Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: In this randomized, parallel-group, placebo-controlled, multicentre study, 806 patients with type 2 diabetes (mean duration, 3 years) who had failed diet and exercise were randomly assigned to 4 weeks of therapy with placebo, glyburide 2.5 mg, metformin 500 mg, glyburide/metformin 1.25/250 mg, or glyburide/metformin 2.5/500 mg once daily. Doses were then titrated over 8 weeks based on glycaemic response. The primary outcome measure was change from baseline in mean HbA1c after 20 weeks. Changes in fasting plasma glucose, lipids and body weight were also assessed along with 2-h postprandial glucose and insulin values after a standardized meal. RESULTS: At week 20, patients taking glyburide/metformin 1.25/250 mg or 2.5/500 mg tablets had greater reductions in HbA1c levels (-1.48% and -1.53% respectively) compared with placebo (-0.21%; both p < 0.001), glyburide (-1.24%; p = 0.016 and p = 0.004 respectively) or metformin (-1.03%; both p < 0.001). Fasting plasma glucose concentrations were reduced more in both glyburide/metformin groups compared with placebo and metformin (p < 0.001); patients in both combination therapy groups also had significantly lower postprandial glucose concentrations compared with placebo, glyburide and metformin. CONCLUSIONS:
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Authors | A J Garber, J Larsen, S H Schneider, B A Piper, D Henry, Glyburide/Metformin Initial Therapy Study Group |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 4
Issue 3
Pg. 201-8
(May 2002)
ISSN: 1462-8902 [Print] England |
PMID | 12047399
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Hypoglycemic Agents
- Placebos
- Metformin
- Glyburide
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Topics |
- Blood Glucose
(drug effects, metabolism)
- Body Weight
(drug effects)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Drug Therapy, Combination
- Fasting
- Female
- Glyburide
(adverse effects, therapeutic use)
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Male
- Metformin
(adverse effects, therapeutic use)
- Middle Aged
- Placebos
- Postprandial Period
- Racial Groups
- Safety
- United States
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