glyburide and Hypoglycemia studies

Glyburide: An antidiabetic sulfonylurea derivative with actions like those of chlorpropamide
glyburide : An N-sulfonylurea that is acetohexamide in which the acetyl group is replaced by a 2-(5-chloro-2-methoxybenzamido)ethyl group.

Hypoglycemia: A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH.

Research Excerpts

Excerpt	Relevance	Reference
" The relationships between glyburide concentration and the time since the last intake of glyburide and between fetal glyburide concentration and neonatal hypoglycemia were modeled with linear or logistic regressions using fractional polynomials."	9.34	Transplacental transfer of glyburide in women with gestational diabetes and neonatal hypoglycemia risk. ( Alvarez, JC; Bouchghoul, H; Bouyer, J; Senat, MV; Verstuyft, C, 2020)
"Reported rates of hypoglycemia in patients with type 2 diabetes mellitus are lower with glimepiride as compared to glyburide."	9.20	Counterregulatory responses to hypoglycemia differ between glimepiride and glyburide in non diabetic individuals. ( Davis, SN; Joy, NG; Tate, DB, 2015)
"Severe hypoglycemia, the most serious side effect of sulfonylurea therapy, has been reported to occur more frequently with glyburide than glimepiride."	9.12	Effects of glimepiride and glyburide on glucose counterregulation and recovery from hypoglycemia. ( Cryer, PE; Fender, AB; Gerich, JE; Gosmanov, NR; Meyer, C; Nihalani, A; Sinkin, JC; Szoke, E, 2006)
"Sulfonylurea-induced hypoglycemia after the oral administration of glibenclamide is not accentuated by the coadministration of vildagliptin."	9.12	The dipeptidyl peptidase 4 inhibitor vildagliptin does not accentuate glibenclamide-induced hypoglycemia but reduces glucose-induced glucagon-like peptide 1 and gastric inhibitory polypeptide secretion. ( El-Ouaghlidi, A; Foley, J; Holmes, D; Holst, JJ; Nauck, MA; Rehring, E; Schweizer, A, 2007)
"The sulfonylurea (SU) glyburide may cause severe and prolonged episodes of hypoglycemia."	9.10	The sulfonylurea glyburide induces impairment of glucagon and growth hormone responses during mild insulin-induced hypoglycemia. ( Appelman, AM; Erkelens, DW; ter Braak, EW; van der Tweel, I; van Haeften, TW, 2002)
"Glyburide was associated with a 52% greater risk of experiencing at least one episode of hypoglycemia compared with other secretagogues (relative risk 1."	8.84	A systematic review and meta-analysis of hypoglycemia and cardiovascular events: a comparison of glyburide with other secretagogues and with insulin. ( Clase, CM; Cukierman, T; Gangji, AS; Gerstein, HC; Goldsmith, CH, 2007)
" As with other oral hypoglycemics, the use of glyburide in pregnancy has been limited by fears of neonatal hypoglycemia following fetal exposure."	8.84	Safety of glyburide for gestational diabetes: a meta-analysis of pregnancy outcomes. ( Koren, G; Moretti, ME; Rezvani, M, 2008)
"Intravenous glyburide has demonstrated safety when used for attenuation of cerebral edema, although safety data are lacking for enteral glyburide when used for this indication."	8.02	Risk Factors for Hypoglycemia with the Use of Enteral Glyburide in Neurocritical Care Patients. ( Armahizer, MJ; Howard, AK; Kalasapudi, L; Morris, NA; Sansur, C; Seung, H, 2021)
" glipizide) and serious hypoglycemia."	7.85	Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia. ( Archdeacon, P; Axtman, S; Carnahan, RM; Cavagnaro, E; Chrischilles, EA; Fuller, C; Gagne, JJ; Hampp, C; Hennessy, S; Iyer, A; Leonard, CE; Panozzo, CA; Toh, S; Wang, SV; Woodworth, TS; Zhou, M, 2017)
" The objective of this nationwide study was to compare the risk of cardiovascular disease (CVD), all-cause mortality and severe hypoglycemia in patients with type 2 diabetes (T2D) starting second-line treatment with either metformin+sulphonylurea or metformin+dipeptidyl peptidase-4 inhibitor (DPP-4i)."	7.83	Sulphonylurea compared to DPP-4 inhibitors in combination with metformin carries increased risk of severe hypoglycemia, cardiovascular events, and all-cause mortality. ( Bodegard, J; Eriksson, JW; Nathanson, D; Norhammar, A; Nyström, T; Thuresson, M, 2016)
"To (a) identify whether hemoglobin A1c remained equivalent in patients converted from glyburide to glipizide, (b) evaluate the prevalence of hypoglycemia during treatment with glyburide or glipizide, (c) compare change in glycemic control for renally impaired versus nonimpaired patients, and (d) analyze dosage conversion ratios selected by providers and measures of patient follow-up after conversion including time until A1c measurement and number of glipizide dose titrations."	7.77	Glycemic control and hypoglycemia in Veterans Health Administration patients converted from glyburide to glipizide. ( Cantrell, M; Egge, JA; Shaw, RF; Skoff, RA; Waterbury, NV, 2011)
"The objective of this study was to evaluate whether orally administered anti-infectives increase the risk of severe hypoglycemia in users of glipizide or glyburide."	7.76	Anti-infectives and the risk of severe hypoglycemia in users of glipizide or glyburide. ( Bilker, WB; Brensinger, CM; Hennessy, S; Schelleman, H; Wan, F, 2010)
"The objective of this study was to measure the serum insulin and C-peptide concentrations among diabetic patients known to be taking sulfonylurea agents who presented to the emergency department with hypoglycemia thought to be due to therapeutic usage as opposed to overdose."	7.76	Quantitative insulin and C-peptide levels among ED patients with sulfonylurea-induced hypoglycemia-a prospective case series. ( Aguilera, E; Fasano, CJ; Heard, K; O'Malley, GF; Rowden, AK, 2010)
"Severe and resistant hypoglycemia occurred in two patients with diabetes mellitus who were receiving concomitant gatifloxacin and glyburide."	7.72	Severe and resistant hypoglycemia associated with concomitant gatifloxacin and glyburide therapy. ( Bélanger, C; Cossette, P; LeBlanc, M, 2004)
"Repaglinide is an insulin secretion enhancer with a different mechanism of action to the sulphonylureas, which means it does not continuously stimulate insulin secretion."	6.41	[Repaglinide, potentially a therapeutic improvement for diabetes mellitus type 2]. ( Rutten, GE, 2001)
"Pasireotide (SOM230) is a multireceptor-targeted somatostatin analogue with a 39-, 30- and 5-fold higher binding affinity for sstr5, sstr1 and sstr3, respectively, and a slightly lower (0."	5.42	Pasireotide (SOM230) prevents sulfonylurea-induced hypoglycemia in rats. ( Schmid, HA, 2015)
"Glyburide is an effective treatment for reaching glycaemic goals during pregnancy in women with GDM."	5.41	Glyburide therapy for gestational diabetes: Glycaemic control, maternal hypoglycaemia, and treatment failure. ( Affres, H; Bouchghoul, H; Bouyer, J; Coustols-Valat, M; Deruelle, P; Letourneau, A; Senat, MV, 2021)
"Hypoglycemia was defined as a blood glucose of less than 50 mg/dL, further classified as "severe hypoglycemia" if the event required the assistance of another person for resuscitation, "symptomatic hypoglycemia" if it was associated with typical neurogenic symptoms, or "asymptomatic hypoglycemia" if the biochemical reading was less than 50 mg/dL with no symptoms or accompanied by mild symptoms that did not impair the patient's ability to function."	5.37	Hypoglycemia in glyburide-treated gestational diabetes: is it dose-dependent? ( Brustman, L; El Daouk, M; Fuchs, A; Langer, O; Rosenn, B; Scarpelli, S, 2011)
