-Glucose Sparing Prescriptions70.3146.3340.8388.3

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Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6

Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiong/L (Mean)
Albumin: Month 3Albumin: Month 6Total Protein: Month 3Total Protein: Month 6
Glucose Sparing Prescriptions-0.6-0.80.2-0.9
Non-Glucose Sparing Prescriptions-0.10.50.10.7

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Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6

Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionpmol/L (Mean)
Pro-Insulin: Month 3Pro-Insulin: Month 6
Glucose Sparing Prescriptions130.4
Non-Glucose Sparing Prescriptions-1.83

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Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6

Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmmol/L (Mean)
Cholesterol: Month 3Cholesterol: Month 6LDLC: Month 3LDLC: Month 6HDLC: Month 3HDLC: Month 6VLDL: Month 3VLDL: Month 6Triglycerides: Month 3Triglycerides: Month 6
Glucose Sparing Prescriptions-0.5-0.4-0.2-0.100-0.3-0.3-0.7-0.6
Non-Glucose Sparing Prescriptions0.100.10.100-0.1-0.1-0.1-0.3

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Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6

Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmg/dL (Mean)
Lp(a): Month 3Lp(a): Month 6Apo A1: Month 3Apo A1: Month 6Apo B: Month 3Apo B: Month 6
Glucose Sparing Prescriptions3.36.8-9.3-10.5-8.5-3.6
Non-Glucose Sparing Prescriptions2.36.7-2.1-3.85.35.2

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Change From Baseline of MRI Body Composition at Month 6

Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 6 (End of Study)

,
InterventionmL (Mean)
Abdominal Visceral Fat Volume: Month 6Abdominal Subcutaneous Fat Volume: Month 6
Glucose Sparing Prescriptions-64.8-3.3
Non-Glucose Sparing Prescriptions-49-12

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Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6

Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished (NCT00567398)
Timeframe: Baseline and Month 6 (End of Study)

,
Interventionparticipants (Number)
+2 Score+1 Score0 Score-1 Score-2 Score-3 Score
Glucose Sparing Prescriptions224571740
Non-Glucose Sparing Prescriptions119762031

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Change From the Baseline Value in HbA1c at Month 3 and 6

HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.6-0.6
Non-Glucose Sparing Prescriptions0.20

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Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6

Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiongrams (Mean)
Protein: Month 3Protein: Month 6Calories: Month 3Calories: Month 6
Glucose Sparing Prescriptions-4.94.5-199.1108
Non-Glucose Sparing Prescriptions-5.6-0.1-76.830.9

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Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6

Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmg/dL (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-1.9-2.9
Non-Glucose Sparing Prescriptions0.4-1.0

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Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6

Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiong/kg/day (Mean)
PNA: Month 3PNA: Month 6nPNA: Month 3nPNA: Month 6
Glucose Sparing Prescriptions12.812.90.20.2
Non-Glucose Sparing Prescriptions-0.8100

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Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6

Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionkg (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.2-0.7
Non-Glucose Sparing Prescriptions-0.20.2

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Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6

Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionkg/m2 (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.1-0.3
Non-Glucose Sparing Prescriptions-0.10.1

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Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6

Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567398)
Timeframe: Baseline, Month 6 (End of Study)

InterventionPercent (Mean)
Non-Glucose Sparing Prescriptions-0.3
Glucose Sparing Prescriptions0.9

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Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6

Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionpg/mL (Mean)
Insulin: Month 3Insulin: Month 6C-peptide: Month 3C-peptide: Month 6
Glucose Sparing Prescriptions69.496.670.5504.1
Non-Glucose Sparing Prescriptions70.3146.3340.8388.3

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Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6

Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionpmol/L (Mean)
Pro-Insulin: Month 3Pro-Insulin: Month 6
Glucose Sparing Prescriptions130.4
Non-Glucose Sparing Prescriptions-1.83

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Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6

Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmmol/L (Mean)
Cholesterol: Month 3Cholesterol: Month 6LDLC: Month 3LDLC: Month 6HDLC: Month 3HDLC: Month 6VLDL: Month 3VLDL: Month 6Triglycerides: Month 3Triglycerides: Month 6
Glucose Sparing Prescriptions-0.5-0.4-0.2-0.100-0.3-0.3-0.7-0.6
Non-Glucose Sparing Prescriptions0.100.10.100-0.1-0.1-0.1-0.3

