carbon monoxide has been researched along with Diabetes Mellitus, Adult-Onset in 20 studies
Carbon Monoxide: Carbon monoxide (CO). A poisonous colorless, odorless, tasteless gas. It combines with hemoglobin to form carboxyhemoglobin, which has no oxygen carrying capacity. The resultant oxygen deprivation causes headache, dizziness, decreased pulse and respiratory rates, unconsciousness, and death. (From Merck Index, 11th ed)
carbon monoxide : A one-carbon compound in which the carbon is joined only to a single oxygen. It is a colourless, odourless, tasteless, toxic gas.
| Excerpt | Relevance | Reference |
|---|---|---|
| " Cough was the most common adverse event; however, there was no difference in incidence between the AIR insulin (15." | 2.74 | Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: A 12-month, randomized, noninferiority trial. ( Ang, E; Berclaz, PY; Ferguson, JA; Heilmann, CR; Lawrence, MK; Tobian, JA; Webb, DM, 2009) |
| " Adverse events were comparable, except for a higher incidence of mild cough and dyspnea with EXU." | 2.73 | Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. ( Belanger, A; Cefalu, WT; Duggan, WT; Eliaschewitz, FG; Foyt, H; Gross, JL; Hollander, PA; Klioze, SS; Ogawa, M; Rosenstock, J; St Aubin, LB, 2008) |
| "The presence of diabetic nephropathy was determined by 24 h protein excretion." | 1.32 | Pulmonary functions in patients with type 2 diabetes mellitus & correlation with anthropometry & microvascular complications. ( Guleria, R; Misra, A; Pandey, RM; Sinha, S; Tiwari, S; Yadav, R, 2004) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 1 (5.00) | 18.2507 |
| 2000's | 8 (40.00) | 29.6817 |
| 2010's | 9 (45.00) | 24.3611 |
| 2020's | 2 (10.00) | 2.80 |
| Authors | Studies |
|---|---|
| Gurudatta Pawar, S | 1 |
| K, A | 1 |
| Santhanam, J | 1 |
| Nellaiappa Ganesan, SK | 1 |
| Vidya, TA | 1 |
| Kumarasamy, S | 1 |
| Meenakshi Sundari, SN | 1 |
| Ramya, SG | 1 |
| Bahadoran, Z | 1 |
| Mirmiran, P | 1 |
| Kashfi, K | 1 |
| Ghasemi, A | 1 |
| Mohammed Al-Amily, I | 1 |
| Lundquist, I | 2 |
| Salehi, A | 2 |
| Huang, Z | 1 |
| Liu, Y | 2 |
| Mao, Y | 1 |
| Chen, W | 1 |
| Xiao, Z | 1 |
| Yu, Y | 1 |
| Song, J | 1 |
| Zheng, L | 1 |
| Gui, L | 1 |
| Zhao, X | 1 |
| Xu, D | 1 |
| Wu, W | 1 |
| Mukherjee, S | 1 |
| Dey, SG | 1 |
| Mishra, M | 1 |
| Ndisang, JF | 2 |
| Tiwari, S | 2 |
| Wang, Y | 1 |
| Ying, L | 1 |
| Chen, YY | 1 |
| Shen, YL | 1 |
| Guo, R | 1 |
| Jin, KK | 1 |
| Wang, LX | 1 |
| Rosenstock, J | 1 |
| Cefalu, WT | 1 |
| Hollander, PA | 1 |
| Belanger, A | 1 |
| Eliaschewitz, FG | 1 |
| Gross, JL | 1 |
| Klioze, SS | 1 |
| St Aubin, LB | 1 |
| Foyt, H | 1 |
| Ogawa, M | 1 |
| Duggan, WT | 1 |
| Ang, E | 1 |
| Lawrence, MK | 1 |
| Heilmann, CR | 1 |
| Ferguson, JA | 1 |
| Tobian, JA | 1 |
| Webb, DM | 1 |
| Berclaz, PY | 1 |
| Jimenez-Feltstrom, J | 1 |
| Meidute Abaraviciene, S | 1 |
| Henningsson, R | 1 |
| Gui, SL | 1 |
| Cao, HF | 1 |
| Ma, HB | 1 |
| Chi, BJ | 1 |
| Teng, F | 1 |
| Guo, YG | 1 |
| Wang, SQ | 1 |
| Qin, WB | 1 |
| Masmoudi, K | 1 |
| Choyakh, F | 1 |
| Zouari, N | 1 |
| Virtue, MA | 1 |
| Furne, JK | 1 |
| Nuttall, FQ | 1 |
| Levitt, MD | 1 |
| Sinha, S | 1 |
| Guleria, R | 1 |
| Misra, A | 1 |
| Pandey, RM | 1 |
| Yadav, R | 1 |
| Dunn, C | 1 |
| Curran, MP | 1 |
| Chance, WW | 1 |
| Rhee, C | 1 |
| Yilmaz, C | 1 |
| Dane, DM | 1 |
| Pruneda, ML | 1 |
| Raskin, P | 1 |
| Hsia, CC | 1 |
| Paredi, P | 1 |
