Abstract | OBJECTIVE: METHODS: This was a randomized, parallel-group, multinational, non-inferiority clinical trial with an active-controlled, double-blind treatment period in which patients ≥ 65 and ≤ 85 years of age with T2DM were screened at 85 sites. Patients were randomized to once-daily sitagliptin (100 or 50 mg, depending on renal function) or glimepiride (in titrated doses) for 30 weeks. The main outcome measures were change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and body weight; and the incidence of symptomatic hypoglycemia. RESULTS: The mean baseline HbA1c was 7.8% in both the sitagliptin group (n = 197) and the glimepiride group (n = 191). After 30 weeks, the least squares (LS) mean change in HbA1c baseline was -0.32% with sitagliptin and -0.51 % with glimepiride, for a between-group difference (95% CI) of 0.19% (0.03-0.34). This result met the pre-specified criterion for declaring non-inferiority, which required that the upper 95% confidence limit lie below 0.4%. The LS mean change in FPG from baseline was -14.5 mg/dL with sitagliptin and -21.2 mg/dL with glimepiride, for a between-group difference (95% CI) of 6.7 mg/dL (0.7-12.7). The percentages of patients with adverse events of symptomatic hypoglycemia were 0.8% in the sitagliptin group and 4.7% in the glimepiride group (between-treatment difference = -3.9%, p = 0.009). The LS mean change in body weight from baseline was 0.4 kg with sitagliptin and 1.1 kg with glimepiride, for a between-group difference of -0.7 kg (p = 0.011). CONCLUSION: STUDY IDENTIFIER: ClinicalTrials.gov NCT01189890.
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Authors | Paul Hartley, Yue Shentu, Patricia Betz-Schiff, Gregory T Golm, Christine McCrary Sisk, Samuel S Engel, R Ravi Shankar |
Journal | Drugs & aging
(Drugs Aging)
Vol. 32
Issue 6
Pg. 469-76
(Jun 2015)
ISSN: 1179-1969 [Electronic] New Zealand |
PMID | 26041585
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Sulfonylurea Compounds
- glimepiride
- Sitagliptin Phosphate
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Topics |
- Age Factors
- Aged
- Aged, 80 and over
- Blood Glucose
(metabolism)
- Body Weight
(drug effects)
- Diabetes Mellitus, Type 2
(blood, drug therapy, metabolism)
- Diet
- Double-Blind Method
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemia
(chemically induced)
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Male
- Sitagliptin Phosphate
(adverse effects, therapeutic use)
- Sulfonylurea Compounds
(adverse effects, therapeutic use)
- Treatment Outcome
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