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Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6

Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmg/dL (Mean)
Lp(a): Month 3Lp(a): Month 6Apo A1: Month 3Apo A1: Month 6Apo B: Month 3Apo B: Month 6
Glucose Sparing Prescriptions3.36.8-9.3-10.5-8.5-3.6
Non-Glucose Sparing Prescriptions2.36.7-2.1-3.85.35.2

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Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6

Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiong/L (Mean)
Albumin: Month 3Albumin: Month 6Total Protein: Month 3Total Protein: Month 6
Glucose Sparing Prescriptions-0.6-0.80.2-0.9
Non-Glucose Sparing Prescriptions-0.10.50.10.7

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Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6

Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionkg/m2 (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.1-0.3
Non-Glucose Sparing Prescriptions-0.10.1

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Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6

Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionkg (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.2-0.7
Non-Glucose Sparing Prescriptions-0.20.2

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Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6

Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiong/kg/day (Mean)
PNA: Month 3PNA: Month 6nPNA: Month 3nPNA: Month 6
Glucose Sparing Prescriptions12.812.90.20.2
Non-Glucose Sparing Prescriptions-0.8100

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Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6

Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmg/dL (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-1.9-2.9
Non-Glucose Sparing Prescriptions0.4-1.0

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Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6

Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiongrams (Mean)
Protein: Month 3Protein: Month 6Calories: Month 3Calories: Month 6
Glucose Sparing Prescriptions-4.94.5-199.1108
Non-Glucose Sparing Prescriptions-5.6-0.1-76.830.9

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Change From the Baseline Value in HbA1c at Month 3 and 6

HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.6-0.6
Non-Glucose Sparing Prescriptions0.20

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Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6

"Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease.~The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished" (NCT00567489)
Timeframe: Baseline and Month 6 (End of Study)

,
Interventionparticipants (Number)
+2 Score+1 Score0 Score-1 Score-2 Score-3 Score
Glucose Sparing Prescriptions224571740
Non-Glucose Sparing Prescriptions119762031

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Change From Baseline of MRI Body Composition at Month 6

Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 6 (End of Study)

,
InterventionmL (Mean)
Abdominal Visceral Fat Volume: Month 6Abdominal Subcutaneous Fat Volume: Month 6
Glucose Sparing Prescriptions-64.8-3.3
Non-Glucose Sparing Prescriptions-49-12

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Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6

"The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0." (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionScores on a scale (Mean)
Psychology, fatigue: Month 3Psychology, fatigue: Month 6Psychology, cognitive: Month 3Psychology, cognitive: Month 6Neurology, pain: Month 3Neurology, pain: Month 6Neurology, sensory: Month 3Neurology, sensory: Month 6Cardiology: Month 3Cardiology: Month 6Ophthalmology: Month 3Ophthalmology: Month 6Hypoglycemia: Month 3Hypoglycemia: Month 6Hyperglycemia: Month 3Hyperglycemia: Month 6
Glucose Sparing Prescriptions2.39-0.492.661.700.32-1.750.55-3.590.870.292.240.230.12-1.62-1.79-2.82
Non-Glucose Sparing Prescriptions2.342.480.162.23-3.46-1.57-2.25-0.191.183.601.53-0.260.490.50-2.07-0.79

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Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6

Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 6 (End of Study)

InterventionPercent (Mean)
Non-Glucose Sparing Prescriptions-0.3
Glucose Sparing Prescriptions0.9

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Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6

Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 6 (End of Study)

Interventioncm (Mean)
Non-Glucose Sparing Prescriptions0
Glucose Sparing Prescriptions0.4

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Number of Severe Hypoglycemic Event Requiring Medical Intervention

Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed. (NCT00567489)
Timeframe: Baseline through Month 6 (End of Study)

Interventionevents (Number)
Non-Glucose Sparing Prescriptions1
Glucose Sparing Prescriptions3

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Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6

This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Insulin: Month 3Insulin: Month 6Oral hypoglycemic: Month 3Oral hypoglycemic: Month 6
Glucose Sparing Prescriptions-3.3-3.856.4
Non-Glucose Sparing Prescriptions3.52.91.3-0.5

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Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6

"Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0." (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionScore on a Scale (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-2.580.92
Non-Glucose Sparing Prescriptions-2.33-1.60

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Change From Baseline in QOL Based on the EQ 5D Questionnaire Index at Month 3 and 6

European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.04-0.03
Non-Glucose Sparing Prescriptions-0.01-0.04

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Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6

Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 6 (End of Study)

,
InterventionmL (Mean)
LV End Diastolic VolumeLV End Systolic Volume
Glucose Sparing Prescriptions0.7-0.2
Non-Glucose Sparing Prescriptions2.13.3

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Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6

Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT00567489)
Timeframe: Baseline, Month 6 (End of Study)

,
Interventiongrams (Mean)
LV Mass Without Pap MusclesLV Mass With Pap Muscles
Glucose Sparing Prescriptions3.33.5
Non-Glucose Sparing Prescriptions0.61.1

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Glycated Hemoglobin

"Adjusted glycated hemoglobin was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of HbA1c was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.~Glycated hemoglobin was measured by high-performance liquid chromatography." (NCT01021878)
Timeframe: 3 months

Interventionpercentage of haemoglobin (Mean)
Icodextrin4.97
Dextrose4.86

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Oral Fasting Serum Glucose

"Serum glucose measured in oral fasting but not peritoneal fasting.~For this outcome we compared groups using analysis of covariance (ANCOVA) using the baseline values as covariate, groups as the fixed factor and the value obtained at 90 days as the dependent variable. Significance level for alpha was setting at < 0.05." (NCT01021878)
Timeframe: 3 months

Interventionmg/dl (Mean)
Icodextrin92.8
Dextrose94.5

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Serum Insulin

Serum insulin was log-transformed to meet all criteria for ANCOVA. The baseline value was treated as covariate, groups as the fixed factor and the serum insulin at 3 months as the dependent variable. Serum insulin was measured in oral fasting by chemioluminescense. (NCT01021878)
Timeframe: 3 months

Interventionlog(mmol/L) (Mean)
Icodextrin0.79
Dextrose0.90

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Total Ultrafiltration

Total ultrafiltration obtained in 24 hours was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of total ultrafiltration was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable. (NCT01021878)
Timeframe: 3 months

Interventionmillilitre (Mean)
Icodextrin958
Dextrose656

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Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor

"Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows:~(fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405" (NCT01021878)
Timeframe: 3 months

InterventionIR score (Mean)
Icodextrin1.49
Dextrose1.89

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Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6

Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 6 (End of Study)

InterventionPercent (Mean)
Non-Glucose Sparing Prescriptions-0.3
Glucose Sparing Prescriptions0.9

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Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6

Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 6 (End of Study)

Interventioncm (Mean)
Non-Glucose Sparing Prescriptions0
Glucose Sparing Prescriptions0.4

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Number of Severe Hypoglycemic Event Requiring Medical Intervention

Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed. (NCT01219959)
Timeframe: Baseline through Month 6 (End of Study)

Interventionevents (Number)
Non-Glucose Sparing Prescriptions1
Glucose Sparing Prescriptions3

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Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6

This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Insulin: Month 3Insulin: Month 6Oral hypoglycemic: Month 3Oral hypoglycemic: Month 6
Glucose Sparing Prescriptions-3.3-3.856.4
Non-Glucose Sparing Prescriptions3.52.91.3-0.5

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Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6

"The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0." (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionScores on a scale (Mean)
Psychology, fatigue: Month 3Psychology, fatigue: Month 6Psychology, cognitive: Month 3Psychology, cognitive: Month 6Neurology, pain: Month 3Neurology, pain: Month 6Neurology, sensory: Month 3Neurology, sensory: Month 6Cardiology: Month 3Cardiology: Month 6Ophthalmology: Month 3Ophthalmology: Month 6Hypoglycemia: Month 3Hypoglycemia: Month 6Hyperglycemia: Month 3Hyperglycemia: Month 6
Glucose Sparing Prescriptions2.39-0.492.661.700.32-1.750.55-3.590.870.292.240.230.12-1.62-1.79-2.82
Non-Glucose Sparing Prescriptions2.342.480.162.23-3.46-1.57-2.25-0.191.183.601.53-0.260.490.50-2.07-0.79

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Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6

"Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0." (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionScore on a Scale (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-2.580.92
Non-Glucose Sparing Prescriptions-2.33-1.60

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Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6

European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.04-0.03
Non-Glucose Sparing Prescriptions-0.01-0.04

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Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6

Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 6 (End of Study)

,
InterventionmL (Mean)
LV End Diastolic VolumeLV End Systolic Volume
Glucose Sparing Prescriptions0.7-0.2
Non-Glucose Sparing Prescriptions2.13.3

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Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6

Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 6 (End of Study)

,
Interventiongrams (Mean)
LV Mass Without Pap MusclesLV Mass With Pap Muscles
Glucose Sparing Prescriptions3.33.5
Non-Glucose Sparing Prescriptions0.61.1

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Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6

Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionpmol/L (Mean)
Pro-Insulin: Month 3Pro-Insulin: Month 6
Glucose Sparing Prescriptions130.4
Non-Glucose Sparing Prescriptions-1.83

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Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6

Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmmol/L (Mean)
Cholesterol: Month 3Cholesterol: Month 6LDLC: Month 3LDLC: Month 6HDLC: Month 3HDLC: Month 6VLDL: Month 3VLDL: Month 6Triglycerides: Month 3Triglycerides: Month 6
Glucose Sparing Prescriptions-0.5-0.4-0.2-0.100-0.3-0.3-0.7-0.6
Non-Glucose Sparing Prescriptions0.100.10.100-0.1-0.1-0.1-0.3

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Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6

Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmg/dL (Mean)
Lp(a): Month 3 (n=118,120)Lp(a): Month 6Apo A1: Month 3Apo A1: Month 6Apo B: Month 3Apo B: Month 6
Glucose Sparing Prescriptions3.36.8-9.3-10.5-8.5-3.6
Non-Glucose Sparing Prescriptions2.36.7-2.1-3.85.35.2

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Change From Baseline of MRI Body Composition at Month 6

Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 6 (End of Study)

,
InterventionmL (Mean)
Abdominal Visceral Fat Volume: Month 6Abdominal Subcutaneous Fat Volume: Month 6
Glucose Sparing Prescriptions-64.8-3.3
Non-Glucose Sparing Prescriptions-49-12

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Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6

Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionpg/mL (Mean)
Insulin: Month 3Insulin: Month 6C-peptide: Month 3C-peptide: Month 6
Glucose Sparing Prescriptions69.496.670.5504.1
Non-Glucose Sparing Prescriptions70.3146.3340.8388.3

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Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6

Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished. (NCT01219959)
Timeframe: Baseline and Month 6 (End of Study)

,
Interventionparticipants (Number)
+2 Score+1 Score0 Score-1 Score-2 Score-3 Score
Glucose Sparing Prescriptions224571740
Non-Glucose Sparing Prescriptions119762031

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Change From the Baseline Value in HbA1c at Month 3 and 6

HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
InterventionPercent Change (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.6-0.6
Non-Glucose Sparing Prescriptions0.20

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Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6

Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiongrams (Mean)
Protein: Month 3Protein: Month 6Calories: Month 3Calories: Month 6
Glucose Sparing Prescriptions-4.94.5-199.1108
Non-Glucose Sparing Prescriptions-5.6-0.1-76.830.9

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Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6

Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionmg/dL (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-1.9-2.9
Non-Glucose Sparing Prescriptions0.4-1.0

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Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6

Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiong/L (Mean)
Albumin: Month 3Albumin: Month 6Total Protein: Month 3Total Protein: Month 6
Glucose Sparing Prescriptions-0.6-0.80.2-0.9
Non-Glucose Sparing Prescriptions-0.10.50.10.7

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Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6

Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventiong/kg/day (Mean)
PNA: Month 3PNA: Month 6nPNA: Month 3nPNA: Month 6
Glucose Sparing Prescriptions12.812.90.20.2
Non-Glucose Sparing Prescriptions-0.8100

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Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6

Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionkg (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.2-0.7
Non-Glucose Sparing Prescriptions-0.20.2

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Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6

Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0. (NCT01219959)
Timeframe: Baseline, Month 3, Month 6 (End of Study)

,
Interventionkg/m2 (Mean)
Month 3Month 6
Glucose Sparing Prescriptions-0.1-0.3
Non-Glucose Sparing Prescriptions-0.10.1

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