| Biernacki, W | 1 |
| Invernizzi, G | 1 |
| Kharitonov, SA | 1 |
| Barnes, PJ | 1 |
| Ismail, AA | 1 |
| Gill, GV | 1 |
| Lawton, K | 1 |
| Houghton, GM | 1 |
| MacFarlane, IA | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Efficacy and Safety of Exubera® (Inhaled Insulin) Compared With Subcutaneous Human Insulin Therapy in Adult Subjects With Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial[NCT00136916] | Phase 3 | 635 participants (Actual) | Interventional | 2002-06-30 | Terminated (stopped due to See termination reason in detailed description.) | ||
| A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma[NCT00157339] | Phase 3 | 299 participants (Actual) | Interventional | 2005-08-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3
| Intervention | kg (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=314, 302) | W4 (n=280, 270) | W8 (n=289, 281) | M3 (n=288, 290) | W18(n=280, 285) | M6 (n=276, 277) | M9 (n=269, 274) | M12 (n=259, 264) | M15(n=247, 249) | M18(n=237, 235) | M21(n=232, 232) | M24 (n=223, 226) | FU M3 (n=249, 231) | FU M6 (n=243, 218) | Ext M1 (n=161, 162) | Ext M3 (n=157, 157) | Ext M6 (n=148, 159) | Ext M9 (n=144, 156) | Ext M12 (n=144, 156) | Ext M15 (n=142, 145) | Ext M18 (n=135, 139) | Ext M21(n=132, 143) | Ext M24 (n=126, 131) | Ext M27(n=125, 125) | Ext M30 (n=125, 126) | Ext M33(n=99, 113) | Ext M36 (n=54, 60) | Ext FU M3 (n=119, 115) | |
| Inhaled Insulin (Exubera®) | 87.18 | 0.63 | 1.07 | 1.08 | 1.33 | 1.15 | 1.50 | 1.75 | 1.88 | 1.79 | 1.99 | 2.04 | 2.32 | 2.38 | 2.87 | 2.83 | 3.15 | 2.95 | 2.96 | 3.12 | 3.33 | 2.79 | 2.94 | 2.99 | 3.39 | 2.77 | 2.48 | 2.74 |
| Subcutaneous Insulin | 88.31 | 0.83 | 1.00 | 1.13 | 1.76 | 1.89 | 2.15 | 2.37 | 2.62 | 2.93 | 3.04 | 3.36 | 3.63 | 4.09 | 3.75 | 4.14 | 4.01 | 3.89 | 4.19 | 4.54 | 4.46 | 5.01 | 4.57 | 5.58 | 4.78 | 5.22 | 5.28 | 4.44 |
Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3
| Intervention | ml/min/mmHg (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=308, 303) | M3 (n=289, 290) | M6 (n=278, 280) | M9 (n=266, 272) | M12 (n=258, 263) | M15 (n=246, 248) | M18 (n=237, 232) | M21 (n=231, 231) | M24 (n=221, 223) | FU M1 (n=247, 220) | FU M3 (n=247, 231) | FU M6 (n=241, 219) | Ext M1 (n=159, 161) | Ext M3 (n=157, 157) | Ext M6 (n=148, 157) | Ext M9 (n=143, 155) | Ext M12 (n=141, 155) | Ext M15 (n=141, 142) | Ext M18 (n=132, 138) | Ext M21 (n=129, 142) | Ext M24 (n=124, 130) | Ext M27 (n=123, 124) | Ext M30 (n=124, 125) | Ext M33 (n=98, 113) | Ext M36 (n=52, 60) | Ext M36 [LOCF] (n=171, 169) | Ext FU M3 (n=118, 114) | |
| Inhaled Insulin (Exubera®) | 24.13 | -0.57 | -0.56 | -0.67 | -0.72 | -0.81 | -0.86 | -0.89 | -0.74 | -0.46 | -0.58 | -0.64 | -1.01 | -1.07 | -1.48 | -1.15 | -1.49 | -1.49 | -1.54 | -1.33 | -1.39 | -1.35 | -1.75 | -1.47 | -1.22 | -1.39 | -1.12 |
| Subcutaneous Insulin | 23.97 | -0.32 | -0.44 | -0.72 | -0.41 | -0.56 | -0.65 | -0.67 | -0.81 | -1.02 | -0.90 | -0.95 | -1.09 | -1.16 | -1.26 | -1.36 | -1.59 | -1.46 | -1.63 | -1.64 | -1.46 | -1.44 | -1.62 | -1.61 | -1.87 | -1.77 | -1.69 |
Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3
| Intervention | mg/dL (Mean) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=315, 303) | W6 (n=282, 276) | M3 (n=294, 290) | M6 (n=281, 285) | M9 (n=267, 279) | M12 (n=260, 263) | M15(n=253, 255) | M18(n=242, 238) | M21(n=232, 237) | M24 (n=226, 232) | FU M3 (n=5, 4) | FU M6 (n=161, 156) | Ext M1 (n=165, 162) | Ext M3 (n=162, 159) | Ext M6 (n=152, 161) | Ext M9 (n=149, 155) | Ext M12 (n=148, 155) | Ext M15(n=143, 143) | Ext M18 (n=136, 138) | Ext M21(n=132, 144) | Ext M24 (n=129, 136) | Ext M27 (n=128, 129) | Ext M30 (n=127, 130) | Ext M33(n=103, 115) | Ext M36 (n=55, 64) | Ext FU M3 (n=115, 118) | |