" The relationships between glyburide concentration and the time since the last intake of glyburide and between fetal glyburide concentration and neonatal hypoglycemia were modeled with linear or logistic regressions using fractional polynomials."	5.34	Transplacental transfer of glyburide in women with gestational diabetes and neonatal hypoglycemia risk. ( Alvarez, JC; Bouchghoul, H; Bouyer, J; Senat, MV; Verstuyft, C, 2020)
"An evaluation of 82 patients with gestational diabetes was performed; 30 were insulin-treated, 27 were managed by diet only, and 25 were patients treated with glyburide."	5.32	Undiagnosed asymptomatic hypoglycemia: diet, insulin, and glyburide for gestational diabetic pregnancy. ( Ben-Haroush, A; Chen, R; Hod, M; Langer, O; Rosenn, B; Yogev, Y, 2004)
"Reported rates of hypoglycemia in patients with type 2 diabetes mellitus are lower with glimepiride as compared to glyburide."	5.20	Counterregulatory responses to hypoglycemia differ between glimepiride and glyburide in non diabetic individuals. ( Davis, SN; Joy, NG; Tate, DB, 2015)
"The only significant difference in outcome between the 2 treatment drugs was that maternal weight gain during pregnancy was less in the metformin (n=40) than in the glyburide group (n=32) (10."	5.14	Metformin compared with glyburide for the management of gestational diabetes. ( Bertini, AM; Bizato, J; de Souza, BV; Pacheco, C; Ribeiro, TE; Silva, JC, 2010)
"Severe hypoglycemia, the most serious side effect of sulfonylurea therapy, has been reported to occur more frequently with glyburide than glimepiride."	5.12	Effects of glimepiride and glyburide on glucose counterregulation and recovery from hypoglycemia. ( Cryer, PE; Fender, AB; Gerich, JE; Gosmanov, NR; Meyer, C; Nihalani, A; Sinkin, JC; Szoke, E, 2006)
"Sulfonylurea-induced hypoglycemia after the oral administration of glibenclamide is not accentuated by the coadministration of vildagliptin."	5.12	The dipeptidyl peptidase 4 inhibitor vildagliptin does not accentuate glibenclamide-induced hypoglycemia but reduces glucose-induced glucagon-like peptide 1 and gastric inhibitory polypeptide secretion. ( El-Ouaghlidi, A; Foley, J; Holmes, D; Holst, JJ; Nauck, MA; Rehring, E; Schweizer, A, 2007)
"The sulfonylurea (SU) glyburide may cause severe and prolonged episodes of hypoglycemia."	5.10	The sulfonylurea glyburide induces impairment of glucagon and growth hormone responses during mild insulin-induced hypoglycemia. ( Appelman, AM; Erkelens, DW; ter Braak, EW; van der Tweel, I; van Haeften, TW, 2002)
"The purpose of this study was to compare glycemic control and hypoglycemia rates with Mix75/25 versus glyburide, and with preprandial versus postprandial Mix75/25, in patients aged 60 to 80 years with type 2 diabetes mellitus and persistent hyperglycemia on sulfonylurea therapy."	5.10	Comparative efficacy of preprandial or postprandial Humalog Mix75/25 versus glyburide in patients 60 to 80 years of age with type 2 diabetes mellitus. ( Erickson, P; Fövènyi, J; Grzywa, M; Herz, M; Milicevic, Z; Pelikanova, T; Sun, B, 2002)
" Glyburide significantly increased the risk of any neonatal hypoglycemia [risk ratio (RR), 1."	4.95	Comparison of glyburide and insulin in the management of gestational diabetes: A meta-analysis. ( Chen, L; Chen, Y; Feng, W; Irwin, DM; Liu, Y; Si, X; Song, R, 2017)
"Compared with other oral insulinotropic agents, gliclazide significantly reduced HbA1c with no difference regarding hypoglycemia risk."	4.91	Systematic review and meta-analysis of the efficacy and hypoglycemic safety of gliclazide versus other insulinotropic agents. ( Chan, SP; Colagiuri, S, 2015)
"Glyburide was associated with a 52% greater risk of experiencing at least one episode of hypoglycemia compared with other secretagogues (relative risk 1."	4.84	A systematic review and meta-analysis of hypoglycemia and cardiovascular events: a comparison of glyburide with other secretagogues and with insulin. ( Clase, CM; Cukierman, T; Gangji, AS; Gerstein, HC; Goldsmith, CH, 2007)
" As with other oral hypoglycemics, the use of glyburide in pregnancy has been limited by fears of neonatal hypoglycemia following fetal exposure."	4.84	Safety of glyburide for gestational diabetes: a meta-analysis of pregnancy outcomes. ( Koren, G; Moretti, ME; Rezvani, M, 2008)
"4%) had at least one episode of hypoglycemia, most often in the setting of glyburide."	4.12	Antenatal maternal hypoglycemia in women with gestational diabetes mellitus and neonatal outcomes. ( Cruz, M; Davitt, C; Harrison, RK; Palatnik, A; Saravanan, V, 2022)
"Metformin is beneficial for GDM women to control total GWG compared with insulin, regulate fetal birth weight more than insulin and glyburide, and increase the risk of unmet treatment targets compared with insulin."	4.12	Efficacy and safety of hypoglycemic agents on gestational diabetes mellitus in women: A Bayesian network analysis of randomized controlled trials. ( Chen, H; Cui, W; Guo, H; Huang, L; Jing, Y; Liu, X; Song, L; Sun, B; Wang, M; Wang, N; Wang, T; Xu, J, 2022)
"Intravenous glyburide has demonstrated safety when used for attenuation of cerebral edema, although safety data are lacking for enteral glyburide when used for this indication."	4.02	Risk Factors for Hypoglycemia with the Use of Enteral Glyburide in Neurocritical Care Patients. ( Armahizer, MJ; Howard, AK; Kalasapudi, L; Morris, NA; Sansur, C; Seung, H, 2021)
"The use of medications such as glyburide, neuroleptics and benzodiazepines is potentially dangerous in the elderly, as they are linked to adverse drug events such as hypoglycemia and serious falls."	3.88	The Burden of Repeat Prescribing Medications after a Related Adverse Drug Event. ( Clemens, KK; Richard, L; Shariff, SZ; Welk, B; Winick-Ng, J, 2018)
" glipizide) and serious hypoglycemia."	3.85	Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia. ( Archdeacon, P; Axtman, S; Carnahan, RM; Cavagnaro, E; Chrischilles, EA; Fuller, C; Gagne, JJ; Hampp, C; Hennessy, S; Iyer, A; Leonard, CE; Panozzo, CA; Toh, S; Wang, SV; Woodworth, TS; Zhou, M, 2017)
"The 5 mg/day glyburide dose did not increase maternal hypoglycemia (26% in the 2."	3.83	Examining the Starting Dose of Glyburide in Gestational Diabetes. ( Biggio, JR; Glover, AV; Harper, LM; Tita, A, 2016)
" The objective of this nationwide study was to compare the risk of cardiovascular disease (CVD), all-cause mortality and severe hypoglycemia in patients with type 2 diabetes (T2D) starting second-line treatment with either metformin+sulphonylurea or metformin+dipeptidyl peptidase-4 inhibitor (DPP-4i)."	3.83	Sulphonylurea compared to DPP-4 inhibitors in combination with metformin carries increased risk of severe hypoglycemia, cardiovascular events, and all-cause mortality. ( Bodegard, J; Eriksson, JW; Nathanson, D; Norhammar, A; Nyström, T; Thuresson, M, 2016)
