Dose-Dependent Effects of Glyburide on Insulin Secretion and Glucose Uptake in Humans

Groop, Leif; Barzilai, Nir; Ratheiser, Klaus; Luzi, Livio; Wåhlin-Boll, E; Melander, Arne; DeFronzo, Ralph A.

doi:10.2337/diacare.14.8.724

Cited by 71 publications

(50 citation statements)

References 9 publications

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“…Main inclusion criteria for all three initial placebo-controlled trials were age between 16 and 75 years and DM2 treated for at least 3 months prior to screening with the maximally effective dose of an SU [27][28][29], or !1500 mg/day of MET, or a combination of these doses of SU and MET. Additional criteria were an A1C between 7.1 and 11.0%, fasting plasma glucose (FPG) concentration <13.3 mmol/L and body mass index (BMI) of 27-45 kg/m 2 .…”

Section: Study Patientsmentioning

confidence: 99%

Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes

Blonde

Klein

Han³

et al. 2006

Diabetes Obesity Metabolism

384

324

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Aim: Exenatide, an incretin mimetic for the adjunct treatment of type 2 diabetes (DM2), reduced A1C and weight in 30-week placebo-controlled trials. This analysis examined the effects of exenatide on glycaemic control and weight over an 82-week period in patients with DM2 unable to achieve adequate glycaemic control with sulphonylurea (SU) and/or metformin (MET). [À0.9 AE 0.1% (mean AE SE)] was sustained to week 82 (À1.1 AE 0.1%), with 48% of patients achieving A1C 7% at week 82. At week 30, exenatide reduced body weight (a secondary endpoint) from baseline (À2.1 AE 0.2 kg), with progressive reduction at week 82 (À4.4 AE 0.3 kg). Similar results were observed for the intent-to-treat population (n ¼ 551), with reductions in A1C and weight at week 82 of À0.8 AE 0.1% and À3.5 AE 0.2 kg respectively. The 82-week completer cohort showed statistically significant improvement in some cardiovascular risk factors. The most frequent adverse events were generally mild-to-moderate nausea and hypoglycaemia. Conclusion: In summary, 82 weeks of adjunctive exenatide treatment in patients with DM2 treated with SU and/or MET resulted in sustained reduction in A1C and progressive reduction in weight, as well as improvement in some cardiovascular risk factors.

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Section: Study Patientsmentioning

confidence: 99%

Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes

Blonde

Klein

Han³

et al. 2006

Diabetes Obesity Metabolism

384

324

View full text Add to dashboard Cite

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“…This drug decreases the insulin resistance and improves insulin secretion, the pathogenic factors in the causation of hyperglycemia in GDM (Groop et al, 1991;Rossetti et al, 1990). Another advantage is that, the human placental transfer of glibenclamide is negligible.…”

Section: Oral Hypoglycemic Agents 731 Glibenclamidementioning

confidence: 99%

Gestational Diabetes Mellitus - A Perspective

Seshiah¹,

Balaji²,

Balaji³

2011

Gestational Diabetes

200

287

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“…In an effort to standardize sulfonylurea use at study initiation, if required, subjects had their sulfonylurea dose adjusted before the placebo lead-in period to the maximally effective dose (4 mg/day glimepiride, 20 mg/day glipizide, 10 mg/ day glipizide XL, 10 mg/day glyburide, 6 mg/day micronized glyburide, 350 mg/ day chlorpropamide, or 500 mg/day tolazamide) (15)(16)(17). To address the risk of hypoglycemia, the protocol recommended progressive 50% reductions in sulfonylurea dose, eventual discontinuation (depending on the recurrence of hypoglycemia) in the event of a documented episode of hypoglycemia (glucose Ͻ60 mg/dl), or two undocumented but suspected episodes of hypoglycemia.…”

mentioning

confidence: 99%

Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Sulfonylurea-Treated Patients With Type 2 Diabetes

Buse

Henry

Han³

et al. 2004

Diabetes Care

1,164

1,078

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OBJECTIVE -This study evaluated the ability of the incretin mimetic exenatide (exendin-4) to improve glycemic control in patients with type 2 diabetes failing maximally effective doses of a sulfonylurea as monotherapy. RESEARCH DESIGN AND METHODS-This was a triple-blind, placebo-controlled, 30-week study conducted at 101 sites in the U.S. After a 4-week, single-blind, placebo lead-in period, 377 subjects were randomized (60% men, age 55 Ϯ 11 years, BMI 33 Ϯ 6 kg/m 2 , HbA 1c 8.6 Ϯ 1.2% [ϮSD]) and began 4 weeks at 5 g subcutaneous exenatide twice daily (before breakfast and dinner; arms A and B) or placebo. Subsequently, subjects in arm B were escalated to 10 g b.i.d. exenatide. All subjects continued sulfonylurea therapy.RESULTS -At week 30, HbA 1c changes from baseline were Ϫ0.86 Ϯ 0.11, Ϫ0.46 Ϯ 0.12, and 0.12 Ϯ 0.09% (ϮSE) in the 10-g, 5-g, and placebo arms, respectively (adjusted P Ͻ 0.001). Of evaluable subjects with baseline HbA 1c Ͼ 7% (n ϭ 237), 41% (10 g), 33% (5 g), and 9% (placebo) achieved HbA 1c Յ 7% (P Ͻ 0.001). Fasting plasma glucose concentrations decreased in the 10-g arm compared with placebo (P Ͻ 0.05). Subjects in the exenatide arms had dose-dependent progressive weight loss, with an end-of-study loss in the 10-g exenatide arm of Ϫ1.6 Ϯ 0.3 kg from baseline (P Ͻ 0.05 vs. placebo). The most frequent adverse events were generally mild or moderate and gastrointestinal in nature. No severe hypoglycemia was observed.CONCLUSIONS -Exenatide significantly reduced HbA 1c in patients with type 2 diabetes failing maximally effective doses of a sulfonylurea. Exenatide was generally well tolerated and was associated with weight loss.

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Dose-Dependent Effects of Glyburide on Insulin Secretion and Glucose Uptake in Humans

Cited by 71 publications

References 9 publications

Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes

Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes

Gestational Diabetes Mellitus - A Perspective

Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Sulfonylurea-Treated Patients With Type 2 Diabetes

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