| Inhaled Insulin (Exubera®) | 158.13 | -23.36 | -26.38 | -25.21 | -26.68 | -20.55 | -21.37 | -24.52 | -25.95 | -24.02 | -22.60 | -2.85 | -17.91 | -18.16 | -15.65 | -13.99 | -12.53 | -6.88 | -17.23 | -12.86 | -14.45 | -21.68 | -11.80 | -16.26 | -28.61 | -2.87 |
| Subcutaneous Insulin | 154.53 | -12.55 | -12.77 | -9.05 | -10.41 | -7.60 | -8.82 | -7.69 | -13.14 | -8.91 | -4.08 | -1.56 | -7.34 | -9.29 | -4.34 | -6.06 | -4.98 | -4.23 | -10.32 | -6.53 | -3.47 | -3.76 | -6.40 | -7.35 | -13.35 | 1.88 |
Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3
| Intervention | L (Mean) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=311, 304) | Month 3 (M3) (n=290, 291) | M6 (n=281, 280) | M9 (n=266, 276) | M12 (n=259, 263) | M15 (n=247, 250) | M18 (n=237, 236) | M21 (n=232, 233) | M24 (n=223, 226) | Follow-up (FU) M1 (n=249, 221) | FU M3 (n=248, 231) | FU M6 (n=242, 220) | Extension (Ext) M1 (n=161, 163) | Ext M3 (n=157, 158) | Ext M6 (n=148, 159) | Ext M9 (n=144, 157) | Ext M12 (n=144, 157) | Ext M15 (n=141, 145) | Ext M18 (n=135, 139) | Ext M21 (n=132, 143) | Ext M24 (n=125, 131) | Ext M27 (n=124, 125) | Ext M30 (n=125, 126) | Ext M33 (n=98, 113) | Ext M36 (n=54, 60) | Ext M36 [LOCF] (n=171, 169) | Ext FU M3 (n=119, 115) | |
| Inhaled Insulin (Exubera®) | 2.91 | -0.06 | -0.05 | -0.08 | -0.09 | -0.12 | -0.12 | -0.13 | -0.15 | -0.14 | -0.13 | -0.12 | -0.16 | -0.19 | -0.20 | -0.19 | -0.20 | -0.22 | -0.22 | -0.23 | -0.24 | -0.25 | -0.24 | -0.24 | -0.25 | -0.24 | -0.24 |
| Subcutaneous Insulin | 2.93 | -0.01 | -0.05 | -0.07 | -0.07 | -0.09 | -0.10 | -0.11 | -0.13 | -0.14 | -0.14 | -0.15 | -0.16 | -0.16 | -0.17 | -0.16 | -0.18 | -0.21 | -0.21 | -0.21 | -0.23 | -0.24 | -0.23 | -0.24 | -0.28 | -0.24 | -0.25 |
Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value). (NCT00136916)
Timeframe: Baseline through extension follow up Month 3
| Intervention | percent (Mean) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=315, 303) | Week 6 (W6) (n=291, 280) | M3 (n=296, 291) | M6 (n=284, 287) | M9 (n=270, 280) | M12 (n=261, 263) | M15(n=252, 258) | M18(n=244, 241) | M21 (n=236, 238) | M24 (n=226, 234) | FU M3 (n=225, 226) | FU M6 (n=230, 230) | Ext M1 (n=167, 162) | Ext M3 (n=164, 162) | Ext M6 (n=157, 163) | Ext M9 (n=152, 157) | Ext M12 (n=150, 157) | Ext M15(n=146, 151) | Ext M18 (n=145, 145) | Ext M21(n=137, 147) | Ext M24 (n=131, 137) | Ext M27(n=129, 132) | Ext M30 (n=129, 129) | Ext M33(n=104, 116) | Ext M36 (n=55, 64) | Ext FU M3 (n=117, 116) | |
| Inhaled Insulin (Exubera®) | 7.66 | -0.64 | -0.80 | -0.67 | -0.56 | -0.45 | -0.43 | -0.42 | -0.43 | -0.35 | -0.41 | -0.27 | -0.41 | -0.33 | -0.26 | -0.11 | -0.08 | -0.17 | -0.20 | -0.13 | -0.18 | -0.18 | -0.20 | 8.54 | -0.20 | -0.11 |
| Subcutaneous Insulin | 7.77 | -0.60 | -0.73 | -0.68 | -0.61 | -0.58 | -0.51 | -0.53 | -0.52 | -0.48 | -0.44 | -0.31 | -0.40 | -0.42 | -0.40 | -0.26 | -0.17 | -0.25 | -0.29 | -0.20 | -0.23 | -0.28 | -0.30 | -0.18 | -0.30 | -0.17 |
"Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. No response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn)." (NCT00136916)
Timeframe: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