" We report here a case of hypoglycemia caused by an illicit sexual enhancement medication containing an extremely large amount of the sulfonylurea drug glibenclamide together with a moderate amount sildenafil citrate."	3.81	A case of hypoglycemia due to illegitimate sexual enhancement medication. ( Kuramoto, N; Kurose, T; Seino, Y; Yabe, D, 2015)
"The risk for hypoglycemia when taking glyburide compared with modified-release gliclazide remains to be established in older adults in routine care."	3.81	The Hypoglycemic Risk of Glyburide (Glibenclamide) Compared with Modified-Release Gliclazide. ( Clemens, KK; Dixon, SN; Fleet, JL; Garg, AX; Hramiak, I; McArthur, E, 2015)
"To determine the risk of hypoglycemia and associated costs in older patients prescribed glipizide or glyburide who fill a prescription for an antimicrobial drug."	3.80	Hypoglycemia after antimicrobial drug prescription for older patients using sulfonylureas. ( Goodwin, JS; Kuo, YF; Lin, YL; Parekh, TM; Raji, M; Tan, A, 2014)
"Neonatal chemical hypoglycemia occurs more frequently in infants from women with type 2 diabetes and GDM treated with glyburide or insulin."	3.78	Neonatal chemical hypoglycemia in newborns from pregnancies complicated by type 2 and gestational diabetes mellitus - the importance of neonatal ponderal index. ( Aguayo, J; Hanley, AA; Kim, JH; Moore, TR; Ramos, GA; Warshak, CR, 2012)
"Overall, 19% of patients who received a sulfonylurea experienced at least one episode of hypoglycemia: 22% receiving glyburide, 19% receiving glimepiride, and 16% receiving glipizide."	3.78	Hypoglycemia in hospitalized patients treated with sulfonylureas. ( Coley, KC; Deusenberry, CM; Donihi, AC; Korytkowski, MT, 2012)
"To (a) identify whether hemoglobin A1c remained equivalent in patients converted from glyburide to glipizide, (b) evaluate the prevalence of hypoglycemia during treatment with glyburide or glipizide, (c) compare change in glycemic control for renally impaired versus nonimpaired patients, and (d) analyze dosage conversion ratios selected by providers and measures of patient follow-up after conversion including time until A1c measurement and number of glipizide dose titrations."	3.77	Glycemic control and hypoglycemia in Veterans Health Administration patients converted from glyburide to glipizide. ( Cantrell, M; Egge, JA; Shaw, RF; Skoff, RA; Waterbury, NV, 2011)
"The objective of this study was to evaluate whether orally administered anti-infectives increase the risk of severe hypoglycemia in users of glipizide or glyburide."	3.76	Anti-infectives and the risk of severe hypoglycemia in users of glipizide or glyburide. ( Bilker, WB; Brensinger, CM; Hennessy, S; Schelleman, H; Wan, F, 2010)
"The objective of this study was to measure the serum insulin and C-peptide concentrations among diabetic patients known to be taking sulfonylurea agents who presented to the emergency department with hypoglycemia thought to be due to therapeutic usage as opposed to overdose."	3.76	Quantitative insulin and C-peptide levels among ED patients with sulfonylurea-induced hypoglycemia-a prospective case series. ( Aguilera, E; Fasano, CJ; Heard, K; O'Malley, GF; Rowden, AK, 2010)
"During the 7-year study period, 909 elderly patients receiving glyburide were admitted with a diagnosis of hypoglycemia."	3.72	Drug-drug interactions among elderly patients hospitalized for drug toxicity. ( Juurlink, DN; Kopp, A; Laupacis, A; Mamdani, M; Redelmeier, DA, 2003)
"Severe and resistant hypoglycemia occurred in two patients with diabetes mellitus who were receiving concomitant gatifloxacin and glyburide."	3.72	Severe and resistant hypoglycemia associated with concomitant gatifloxacin and glyburide therapy. ( Bélanger, C; Cossette, P; LeBlanc, M, 2004)
" Drug-induced asterixis (clozapine, benperidol) amplified by relative hypoglycemia was therefore assumed, and symptoms disappeared after oral antidiabetics were reduced."	3.69	[Drug-induced asterixis amplified by relative hypoglycemia]. ( Hufnagel, A; Poersch, M; Smolenski, C, 1996)
"Influence of piroxicam (PX) on glibenclamide (GL) induced hypoglycemia has been studied in rats, healthy human volunteers and diabetics."	3.68	Potentiation of hypoglycemic response of glibenclamide by piroxicam in rats and humans. ( Diwan, PV; Sastry, MS; Satyanarayana, NV, 1992)
" There were 42 cases of metformin-associated lactic acidosis (MALA) with 18 deaths (43%); 40 of the MALA cases had documented contra-indications, especially renal impairment, and the remaining two cases were due to drug overdosage, one being a suicide."	3.67	Metformin and the sulphonylureas: the comparative risk. ( Campbell, IW, 1985)
" The starting dosage for glyburide was 2."	2.87	Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial. ( Affres, H; Beucher, G; Bourcigaux, N; Bouyer, J; Bretelle, F; Castera, V; Cazaubiel, M; Coustols-Valat, M; De Carne, C; Deruelle, P; Desbriere, R; Héron, I; Jacquier, JF; Laboureau, S; Legardeur, H; Letourneau, A; Maillot, F; Mitanchez, D; Morin, M; Rod, A; Rolland, C; Sénat, MV; Sentilhes, L; Simon, E; Verspyck, E, 2018)
"Glyburide was started in 53 patients and metformin in 51."	2.84	Glyburide Versus Metformin and Their Combination for the Treatment of Gestational Diabetes Mellitus: A Randomized Controlled Study. ( Gam Ze Letova, Y; Hasanein, J; Hissin, N; Nachum, Z; Salim, R; Suleiman, A; Yefet, E; Zafran, N, 2017)
"Hypoglycemia was defined as sensor glucose level of less than 60 mg/dl in two or more consecutive readings from CGM."	2.82	Glycemic excursions are positively associated with changes in duration of asymptomatic hypoglycemia after treatment intensification in patients with type 2 diabetes. ( Lee, IT; Lee, WJ; Lin, SD; Lin, SY; Sheu, WH; Su, SL; Tseng, YH; Tu, ST; Wang, JS, 2016)
"Patients with type 2 diabetes (n = 16,492) were randomized to saxagliptin or placebo and followed for a median of 2."	2.82	Predisposing Factors for Any and Major Hypoglycemia With Saxagliptin Versus Placebo and Overall: Analysis From the SAVOR-TIMI 53 Trial. ( Bhatt, DL; Braunwald, E; Cahn, A; Hirshberg, B; Im, K; Iqbal, N; Kanevsky, E; Leibowitz, G; Mosenzon, O; Raz, I; Rozenberg, A; Scirica, BM; Sjostrand, M; Stahre, C; Yanuv, I, 2016)
"In a south Indian population with gestational diabetes, metformin was associated with better neonatal outcomes than glibenclamide."	2.80	Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial. ( Abraham, A; Antonisamy, B; Beck, M; Benjamin, SJ; George, A; Jana, AK; Mathews, JE; Sam, D; Thomas, N, 2015)
"Women with gestational diabetes mellitus were randomly allocated to two insulin and glyburide groups and compared with maternal and neonatal outcome."	2.80	Comparison of glyburide and insulin in women with gestational diabetes mellitus and associated perinatal outcome: a randomized clinical trial. ( Faalpoor, Z; Heidar, Z; Jamali, R; Mirzamoradi, M; Naeiji, Z, 2015)
"HRV response to hypoglycemia is impaired in type 2 diabetic subjects resulting in a higher than expected risk for sudden arrhythmia following mild hypoglycemic episodes."	2.78	Reduced capacity of heart rate regulation in response to mild hypoglycemia induced by glibenclamide and physical exercise in type 2 diabetes. ( Bretzel, RG; Fischer, B; Linn, T; Pilatz, A; Soydan, N; Wagenlehner, F, 2013)
