Abstract | OBJECTIVES: METHODS: Patients who were on a stable dose of metformin (> or = 1500 mg/day) for at least 8 weeks were randomised in a double-blind manner to receive either sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (up-titrated up to 20 mg/day based upon prespecified glycaemic criteria) (N = 584). The efficacy analysis assessed the change in HbA(1c) from baseline using the per-protocol (PP) population. RESULTS: For the PP cohort, mean baseline HbA(1c) was 7.3% in both groups. After 2 years, the least squares (LS) mean change in HbA(1c) from baseline [95% confidence interval (CI)] was -0.54% (-0.64, -0.45) with sitagliptin (n = 248) and -0.51% (-0.60, -0.42) with glipizide (n = 256). The rise in HbA(1c) from week 24 to week 104 [i.e. coefficient of durability (COD)] was smaller with sitagliptin [COD (95% CI) 0.16%/year (0.10, 0.21)] compared with glipizide [0.26%/year (0.21, 0.31)]. The proportion of patients with an HbA(1c)< 7% was 63% and 59% with sitagliptin and glipizide, respectively. The beta-cell responsiveness to a meal challenge was maintained with sitagliptin and decreased with glipizide. The proportion of patients who reported hypoglycaemia was 5% with sitagliptin and 34% with glipizide [difference in proportions (95% CI) = -29% (-33, -25)]. Relative to baseline, sitagliptin was associated with weight loss (-1.6 kg) compared with weight gain (+0.7 kg) with glipizide. CONCLUSION:
|
Authors | T Seck, M Nauck, D Sheng, S Sunga, M J Davies, P P Stein, K D Kaufman, J M Amatruda, Sitagliptin Study 024 Group |
Journal | International journal of clinical practice
(Int J Clin Pract)
Vol. 64
Issue 5
Pg. 562-76
(Apr 2010)
ISSN: 1742-1241 [Electronic] India |
PMID | 20456211
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Pyrazines
- Triazoles
- Metformin
- Sitagliptin Phosphate
- Glipizide
|
Topics |
- Adult
- Aged
- Blood Glucose
(metabolism)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Double-Blind Method
- Fasting
(blood)
- Female
- Glipizide
(therapeutic use)
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemic Agents
(therapeutic use)
- Insulin-Secreting Cells
(drug effects)
- Male
- Metformin
(therapeutic use)
- Middle Aged
- Pyrazines
(therapeutic use)
- Sitagliptin Phosphate
- Treatment Outcome
- Triazoles
(therapeutic use)
- Young Adult
|