| Intervention | participants (Number) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M12 = Yes | M12 = No | M12 = No (NSC) | M12 = No (> Abn) | M12 = No (< Abn) | M24 = Yes | M24 = No | M24 = No (NSC) | M24 = No (> Abn) | M24 = No (< Abn) | Ext M6 = Yes | Ext M6 = No | Ext M6 = No (NSC) | Ext M6 = No (> Abn) | Ext M6 = No (< Abn) | Ext M18 = Yes | Ext M18 = No | Ext M18 = No (NSC) | Ext M18 = No (> Abn) | Ext M18 = No (< Abn) | Ext M24 = Yes | Ext M24 = No | Ext M24 = No (NSC) | Ext M24 = No (> Abn) | Ext M24 = No (< Abn) | |
| Inhaled Insulin (Exubera®) | 6 | 20 | 19 | 0 | 1 | 4 | 17 | 17 | 0 | 0 | 3 | 16 | 15 | 1 | 0 | 3 | 14 | 12 | 1 | 1 | 5 | 9 | 8 | 1 | 0 |
| Subcutaneous Insulin | 5 | 16 | 11 | 2 | 3 | 6 | 9 | 8 | 1 | 0 | 3 | 9 | 8 | 1 | 0 | 2 | 7 | 7 | 0 | 0 | 2 | 8 | 8 | 0 | 0 |
Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline. (NCT00136916)
Timeframe: Baseline, M12, M24, Ext M6, Ext M18, Ext M36
| Intervention | participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| M12 = Yes | M12 = No | M24 = Yes | M24 = No | Ext M6 = Yes | Ext M6 = No | Ext M18 = Yes | Ext M18 = No | Ext M36 = Yes | Ext M36 = No | |
| Inhaled Insulin (Exubera®) | 67 | 4 | 38 | 8 | 32 | 8 | 28 | 8 | 22 | 6 |
| Subcutaneous Insulin | 64 | 12 | 51 | 10 | 37 | 8 | 33 | 6 | 27 | 4 |
Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval). (NCT00136916)
Timeframe: Month 1 through extension Month 36
| Intervention | event rate (events/subject months) (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M1 (n=315, 303) | M2 (n=307, 302) | M3 (n=297, 298) | M4 (n=289, 295) | M5 (n=284, 293) | M6 (n=283, 290) | M7 (n=280, 289) | M8 (n=276, 288) | M9 (n=275, 287) | M10 (n=273, 285) | M11 (n=267, 274) | M12 (n=264, 274) | M13 (n=263, 269) | M14 (n=260, 265) | M15 (n=256, 265) | M16 (n=254, 261) | M17 (n=252, 257) | M18 (n=246, 253) | M19 (n=245, 252) | M20 (n=242, 249) | M21 (n=241, 246) | M22 (n=236, 244) | M23 (n=236, 241) | M24 (n=229, 232) | Ext M1 (n=172, 169) | Ext M2 (n=171, 169) | Ext M3 (n=169, 169) | Ext M4 (n=167, 169) | Ext M5 (n=165, 168) | Ext M6 (n=162, 167) | Ext M7 (n=161, 167) | Ext M8 (n=158, 164) | Ext M9 (n=158, 164) | Ext M10 (n=156, 164) | Ext M11 (n=153, 164) | Ext M12 (n=152, 162) | Ext M13 (n=152, 160) | Ext M14 (n=151, 159) | Ext M15 (n=149, 156) | Ext M16 (n=149, 156) | Ext M17 (n=148, 154) | Ext M18 (n=146, 154) | Ext M19 (n=143, 152) | Ext M20 (n=142, 152) | Ext M21 (n=141, 151) | Ext M22 (n=141, 149) | Ext M23 (n=139, 149) | Ext M24 (n=138, 147) | Ext M25 (n=137, 146) | Ext M26 (n=137, 145) | Ext M27 (n=137, 141) | Ext M28 (n=135, 137) | Ext M29 (n=135, 137) | Ext M30 (n=133, 137) | Ext M31 (n=124, 133) | Ext M32 (n=117, 125) | Ext M33 (n=100, 117) | Ext M34 (n=84, 90) | Ext M35 (n=66, 78) | Ext M36 (n=51, 60) | Overall comparative (n=315, 303) | Overall extension (n=172, 169) | |
| Inhaled Insulin (Exubera®) | 1.63 | 1.40 | 1.22 | 1.10 | 0.95 | 0.98 | 0.80 | 0.82 | 0.71 | 0.72 | 0.68 | 0.72 | 0.71 | 0.62 | 0.64 | 0.68 | 0.53 | 0.61 | 0.59 | 0.62 | 0.57 | 0.44 | 0.41 | 0.45 | 1.16 | 1.10 | 1.02 | 0.87 | 0.91 | 0.87 | 1.10 | 0.82 | 0.56 | 0.99 | 0.70 | 1.26 | 1.07 | 0.95 | 0.86 | 0.99 | 1.20 | 1.08 | 1.25 | 1.20 | 0.78 | 0.79 | 0.82 | 0.88 | 0.73 | 0.68 | 0.62 | 0.68 | 0.81 | 0.64 | 0.67 | 0.82 | 0.55 | 0.64 | 0.63 | 0.72 | 0.95 | 0.89 |