" Adverse event frequency was similar in all treatment groups; reported hypoglycaemia event rates were 24."	2.76	Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks. ( Chacra, AR; Chen, R; List, J; Ravichandran, S; Tan, GH, 2011)
"Alogliptin is a dipeptidyl peptidase-4 inhibitor under investigation for treatment of patients with type 2 diabetes mellitus."	2.74	Coadministration of pioglitazone or glyburide and alogliptin: pharmacokinetic drug interaction assessment in healthy participants. ( Fleck, P; Karim, A; Laurent, A; Mekki, Q; Munsaka, M; Wann, E, 2009)
"One nateglinide/metformin-treated patient experienced a mild hypoglycaemic episode compared with eight episodes in eight patients on glyburide/metformin; one severe episode led to discontinuation."	2.73	Nateglinide, alone or in combination with metformin, is effective and well tolerated in treatment-naïve elderly patients with type 2 diabetes. ( Baron, MA; Gerich, JE; Jean-Louis, L; Marcellari, A; Purkayastha, D; Schwarz, SL, 2008)
"0 mg/metformin (M) 400 mg combination with a G 2."	2.71	Effects of two different glibenclamide dose-strengths in the fixed combination with metformin in patients with poorly controlled T2DM: a double blind, prospective, randomised, cross-over clinical trial. ( Brunetti, P; Gori, M; Pagano, G; Perriello, G; Turco, C, 2004)
"Neonatal hypoglycemia was observed in eight newborns, six of which from the glyburide group."	2.71	Perinatal outcomes and the use of oral hypoglycemic agents. ( Aquim, G; Becker, F; Bertini, AM; Engel Ribeiro, T; Lemos Bebber, FR; Silva, JC; Taborda, W; Zucco Viesi, JM, 2005)
"To evaluate the efficacy and safety of two dosage strengths of a single-tablet metformin-glibenclamide (glyburide) combination, compared with the respective monotherapies, in patients with Type 2 diabetes mellitus (DM) inadequately controlled by metformin monotherapy."	2.70	Improved glycaemic control with metformin-glibenclamide combined tablet therapy (Glucovance) in Type 2 diabetic patients inadequately controlled on metformin. ( Allavoine, T; Howlett, H; Lehert, P; Marre, M, 2002)
" After Ramadan, patients resumed their regular meal pattern and treatment dosage for 4 weeks."	2.70	Repaglinide versus glibenclamide treatment of Type 2 diabetes during Ramadan fasting. ( Mafauzy, M, 2002)
"A total of 84 patients with Type 2 diabetes (fasting blood glucose: 120-180 mg/dl; postprandial blood glucose: 140-240 mg/dl) was included in this two-centre, double-blind, double-dummy, placebo-controlled study."	2.70	The effect of combination treatment with acarbose and glibenclamide on postprandial glucose and insulin profiles: additive blood glucose lowering effect and decreased hypoglycaemia. ( Haupt, E; Rosak, C; Walter, T; Werner, J, 2002)
"Hypoglycemia is the principal barrier to achieving target glucose goals in type 2 diabetes."	2.70	Effect of short-term glucose control on glycemic thresholds for epinephrine and hypoglycemic symptoms. ( Burge, MR; Qualls, CR; Schade, DS; Sobhy, TA, 2001)
"No hypoglycemia was observed during 156 fasting studies."	2.69	A prospective trial of risk factors for sulfonylurea-induced hypoglycemia in type 2 diabetes mellitus. ( Burge, MR; Fischette, C; Qualls, CR; Schade, DS; Schmitz-Fiorentino, K, 1998)
" It is thus appropriate to consider dosing it less frequently."	2.69	Efficacy and safety of single versus multiple daily doses of glibenclamide in type 2 diabetes mellitus. ( Ismail, RB; Mafauzy, M; Tun Fizi, A; Wan Mohamad, WB, 2000)
"Women with gestational diabetes mellitus are rarely treated with a sulfonylurea drug, because of concern about teratogenicity and neonatal hypoglycemia."	2.69	A comparison of glyburide and insulin in women with gestational diabetes mellitus. ( Berkus, MD; Conway, DL; Gonzales, O; Langer, O; Xenakis, EM, 2000)
" Therefore, it is apparent that the addition of glibenclamide to insulin reduces daily insulin dosage and renders a greater uniformity to diurnal blood glucose control, most probably secondary to enhancement of insulin sensitivity."	2.68	More uniform diurnal blood glucose control and a reduction in daily insulin dosage on addition of glibenclamide to insulin in type 1 diabetes mellitus: role of enhanced insulin sensitivity. ( Birkenholz, M; Kabadi, M; Kabadi, UM; McCoy, S, 1995)
"Miglitol monotherapy is effective and safe in NIDDM patients."	2.68	The efficacy and safety of miglitol therapy compared with glibenclamide in patients with NIDDM inadequately controlled by diet alone. ( Berlin, C; Feig, PU; Petzinna, D; Ratzmann, KP; Rybka, J; Schernthaner, G; Segal, P, 1997)
"Glyburide was then stopped, and insulin was continued for 6 wk, aiming for normal FPG (insulin phase)."	2.67	Comparison of morning or bedtime insulin with and without glyburide in secondary sulfonylurea failure. ( Abraira, C; Agrawal, L; Lawrence, AM; Murphy, JC; Soneru, IL, 1993)
"Metformin has also proven to be safe and may be considered as an initial single agent for milder gestational diabetes."	2.55	The care of pregestational and gestational diabetes and drug metabolism considerations. ( Davis, SN; Hedrington, MS, 2017)
"Glyburide has good efficacy and short-term data but it also crosses the placenta and may be associated with increased rates of large-for-gestational-age (LGA) infants and neonatal hypoglycaemia when compared with insulin."	2.55	Pharmacological Management of Gestational Diabetes Mellitus. ( Feig, DS; Mukerji, G, 2017)
" Other oral medications have not been shown to be safe in pregnancy."	2.52	Safety considerations with pharmacological treatment of gestational diabetes mellitus. ( Simmons, D, 2015)
"At short term, in women with gestational diabetes requiring drug treatment, glibenclamide is clearly inferior to both insulin and metformin, while metformin (plus insulin when required) performs slightly better than insulin."	2.52	Glibenclamide, metformin, and insulin for the treatment of gestational diabetes: a systematic review and meta-analysis. ( Balsells, M; Corcoy, R; García-Patterson, A; Gich, I; Roqué, M; Solà, I, 2015)
"In the treatment of elderly type 2 diabetes, it is important to detect hypoglycemia correctly, because the elderly patients often exhibit atypical symptoms from hypoglycemia."	2.43	[Knack of treatment with oral hypoglycemic drugs in the elderly]. ( Hashizume, K; Komatsu, M, 2006)
"Repaglinide is an insulin secretion enhancer with a different mechanism of action to the sulphonylureas, which means it does not continuously stimulate insulin secretion."	2.41	[Repaglinide, potentially a therapeutic improvement for diabetes mellitus type 2]. ( Rutten, GE, 2001)
"The management of diabetes mellitus is often complicated in patients with advanced cancer."	2.40	The management of diabetes in patients with advanced cancer. ( Poulson, J, 1997)
" We compared the effects of three SU medications and initial SU doses on adverse glycemic and cardiovascular events among NH residents."	1.91	Comparative safety of sulfonylureas among U.S. nursing home residents. ( Berry, SD; Hayes, KN; Munshi, MN; Riester, MR; Zullo, AR, 2023)
