| Abstract | AIM: To compare the efficacy and safety of sitagliptin vs. glipizide in patients with type 2 diabetes and inadequate glycaemic control [haemoglobin A(1c) (HbA(1c)) > or = 6.5 and < or = 10%] on metformin monotherapy. METHODS: After a metformin dose titration/stabilization period (> or = 1500 mg/day), 1172 patients were randomized to the addition of sitagliptin 100 mg q.d. (N = 588) or glipizide 5 mg/day (uptitrated to a potential maximum 20 mg/day) (N = 584) for 52 weeks. The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA(1c) changes from baseline at Week 52 using a per-protocol approach. RESULTS: From a mean baseline of 7.5%, HbA(1c) changes from baseline were -0.67% at Week 52 in both groups, confirming non-inferiority. The proportions achieving an HbA(1c) < 7% were 63% (sitagliptin) and 59% (glipizide). Fasting plasma glucose changes from baseline were -0.56 mmol/l (-10.0 mg/dl) and -0.42 mmol/l (-7.5 mg/dl) for sitagliptin and glipizide, respectively. The proportion of patients experiencing hypoglycaemia episodes was significantly (p < 0.001) higher with glipizide (32%) than with sitagliptin (5%), with 657 events in glipizide-treated patients compared with 50 events in sitagliptin-treated patients. Sitagliptin led to weight loss (change from baseline =-1.5 kg) compared with weight gain (+1.1 kg) with glipizide [between-treatment difference (95% confidence interval) =-2.5 kg (-3.1, -2.0); p < 0.001]. CONCLUSIONS: In this study, the addition of sitagliptin compared with glipizide provided similar HbA(1c)-lowering efficacy over 52 weeks in patients on ongoing metformin therapy. Sitagliptin was generally well tolerated, with a lower risk of hypoglycaemia relative to glipizide and with weight loss compared with weight gain with glipizide. |
| Authors | M A Nauck, G Meininger, D Sheng, L Terranella, P P Stein, Sitagliptin Study 024 Group
(Affiliation: Diabeteszentrum Bad Lauterberg im Harz, Bad Lauterberg, Germany.)
|
| Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 9
Issue 2
Pg. 194-205
(Mar 2007)
ISSN: 1462-8902 England |
| PMID | 17300595
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Blood Glucose
- Hemoglobin A, Glycosylated
- Hypoglycemic Agents
- Protease Inhibitors
- Pyrazines
- Triazoles
- hemoglobin A1c protein, human
- sitagliptin
- Insulin
- Glipizide
- Metformin
- Antigens, CD26
- DPP4 protein, human
|
| Topics |
- Adolescent
- Adult
- Aged
- Antigens, CD26
(antagonists & inhibitors)
- Blood Glucose
(metabolism)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Double-Blind Method
- Female
- Glipizide
(adverse effects, therapeutic use)
- Hemoglobin A, Glycosylated
(metabolism)
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Insulin
(blood)
- Male
- Metformin
(therapeutic use)
- Middle Aged
- Protease Inhibitors
(adverse effects, therapeutic use)
- Pyrazines
(adverse effects, therapeutic use)
- Treatment Outcome
- Triazoles
(adverse effects, therapeutic use)
|