| Subcutaneous Insulin | 1.80 | 1.60 | 1.65 | 1.64 | 1.28 | 1.09 | 1.12 | 0.94 | 0.86 | 0.93 | 0.79 | 0.94 | 0.82 | 0.87 | 0.78 | 0.97 | 0.82 | 0.95 | 0.78 | 0.73 | 0.65 | 0.72 | 0.82 | 0.66 | 1.16 | 1.33 | 1.12 | 1.44 | 1.18 | 1.20 | 1.41 | 1.34 | 1.25 | 1.11 | 0.92 | 1.25 | 1.14 | 1.01 | 1.25 | 1.23 | 1.01 | 1.05 | 1.21 | 1.08 | 1.15 | 1.08 | 1.06 | 1.11 | 1.22 | 1.25 | 1.04 | 0.87 | 0.91 | 0.87 | 1.32 | 0.81 | 0.89 | 0.57 | 0.80 | 0.47 | 1.19 | 1.10 |
Observed values for insulin antibodies measured as micro units per milliliter (microU/mL). (NCT00136916)
Timeframe: Baseline through extension Month 36
| Intervention | microU/mL (Median) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=312, 300) | W3 (n=270, 264) | W6 (n=289, 282) | M3 (n=293, 289) | W18 (n=275, 280) | M6 (n=276, 279) | M9 (n=267, 277) | M12 (n=263, 263) | M15 (n=252, 253) | M18 (n=241, 239) | M21 (n=234, 233) | M24 (n=226, 233) | FU M1 (n=247, 226) | FU M3 (n=249, 229) | FU M6 (n=250, 227) | Ext M1 (n=165, 160) | Ext M3 (n=159, 158) | Ext M6 (n=157, 156) | Ext M9 (n=150, 157) | Ext M12 (n=148, 154) | Ext M15 (n=144, 147) | Ext M18 (n=140, 144) | Ext M21 (n=136, 145) | Ext M24 (n=130, 135) | Ext M27 (n=129, 131) | Ext M30 (n=125, 127) | Ext M33 (n=103, 114) | Ext M36 (n=56, 63) | |
| Inhaled Insulin (Exubera®) | 1.05 | 1.05 | 4.40 | 12.00 | 18.00 | 20.00 | 22.00 | 19.00 | 20.00 | 20.00 | 19.00 | 20.00 | 14.00 | 8.50 | 6.55 | 13.00 | 15.00 | 12.00 | 11.50 | 13.00 | 10.50 | 13.00 | 12.00 | 10.50 | 12.00 | 8.40 | 9.20 | 5.75 |
| Subcutaneous Insulin | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 1.05 | 2.50 | 1.05 | 1.05 | 1.05 |
Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval. (NCT00136916)
Timeframe: Month 1 through extension Month 36
| Intervention | event rate (events/subject months*100) (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M1 (n=315, 303) | M2 (n=307, 302) | M3 (n=297, 298) | M4 (n=289, 295) | M5 (n=284, 293) | M6 (n=283, 290) | M7 (n=280, 289) | M8 (n=276, 288) | M9 (n=275, 287) | M10 (n=273, 285) | M11 (n=267, 274) | M12 (n=264, 274) | M13 (n=263, 269) | M14 (n=260, 265) | M15 (n=256, 265) | M16 (n=254, 261) | M17 (n=252, 257) | M18 (n=246, 253) | M19 (n=245, 252) | M20 (n=242, 249) | M21 (n=241, 246) | M22 (n=236, 244) | M23 (n=236, 241) | M24 (n=229, 232) | Ext M1 (n=172, 169 | Ext M2 (n=171, 169) | Ext M3 (n=169, 169) | Ext M4 (n=167, 169) | Ext M5 (n=165, 168) | Ext M6 (n=162, 167) | Ext M7 (n=161, 167) | Ext M8 (n=158, 164) | Ext M9 (n=158, 164) | Ext M10 (n=156, 164) | Ext M11 (n=153, 164) | Ext M12 (n=152, 162) | Ext M13 (n=152, 160) | Ext M14 (n=151, 159) | Ext M15 (n=149, 156) | Ext M16 (n=149, 156) | Ext M17 (n=148, 154) | Ext M18 (n=146, 154) | Ext M19 (n=143, 152) | Ext M20 (n=142, 152) | Ext M21 (n=141, 151) | Ext M22 (n=141, 149) | Ext M23 (n=139, 149) | Ext M24 (n=138, 147) | Ext M25 (n=137, 146) | Ext M26 (n=137, 145) | Ext M27 (n=137, 141) | Ext M28 (n=135, 137) | Ext M29 (n=135, 137) | Ext M30 (n=133, 137) | Ext M31 (n=124, 133) | Ext M32 (n=117, 125) | Ext M33 (n=100, 117) | Ext M34 (n=84, 90) | Ext M35 (n=66, 78) | Ext M36 (n=51, 60) | Overall comparative (n=315, 303) | Overall extension (n=172, 169) | |
| Inhaled Insulin (Exubera®) | 0.98 | 0.34 | 0.69 | 0.35 | 0.36 | 0.72 | 0.00 | 0.37 | 0.74 | 0.00 | 0.38 | 0.76 | 0.77 | 0.78 | 0.79 | 0.00 | 0.00 | 0.00 | 0.41 | 0.42 | 0.00 | 0.00 | 0.00 | 0.00 | 0.95 | 0.00 | 1.92 | 1.92 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.98 | 0.00 | 0.00 | 1.00 | 1.00 | 1.00 | 1.01 | 1.03 | 4.16 | 0.00 | 0.00 | 0.00 | 1.06 | 0.00 | 0.00 | 1.07 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.45 | 0.50 |