"Serious hypoglycemia is a major adverse event associated with insulin secretagogues."	1.72	Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia. ( Bilker, WB; Brensinger, CM; Flory, JH; Hee Nam, Y; Hennessy, S; Leonard, CE, 2022)
"Hypoglycemia is common in patients with diabetes."	1.48	Risk of Hypoglycemia Following Hospital Discharge in Patients With Diabetes and Acute Kidney Injury. ( Abdel-Kader, K; Greevy, RA; Griffin, MR; Horner, J; Hung, AM; Ikizler, TA; Matheny, ME; Parr, SK; Perkins, AM; Roumie, CL; Siew, ED; Speroff, T; Wilson, OD, 2018)
" We aimed to systematically screen for drugs that interact with the five most commonly used secretagogues-glipizide, glyburide, glimepiride, repaglinide, and nateglinide-to cause serious hypoglycemia."	1.46	Biomedical Informatics Approaches to Identifying Drug-Drug Interactions: Application to Insulin Secretagogues. ( Bilker, WB; Brensinger, CM; Chiang, C; Han, X; Hennessy, S; Leonard, CE; Li, L, 2017)
"Pasireotide (SOM230) is a multireceptor-targeted somatostatin analogue with a 39-, 30- and 5-fold higher binding affinity for sstr5, sstr1 and sstr3, respectively, and a slightly lower (0."	1.42	Pasireotide (SOM230) prevents sulfonylurea-induced hypoglycemia in rats. ( Schmid, HA, 2015)
"Gliclazide or metformin-treated patients demonstrated lesser mortality risk than glibenclamide-treated ones in all four evaluation models, but age and duration stratification can influence this phenomenon in case of "first prescription model"."	1.40	Evaluation approach can significantly influence oral glucose-lowering drugs total mortality risks in retrospective cohorts of type 2 diabetes mellitus patients. ( Khalangot, M; Kovtun, V, 2014)
"Hypoglycemia was defined as a blood glucose of less than 50 mg/dL, further classified as "severe hypoglycemia" if the event required the assistance of another person for resuscitation, "symptomatic hypoglycemia" if it was associated with typical neurogenic symptoms, or "asymptomatic hypoglycemia" if the biochemical reading was less than 50 mg/dL with no symptoms or accompanied by mild symptoms that did not impair the patient's ability to function."	1.37	Hypoglycemia in glyburide-treated gestational diabetes: is it dose-dependent? ( Brustman, L; El Daouk, M; Fuchs, A; Langer, O; Rosenn, B; Scarpelli, S, 2011)
"The study cohort consisted of type 2 diabetes mellitus patients (n = 80) on regular therapy with glibenclamide either alone or with concomitant metformin."	1.37	Influence of CYP2C9 gene polymorphisms on response to glibenclamide in type 2 diabetes mellitus patients. ( Adithan, C; Agrawal, A; Anichavezhi, D; Pradhan, SC; Rajan, S; Subrahmanyam, DK; Surendiran, A, 2011)
"Hypoglycemia is common after accidental sulfonylurea exposures."	1.37	Hypoglycemia after accidental pediatric sulfonylurea ingestions. ( Burns, BD; Levine, M; Lovecchio, F; Pizon, AF; Riley, BD; Ruha, AM; Thomas, SH, 2011)
"Severe hypoglycemia was defined as a symptomatic event requiring treatment with intravenous glucose and was confirmed by a blood glucose measurement of < 50 mg/dl."	1.36	Severe sulfonylurea-induced hypoglycemia: a problem of uncritical prescription and deficiencies of diabetes care in geriatric patients. ( Hahn, M; Hammer, C; Holstein, A; Kovacs, P; Kulamadayil, NS, 2010)
"A total of 400 patients with type 2 diabetes, who were > or = 35 years old and who had been treated with metformin and a sulphonylurea for at least 6 months, completed questionnaires during their usual primary care office visit."	1.35	Hypoglycaemia in patients with type 2 diabetes treated with a combination of metformin and sulphonylurea therapy in France. ( Krishnarajah, G; Lyu, R; Mavros, P; Vexiau, P; Yin, D, 2008)
"The second woman had serious orthostatic hypotension because of a pharmacodynamic interaction between three different antihypertensives."	1.32	[Adverse drug reactions in three older patients, even without changes in medication]. ( Mannesse, CK; van der Cammen, TJ, 2003)
"An evaluation of 82 patients with gestational diabetes was performed; 30 were insulin-treated, 27 were managed by diet only, and 25 were patients treated with glyburide."	1.32	Undiagnosed asymptomatic hypoglycemia: diet, insulin, and glyburide for gestational diabetic pregnancy. ( Ben-Haroush, A; Chen, R; Hod, M; Langer, O; Rosenn, B; Yogev, Y, 2004)
"Nateglinide (A-4166) is an amino acid derivative with insulinotrophic action in clinical development for treatment of type 2 diabetes."	1.31	Pancreatic beta-cell K(ATP) channel activity and membrane-binding studies with nateglinide: A comparison with sulfonylureas and repaglinide. ( Bell, PA; Boettcher, BR; Dunning, BE; Fanelli, B; Geisse, S; Hu, S; Schmitz, R; Wang, S, 2000)
"We enrolled 340 NIDDM outpatients adjusted for sex, age, body mass index, alcohol intake and oral treatment regimen with glibenclamide."	1.31	Does holiday hypoglycaemia exist? ( D'Anchino, M; Della Loggia, F; Della Vecchia, R; Formisano, S; Guagnano, MT; Merlitti, D; Pace-Palitti, V; Sensi, S, 2000)
"Diazoxide was without effect on tau(open) and tau(closed,fast) but decreased significantly tau(closed,slow) (24."	1.31	Analysis of single K(ATP) channels in mammalian dentate gyrus granule cells. ( Carlen, PL; Pahapill, PA; Pelletier, MR; Pennefather, PS, 2000)
"Hypoglycemia was defined as blood glucose (BG) concentration < 60 mg/dl."	1.30	Prospective multicenter study of sulfonylurea ingestion in children. ( Anderson, BD; Anderson, DL; Fenn, J; Gorman, SE; Krenzelok, EP; Muir, SJ; Rodgers, GC; Rose, SR; Spiller, HA; Villalobos, D, 1997)
"ECG was continuously recorded for arrhythmia-monitoring, and 12-lead ECGs were recorded at T = 0 and 150 min."	1.30	Increased QT dispersion during hypoglycaemia in patients with type 2 diabetes mellitus. ( Adamson, U; Englund, A; Landstedt-Hallin, L; Lins, PE, 1999)
" Old age, maximum dosage of glibenclamide (15 mg/day) and multimorbidity were characteristic of these patients."	1.29	[Incidence of severe hypoglycemia in relation to metabolic control and patient knowledge]. ( Ratzmann, KP; Schimke, E, 1995)
"A Leucodelphinidin derivative isolated from the bark of Ficus bengalensis Linn demonstrated hypoglycemic action at a dosage of 250 mg/kg given both in normal and alloxan diabetic rats."	1.29	Hypoglycemic effects of leucodelphinidin derivative isolated from Ficus bengalensis (Linn). ( Augusti, KT; Geetha, BS; Mathew, BC, 1994)
"A patient with noninsulin-dependent diabetes mellitus (NIDDM) who had previously developed secondary failure while taking a maximal dosage of glipizide was switched to glyburide 5 mg/d."	1.29	Inappropriate use of high-dose glyburide to treat uncontrolled type 2 diabetes mellitus. ( Cook, DD; Ewing, RC; Rae, CE, 1993)
"66% would treat hypoglycemia with oral carbohydrates."	1.28	[Hypoglycemia in type II diabetic patients]. ( Bielefeldt, K; Reis, HE, 1990)
" At the same time about 1/3 of these serious adverse drug reactions (ADR) was found to have been reported to the ADR-register."	1.27	Drug utilization and morbidity statistics for the evaluation of drug safety in Sweden. ( Westerholm, B; Wiholm, BE, 1984)