| Subcutaneous Insulin | 0.67 | 0.34 | 0.34 | 1.38 | 1.74 | 2.10 | 0.70 | 0.70 | 0.35 | 0.36 | 0.37 | 0.37 | 0.76 | 0.38 | 0.77 | 0.00 | 0.40 | 0.40 | 0.00 | 0.00 | 0.00 | 0.00 | 0.85 | 0.00 | 0.93 | 1.87 | 0.94 | 0.00 | 0.00 | 0.94 | 1.90 | 0.00 | 2.86 | 3.81 | 3.86 | 3.91 | 0.98 | 1.96 | 0.00 | 1.96 | 0.99 | 0.00 | 0.99 | 0.99 | 0.00 | 1.00 | 0.00 | 2.02 | 1.01 | 0.00 | 0.00 | 0.00 | 1.06 | 0.00 | 1.15 | 3.58 | 0.00 | 1.89 | 0.00 | 0.82 | 0.65 | 1.17 |
Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed. (NCT00136916)
Timeframe: Month 3 through extension follow up Month 3
| Intervention | participants (Number) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M3 (n=290, 291) | M6 (n=281, 280) | M9 (n=266, 276) | M12 (n=259, 263) | M15 (n=247, 250) | M18 (n=237, 236) | M21 (n=232, 233) | M24 (n=223, 226) | FU M1 (n=249, 221) | FU M3 (n=248, 231) | FU M6 (n=242, 220) | Ext M1 (n=161, 163) | Ext M3 (n=157, 158) | Ext M6 (n=148, 159) | Ext M9 (n=144, 157) | Ext M12 (n=144, 157) | Ext M15 (n=141, 145) | Ext M18 (n=135, 139) | Ext M21 (n=132, 143) | Ext M24 (n=125, 131) | Ext M27 (n=124, 125) | Ext M30 (n=125, 126) | Ext M33 (n=98, 113) | Ext M36 (n=54, 60) | Ext FU M3 (n=119, 115) | |
| Inhaled Insulin (Exubera®) | 2 | 3 | 7 | 7 | 13 | 10 | 12 | 14 | 11 | 16 | 13 | 12 | 12 | 14 | 11 | 19 | 15 | 17 | 22 | 22 | 18 | 20 | 10 | 5 | 14 |
| Subcutaneous Insulin | 2 | 4 | 5 | 4 | 6 | 8 | 8 | 13 | 7 | 15 | 11 | 6 | 5 | 8 | 10 | 13 | 11 | 18 | 11 | 16 | 14 | 18 | 12 | 6 | 19 |
Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed. (NCT00136916)
Timeframe: Month 3 through extension follow up Month 3
| Intervention | participants (Number) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M3 (n=289, 290) | M6 (n=278, 280) | M9 (n=266, 272) | M12 (n=258, 263) | M15 (n=246, 248) | M18(n=237, 232) | M21 (n=231, 231) | M24 (n=221, 223) | FU M1 (n=247, 220) | FU M3 (n=247, 231) | FU M6 (n=241, 219) | Ext M1 (n=159, 161) | Ext M3 (n=157, 157) | Ext M6 (n=148, 157) | Ext M9 (n=143, 155) | Ext M12 (n=141, 155) | Ext M15(n=141, 142) | Ext M18 (n=132, 138) | Ext M21(n=129, 142) | Ext M24 (n=124, 130) | Ext M27(n=123, 124) | Ext M30 (n=124, 125) | Ext M33(n=98, 113) | Ext M36 (n=52, 60) | Ext FU M3 (n=118, 114) | |
| Inhaled Insulin (Exubera®) | 0 | 1 | 0 | 4 | 1 | 2 | 0 | 4 | 2 | 3 | 5 | 3 | 3 | 4 | 4 | 8 | 4 | 6 | 4 | 5 | 7 | 7 | 1 | 2 | 6 |
| Subcutaneous Insulin | 2 | 2 | 3 | 3 | 2 | 5 | 3 | 5 | 4 | 6 | 5 | 3 | 8 | 6 | 7 | 9 | 6 | 7 | 8 | 7 | 8 | 11 | 4 | 3 | 10 |
Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine. (NCT00136916)
Timeframe: Month 3 through extension Month 36
| Intervention | units/kg (Mean) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M3 (n=301, 298) | M6 (n=289, 291) | M9 (n=275, 284) | M12 (n=266, 270) | M15 (n=258, 260) | M18 (n=243, 242) | M21 (n=240, 240) | M24 (n=229, 237) | Ext M1 (n=167, 164) | Ext M3 (n=165, 162) | Ext M6 (n=159, 164) | Ext M9 (n=156, 158) | Ext M12 (n=151, 158) | Ext M15 (n=148, 149) | Ext M18 (n=145, 145) | Ext M21 (n=137, 148) | Ext M24 (n=131, 137) | Ext M27 (n=132, 133) | Ext M30 (n=131, 130) | Ext M33 (n=104, 116) | Ext M36 (n=56, 65) | |
| Inhaled Insulin (Exubera®) | 0.51 | 0.50 | 0.50 | 0.51 | 0.52 | 0.53 | 0.53 | 0.54 | 0.53 | 0.53 | 0.54 | 0.54 | 0.54 | 0.54 | 0.54 | 0.54 | 0.55 | 0.56 | 0.56 | 0.56 | 0.53 |
| Subcutaneous Insulin | 0.54 | 0.54 | 0.55 | 0.55 | 0.56 | 0.57 | 0.57 | 0.58 | 0.59 | 0.59 | 0.60 | 0.60 | 0.60 | 0.61 | 0.61 | 0.61 | 0.61 | 0.61 | 0.62 | 0.61 | 0.61 |
Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine. (NCT00136916)
Timeframe: Month 3 through extension Month 36
| Intervention | units (Mean) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M3 (n=301, 298) | M6 (n=289, 291) | M9 (n=275, 284) | M12 (n=266, 270) | M15 (n=258, 260) | M18 (n=243, 242) | M21 (n=240, 240) | M24 (n=229, 237) | Ext M1 (n=167, 164) | Ext M3 (n=165, 162) | Ext M6 (n=159, 164) | Ext M9 (n=156, 158) | Ext M12 (n=151, 158) | Ext M15 (n=148, 149) | Ext M18 (n=145, 145) | Ext M21 (n=137, 148) | Ext M24 (n=131, 137) | Ext M27 (n=132, 133) | Ext M30 (n=131, 130) | Ext M33 (n=104, 116) | Ext M36 (n=56, 65) | |
| Inhaled Insulin (Exubera®) | 44.10 | 44.03 | 43.64 | 44.62 | 45.02 | 46.07 | 46.67 | 46.62 | 45.29 | 45.76 | 45.89 | 46.51 | 46.52 | 46.39 | 46.31 | 46.49 | 47.21 | 48.13 | 48.13 | 48.38 | 46.42 |
| Subcutaneous Insulin | 47.98 | 47.31 | 48.11 | 48.01 | 48.37 | 48.93 | 49.84 | 50.34 | 51.29 | 51.62 | 52.18 | 52.32 | 51.72 | 52.92 | 52.37 | 52.68 | 52.18 | 52.42 | 53.22 | 51.93 | 53.47 |
Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg). (NCT00136916)
Timeframe: Month 3 through extension Month 36
| Intervention | mg/kg, units/kg (Mean) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M3 (n=302, 299) | M6 (n=290, 292) | M9 (n=275, 285) | M12 (n=266, 270) | M15 (n=258, 261) | M18 (n=245, 242) | M21 (n=240, 242) | M24 (n=229, 238) | Ext M1 (n=167, 164) | Ext M3 (n=165, 163) | Ext M6 (n=159, 165) | Ext M9 (n=156, 161) | Ext M12 (n=151, 160) | Ext M15 (n=148, 151) | Ext M18 (n=145, 146) | Ext M21 (n=138, 149) | Ext M24 (n=131, 138) | Ext M27 (n=132, 134) | Ext M30 (n=131, 131) | Ext M33 (n=105, 117) | Ext M36 (n=56, 66) | |
| Inhaled Insulin (Exubera®) (mg) | 0.15 | 0.15 | 0.16 | 0.17 | 0.17 | 0.17 | 0.17 | 0.18 | 0.16 | 0.17 | 0.17 | 0.17 | 0.18 | 0.18 | 0.18 | 0.18 | 0.18 | 0.19 | 0.19 | 0.19 | 0.19 |
| Subcutaneous Insulin (Units) | 0.36 | 0.36 | 0.36 | 0.37 | 0.37 | 0.38 | 0.39 | 0.40 | 0.40 | 0.41 | 0.41 | 0.42 | 0.43 | 0.42 | 0.44 | 0.43 | 0.45 | 0.45 | 0.46 | 0.47 | 0.48 |
Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin. (NCT00136916)
Timeframe: Month 3 through extension Month 36
| Intervention | mg, units (Mean) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| M3 (n=302, 299) | M6 (n=290, 292) | M9 (n=275, 285) | M12 (n=266, 270) | M15 (n=258, 261) | M18 (n=245, 242) | M21 (n=240, 242) | M24 (n=229, 238) | Ext M1 (n=167, 164) | Ext M3 (n=165, 163) | Ext M6 (n=159, 165) | Ext M9 (n=156, 161) | Ext M12 (n=151, 160) | Ext M15 (n=148, 151) | Ext M18 (n=145, 146) | Ext M21 (n=138, 149) | Ext M24 (n=131, 138) | Ext M27 (n=132, 134) | Ext M30 (n=131, 131) | Ext M33 (n=105, 117) | Ext M36 (n=56, 66) | |
| Inhaled Insulin (Exubera®) (mg) | 12.66 | 13.18 | 13.57 | 14.40 | 14.70 | 14.91 | 15.09 | 15.43 | 13.89 | 14.62 | 14.62 | 14.82 | 15.42 | 15.48 | 15.57 | 15.94 | 15.46 | 16.25 | 16.56 | 16.51 | 17.25 |
| Subcutaneous Insulin (Units) | 31.15 | 31.73 | 31.58 | 31.94 | 31.88 | 32.79 | 33.18 | 34.04 | 34.52 | 35.29 | 35.43 | 35.68 | 36.56 | 36.27 | 37.37 | 36.80 | 38.51 | 38.54 | 39.01 | 40.33 | 42.34 |
2 reviews available for carbon monoxide and Diabetes Mellitus, Adult-Onset
| Article | Year |
|---|---|
A critical and comprehensive insight on heme oxygenase and related products including carbon monoxide, bilirubin, biliverdin and ferritin in type-1 and type-2 diabetes.
Topics: Animals; Bilirubin; Biliverdine; Carbon Monoxide; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type | 2014 |
The heme oxygenase system and type-1 diabetes.
Topics: Animals; Bilirubin; Carbon Monoxide; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Heme Oxyg | 2014 |
2 trials available for carbon monoxide and Diabetes Mellitus, Adult-Onset
| Article | Year |
|---|---|
Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes.
Topics: Administration, Inhalation; Blood Glucose; Carbon Monoxide; Diabetes Mellitus, Type 2; Diffusion; Fe | 2008 |
Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: A 12-month, randomized, noninferiority trial.
Topics: Administration, Inhalation; Adult; Age of Onset; Aged; Asthma; Body Mass Index; Carbon Monoxide; Dia | 2009 |
16 other studies available for carbon monoxide and Diabetes Mellitus, Adult-Onset
| Article | Year |
|---|---|
Dynamic diffusion lung capacity of carbon monoxide (DLCO) as a predictor of pulmonary microangiopathy and its association with extra pulmonary microangiopathy in patients with type II diabetes mellitus.
Topics: Adolescent; Carbon Monoxide; Diabetes Mellitus, Type 2; Humans; Lung; Lung Volume Measurements; Resp | 2022 |
Carbon monoxide and β-cell function: Implications for type 2 diabetes mellitus.
Topics: Carbon Monoxide; Diabetes Mellitus, Type 2; Gasotransmitters; Humans; Hydrogen Sulfide; Nitric Oxide | 2022 |
Expression levels of enzymes generating NO and CO in islets of murine and human diabetes.
Topics: Animals; Carbon Monoxide; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Female; Heme O | 2019 |
Relationship between glycated haemoglobin concentration and erythrocyte survival in type 2 diabetes mellitus determined by a modified carbon monoxide breath test.
Topics: Adult; Blood Glucose; Breath Tests; Carbon Monoxide; Case-Control Studies; Cell Survival; Diabetes M | 2018 |
Acute effects of air pollution on type II diabetes mellitus hospitalization in Shijiazhuang, China.
Topics: Adult; Aged; Air Pollutants; Air Pollution; Carbon Monoxide; China; Cities; Diabetes Mellitus, Type | 2018 |
Heme bound amylin: spectroscopic characterization, reactivity, and relevance to type 2 diabetes.
Topics: Amino Acid Sequence; Carbon Monoxide; Catalase; Diabetes Mellitus, Type 2; Heme; Humans; Islet Amylo | 2013 |
Induction of heme oxygenase-1 ameliorates vascular dysfunction in streptozotocin-induced type 2 diabetic rats.
Topics: Acetylcysteine; Animals; Carbon Monoxide; Cyclooxygenase 2; Diabetes Mellitus, Experimental; Diabete | 2014 |
Abnormally decreased NO and augmented CO production in islets of the leptin-deficient ob/ob mouse might contribute to explain hyperinsulinemia and islet survival in leptin-resistant type 2 obese diabetes.
Topics: Animals; Blood Glucose; Carbon Monoxide; Diabetes Mellitus, Type 2; Enzyme Assays; Female; Glucagon; | 2011 |
[Correlation of homocysteine in plasma with NOS and endogenous CO in the penile corpus cavernosum of type 2 diabetic rats].
Topics: Animals; Carbon Monoxide; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 2; Folic Acid; Ho | 2012 |
[Ventilatory mechanics and alveolo-capillary diffusion in diabetes].
Topics: Adolescent; Adult; Carbon Monoxide; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Hu | 2002 |
Relationship between GHb concentration and erythrocyte survival determined from breath carbon monoxide concentration.
Topics: Adult; Aged; Breath Tests; Carbon Monoxide; Diabetes Mellitus, Type 2; Erythrocyte Aging; Glycated H | 2004 |
Pulmonary functions in patients with type 2 diabetes mellitus & correlation with anthropometry & microvascular complications.
Topics: Adult; Analysis of Variance; Anthropometry; Carbon Monoxide; Diabetes Mellitus, Type 2; Diabetic Ang | 2004 |
Spotlight on inhaled human insulin (exubera((r))) in diabetes mellitus.
Topics: Administration, Inhalation; Carbon Monoxide; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; H | 2006 |
Diminished alveolar microvascular reserves in type 2 diabetes reflect systemic microangiopathy.
Topics: Acetylene; Adult; Antihypertensive Agents; Body Mass Index; Breath Tests; Carbon Monoxide; Cross-Sec | 2008 |
Exhaled carbon monoxide levels elevated in diabetes and correlated with glucose concentration in blood: a new test for monitoring the disease?
Topics: Adult; Aged; Blood Glucose; Breath Tests; Carbon Monoxide; Diabetes Mellitus, Type 1; Diabetes Melli | 1999 |
Comparison of questionnaire, breath carbon monoxide and urine cotinine in assessing the smoking habits of Type 2 diabetic patients.
Topics: Adult; Aged; Aged, 80 and over; Breath Tests; Carbon Monoxide; Cotinine; Diabetes Mellitus, Type 2; | 2000 |