Research

Studies (310)

Authors

Clinical Trials (13)

Trial Overview

Trial Outcomes

All Reported Hypoglycemic Adverse Events During the ST + LT Treatment Period

Timeframe	Studies, this research(%)	All Research%
pre-1990	85 (27.42)	18.7374
1990's	69 (22.26)	18.2507
2000's	75 (24.19)	29.6817
2010's	72 (23.23)	24.3611
2020's	9 (2.90)	2.80

Authors	Studies
Hernández-Vázquez, E	1
Castañeda-Arriaga, R	1
Ramírez-Espinosa, JJ	1
Medina-Campos, ON	1
Hernández-Luis, F	1
Chaverri, JP	1
Estrada-Soto, S	1
Harrison, RK	1
Saravanan, V	1
Davitt, C	1
Cruz, M	1
Palatnik, A	1
Zullo, AR	2
Riester, MR	2
Hayes, KN	2
Munshi, MN	2
Berry, SD	2
Wang, T	1
Jing, Y	1
Guo, H	1
Xu, J	1
Wang, M	1
Huang, L	1
Chen, H	1
Cui, W	1
Song, L	1
Liu, X	1
Sun, B	2
Wang, N	1
Lawal, SK	1
Adeniji, AA	1
Sulaiman, SO	1
Akajewole, MM	1
Buhari, MO	1
Osinubi, AA	1
Bouchghoul, H	3
Alvarez, JC	1
Verstuyft, C	2
Bouyer, J	5
Senat, MV	5
Saberi, M	1
Ramazani, Z	1
Rashidi, H	1
Saberi, A	1
Affres, H	3
Letourneau, A	3
Deruelle, P	2
Coustols-Valat, M	2
Armahizer, MJ	1
Howard, AK	1
Seung, H	1
Kalasapudi, L	1
Sansur, C	1
Morris, NA	1
Mandelbrot, L	1
Bourcigaux, N	2
Becquemont, L	1
Hee Nam, Y	1
Brensinger, CM	6
Bilker, WB	6
Flory, JH	3
Leonard, CE	5
Hennessy, S	7
Zhou, M	1
Wang, SV	1
Gagne, JJ	3
Fuller, C	1
Hampp, C	1
Archdeacon, P	1
Toh, S	1
Iyer, A	1
Woodworth, TS	1
Cavagnaro, E	1
Panozzo, CA	1
Axtman, S	1
Carnahan, RM	1
Chrischilles, EA	1
Song, R	1
Chen, L	1
Chen, Y	1
Si, X	1
Liu, Y	2
Irwin, DM	1
Feng, W	1
Hedrington, MS	1
Davis, SN	3
Mukerji, G	1
Feig, DS	1
Hung, AM	1
Siew, ED	1
Wilson, OD	1
Perkins, AM	1
Greevy, RA	1
Horner, J	1
Abdel-Kader, K	1
Parr, SK	1
Roumie, CL	1
Griffin, MR	1
Ikizler, TA	1
Speroff, T	1
Matheny, ME	1
Aquilante, CL	1
Boudreau, DM	1
Deo, R	1
Mangaali, MJ	1
Cazaubiel, M	1
Legardeur, H	1
Jacquier, JF	1
Simon, E	1
Rod, A	1
Héron, I	1
Castera, V	1
Sentilhes, L	1
Bretelle, F	1
Rolland, C	1
Morin, M	1
De Carne, C	1
Maillot, F	1
Beucher, G	1
Verspyck, E	1
Desbriere, R	1
Laboureau, S	1
Mitanchez, D	1
Reno, CM	1
Bayles, J	1
Skinner, A	1
Fisher, SJ	1
Steyn, M	1
Couchman, L	1
Coombes, G	1
Earle, KA	1
Johnston, A	1
Holt, DW	1
Farid, TA	1
Bhaskaran, A	1
Nanthakumar, K	1
Welk, B	1
Richard, L	1
Winick-Ng, J	1
Shariff, SZ	1
Clemens, KK	2
Peng, S	1
Li, C	1
Sun, X	1
Kallio-Kujala, IJ	1
Bennett, RC	1
Raekallio, MR	1
Yatkin, E	1
Meierjohann, A	1
Savontaus, E	1
Scheinin, M	2
Spillmann, T	1
Vainio, OM	1
Mathews, JE	2
Biswas, B	1
Samuel, P	1
Jana, AK	2
Muliyil, JP	1
Mathai, M	1
Barkin, JA	1
Block, HM	1
Mendez, PE	1
Süfke, S	1
Steinhoff, J	1
Schütt, M	1
Karyekar, CS	1
Frederich, R	1
Ravichandran, S	2
Holstein, A	6
Kovacs, P	2
Beil, W	1
Lamos, EL	1
Stein, SA	1
Sheth, KN	1
Kimberly, WT	1
Elm, JJ	1
Kent, TA	1
Mandava, P	1
Yoo, AJ	1
Thomalla, G	1
Campbell, B	1
Donnan, GA	1
Davis, SM	1
Albers, GW	1
Jacobson, S	1
Simard, JM	1
Stern, BJ	1
Schelleman, H	2
Han, X	3
Quinney, SK	1
Flockhart, DA	2
Li, L	2
Tan, A	3
Holmes, HM	1
Kuo, YF	2
Raji, MA	1
Goodwin, JS	2
Parekh, TM	1
Raji, M	1
Lin, YL	1
Khalangot, M	1
Kovtun, V	1
Simmons, D	1
Balsells, M	1
García-Patterson, A	1
Solà, I	1
Roqué, M	1
Gich, I	1
Corcoy, R	1
Schmid, HA	1
George, A	2
Sam, D	1
Beck, M	1
Benjamin, SJ	1
Abraham, A	1
Antonisamy, B	1
Thomas, N	1
Mirzamoradi, M	1
Heidar, Z	1
Faalpoor, Z	1
Naeiji, Z	1
Jamali, R	1
Kuramoto, N	1
Yabe, D	2
Kurose, T	1
Seino, Y	2
Joy, NG	1
Tate, DB	1
McArthur, E	1
Dixon, SN	1
Fleet, JL	1
Hramiak, I	1
Garg, AX	2
Ruohonen, ST	1
Ranta-Panula, V	1
Bastman, S	1
Chrusciel, P	1
Streng, T	1
Chan, SP	1
Colagiuri, S	1
Glover, AV	1
Tita, A	1
Biggio, JR	1
Harper, LM	1
Cardillo, S	1
Wang, JS	1
Lee, IT	1
Lee, WJ	1
Lin, SD	1
Su, SL	1
Tu, ST	1
Tseng, YH	1
Lin, SY	1
Sheu, WH	1
Kuwata, H	1
Cahn, A	1
Raz, I	1
Mosenzon, O	1
Leibowitz, G	1
Yanuv, I	1
Rozenberg, A	1
Iqbal, N	1
Hirshberg, B	1
Sjostrand, M	1
Stahre, C	1
Im, K	1
Kanevsky, E	1
Scirica, BM	1
Bhatt, DL	1
Braunwald, E	1
Eriksson, JW	1
Bodegard, J	1
Nathanson, D	1
Thuresson, M	1
Nyström, T	1
Norhammar, A	1
Bosco-Lévy, P	1
Salvo, F	1
Romley, JA	1
Gong, C	1
Jena, AB	1
Goldman, DP	1
Williams, B	1
Peters, A	1
Hashimoto, Y	1
Dateki, S	1
Hirose, M	1
Satomura, K	1
Sawada, H	1
Mizuno, H	1
Sugihara, S	1
Maruyama, K	1
Urakami, T	1
Sugawara, H	1
Shirai, K	1
Yorifuji, T	1
Nachum, Z	1
Zafran, N	1
Salim, R	1
Hissin, N	1
Hasanein, J	1
Gam Ze Letova, Y	1
Suleiman, A	1
Yefet, E	1
Brown, J	1
Martis, R	1
Hughes, B	1
Rowan, J	1
Crowther, CA	1
Chiang, C	1
Tayek, J	1
Lim, CC	2
Gan, R	1
Chan, CL	2
Tan, AW	1
Khoo, JJ	1
Chia, SY	1
Kao, SL	2
Abisheganaden, J	1
Sitoh, YY	1
De Mattia, G	1
Laurenti, O	1
Moretti, A	1
Dalan, R	2
Leow, MK	1
George, J	1
Chian, KY	1
Han, HW	1
Cheow, SP	1
Glatstein, M	2
Garcia-Bournissen, F	2
Scolnik, D	2
Koren, G	3
Finkelstein, Y	1
Tan, B	1
Gardner, D	1
Pratt, E	1
Lee, M	1
Lee, KO	1
Milicevic, Z	3
Hancu, N	1
Car, N	1
Ivanyi, T	1
Schwarzenhofer, M	2
Jermendy, G	1
Poon, WT	1
Lam, YH	1
Lee, HH	1
Ching, CK	1
Chan, WT	1
Chan, SS	1
Lai, CK	1
Tse, ML	1
Chan, AY	1
Mak, TW	1
Udayakumar, R	1
Kasthurirengan, S	1
Mariashibu, TS	1
Rajesh, M	1
Anbazhagan, VR	1
Kim, SC	1
Ganapathi, A	1
Choi, CW	1
Karim, A	1
Laurent, A	1
Munsaka, M	1
Wann, E	1
Fleck, P	1
Mekki, Q	1
McGill, JB	1
Chan, TY	4
Greco, D	2
Pisciotta, M	1
Gambina, F	1
Maggio, F	1
Carles, G	1
Germain, L	1
Alassas, N	1
El Guindi, W	1
Dallah, F	1
Daigre, JL	1
Böhm, R	1
Cascorbi, I	1
Herdegen, T	1
Silva, JC	2
Pacheco, C	1
Bizato, J	1
de Souza, BV	1
Ribeiro, TE	1
Bertini, AM	2
Hammer, C	2
Hahn, M	1
Kulamadayil, NS	1
Chaubey, SK	1
Sangla, KS	1
Suthaharan, EN	1
Tan, YM	1
Wan, F	1
Fasano, CJ	1
Rowden, AK	1
O'Malley, GF	1
Aguilera, E	1
Heard, K	1
Weir, MA	1
Gomes, T	1
Mamdani, M	2
Juurlink, DN	2
Hackam, DG	1
Mahon, JL	1
Jain, AK	1
Sutin, DG	1
Brustman, L	1
Langer, O	3
Scarpelli, S	1
El Daouk, M	1
Fuchs, A	1
Rosenn, B	2
Geisler, SA	1
Felisberto-Junior, AM	1
Tavoni, TM	1
Carrara, MA	1
Curi, R	1
Bazotte, RB	1
Surendiran, A	1
Pradhan, SC	1
Agrawal, A	1
Subrahmanyam, DK	1
Rajan, S	1
Anichavezhi, D	1
Adithan, C	1
Ramos, GA	1
Hanley, AA	1
Aguayo, J	1
Warshak, CR	1
Kim, JH	1
Moore, TR	1
Chacra, AR	1
Tan, GH	1
List, J	1
Chen, R	2
Spellacy, WN	1
Levine, M	1
Ruha, AM	1
Lovecchio, F	1
Riley, BD	1
Pizon, AF	1
Burns, BD	1
Thomas, SH	1
Lung, DD	1
Gerona, RR	1
Wu, AH	1
Smollin, CG	1
Skoff, RA	1
Waterbury, NV	1
Shaw, RF	1
Egge, JA	1
Cantrell, M	1
Miller, DK	1
Brinson, AJ	1
Catalano, G	1
Catalano, MC	1
Deusenberry, CM	1
Coley, KC	1
Korytkowski, MT	1
Donihi, AC	1
Soydan, N	1
Bretzel, RG	1
Fischer, B	1
Wagenlehner, F	1
Pilatz, A	1
Linn, T	2
Marre, M	2
Howlett, H	2
Lehert, P	2
Allavoine, T	2
Mafauzy, M	2
Rosak, C	1
Haupt, E	1
Walter, T	1
Werner, J	1
Bussing, R	1
Gende, A	1
Trenque, T	2
Frances, C	1
Millart, H	1
Hoizey, G	2
Germain, ML	1
Scannapieco, G	1
Franzoso, F	1
Grasso, M	1
Kopp, A	1
Laupacis, A	1
Redelmeier, DA	1
Garber, A	2
Blonde, L	1
Cornes, M	1
Plaschke, A	2
Egberts, EH	3
Mannesse, CK	1
van der Cammen, TJ	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes[NCT01731431]	Phase 3	914 participants (Actual)	Interventional	2012-05-18	Completed
"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"[NCT00121667]	Phase 3	1,462 participants (Actual)	Interventional	2005-08-31	Completed
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control[NCT00295633]	Phase 3	565 participants (Actual)	Interventional	2006-03-31	Completed
A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects[NCT00327015]	Phase 3	1,306 participants (Actual)	Interventional	2006-05-31	Completed
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone[NCT00313313]	Phase 3	768 participants (Actual)	Interventional	2006-04-30	Completed
A Multi-Center, Prospective, Open Label, Phase IIa Trial of RP-1127 (Glyburide for Injection) in Patients With a Severe Anterior Circulation Ischemic Stroke Who Are Likely to Experience Clinically Significant Brain Swelling.[NCT01268683]	Phase 1/Phase 2	10 participants (Actual)	Interventional	2011-05-26	Completed
Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study[NCT03000283]	Phase 1	7 participants (Actual)	Interventional	2017-03-22	Completed
Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. A Systematic Review and Meta-analysis of Randomized Controlled Trials Comparing These Drugs Either vs Insulin or vs Each Other.[NCT01998113]		2,509 participants (Actual)	Observational	2013-03-31	Completed
Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial[NCT06064669]		988 participants (Anticipated)	Interventional	2023-10-01	Not yet recruiting
[NCT01563120]	Phase 4	108 participants (Actual)	Interventional	2012-01-31	Completed
Transversal, Multicentric Study for Early Detection of Drug Interactions in Older Hospitalized Patients Using on Line Software in Córdoba, Argentina[NCT00850330]		3,000 participants (Anticipated)	Observational	2009-06-30	Recruiting
Predicting Hypoglycaemia and Arrhythmias in the Vulnerable Patient With Diabetes and Chronic Kidney Disease - Validation Study[NCT02778269]		7 participants (Actual)	Interventional	2016-06-30	Completed
Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. ACARB-GDM Study.[NCT03380546]	Phase 3	341 participants (Actual)	Interventional	2018-07-04	Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which are hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. (NCT00121667)
Timeframe: AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla

Confirmed Hypoglycemia During the ST + LT Treatment Period

Intervention	participants (Number)
Saxagliptin 2.5 mg + Metformin	23
Saxagliptin 5 mg + Metformin	20
Saxagliptin 10 mg + Metformin	21
Placebo+ Metformin	20

'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick glucose <= 50 mg/dL and associated symptoms. (NCT00121667)
Timeframe: AEs: up to last treatment day + 1 day or last visit day in the ST+LT period; SAEs: up to last treatment day + 30 days or last visit day + 30 days in the LT+ST period. Mean duration of exposure: 124, 118, 130, 95 wks respectively for 2.5mg, 5mg, 10 mg, pla

Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24

Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)

Intervention	participants (Number)
Saxagliptin 2.5 mg + Metformin	3
Saxagliptin 5 mg + Metformin	2
Saxagliptin 10 mg + Metformin	3
Placebo+ Metformin	1

Intervention	percentage of participants (Number)
Saxagliptin 2.5 mg + Metformin	37.1
Saxagliptin 5 mg + Metformin	43.5
Saxagliptin 10 mg + Metformin	44.4
Placebo+ Metformin	16.6

Mean change from baseline is adjusted for baseline value. (NCT00121667)
Timeframe: Baseline, Week 24

Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Intervention	mg*min/dL (Mean)
	Baseline Mean	Adjusted Mean Change from Baseline
Placebo+ Metformin	47407	-3291
Saxagliptin 10 mg + Metformin	44931	-8137
Saxagliptin 2.5 mg + Metformin	48224	-8891
Saxagliptin 5 mg + Metformin	49021	-9586

Mean change from baseline is adjusted for baseline value. (NCT00121667)
Timeframe: Baseline, Week 24

Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24

Intervention	mg/dL (Mean)
	Baseline Mean	Adjusted Mean Change from Baseline
Placebo+ Metformin	174.94	1.24
Saxagliptin 10 mg + Metformin	175.86	-20.50
Saxagliptin 2.5 mg + Metformin	173.57	-14.31
Saxagliptin 5 mg + Metformin	179.03	-22.03

Mean change from baseline is adjusted for baseline value. (NCT00121667)
Timeframe: Baseline, Week 24

Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period

Intervention	percentage of glycosylated hemoglobins (Mean)
	Baseline Mean	Adjusted Mean Change from Baseline
Placebo+ Metformin	8.06	0.13
Saxagliptin 10 mg + Metformin	7.98	-0.58
Saxagliptin 2.5 mg + Metformin	8.08	-0.59
Saxagliptin 5 mg + Metformin	8.07	-0.69