Abstract | AIMS: METHODS: This was a double-blind, randomized, multicentre, active-controlled, parallel-group study of 24-week treatment with vildagliptin (100 mg daily, n=169) or metformin (titrated to 1500 mg daily, n=166) in drug-naïve patients with type 2 diabetes aged>or=65 years (baseline HbA1c 7-9%). RESULTS: Participants had a mean age of 71 years, known duration of diabetes of 3 years and mean baseline HbA1c of 7.7%. At end-point, vildagliptin was as effective as metformin, improving HbA1c by -0.64+/-0.07% and -0.75+/-0.07%, respectively, meeting the predefined statistical criterion for non-inferiority (upper limit of 95% confidence interval for between-treatment difference<or=0.3%). Body weight changes were -0.45+/-0.20 kg in vildagliptin-treated patients (p=0.02) and -1.25+/-0.19 kg in metformin-treated patients (p<0.001; p=0.004 vs. vildagliptin). The proportion of patients experiencing an adverse event (AE) was 44.3 vs. 50.3% in patients receiving vildagliptin and metformin respectively. Gastrointestinal (GI) AEs were significantly more frequent with metformin (24.8%) than with vildagliptin (15.0%, p=0.028), mainly driven by a 4.4-fold higher incidence of diarrhoea. A low incidence of hypoglycaemia was observed in both treatment groups (0% with vildagliptin and 1.2% with metformin). CONCLUSIONS:
Vildagliptin is an effective and well-tolerated treatment option in elderly patients with type 2 diabetes, demonstrating similar improvement in glycaemic control as metformin, with superior GI tolerability.
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Authors | A Schweizer, S Dejager, E Bosi |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 11
Issue 8
Pg. 804-12
(Aug 2009)
ISSN: 1463-1326 [Electronic] England |
PMID | 19476473
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Dipeptidyl-Peptidase IV Inhibitors
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Nitriles
- Pyrrolidines
- Metformin
- Vildagliptin
- Adamantane
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Topics |
- Adamantane
(adverse effects, analogs & derivatives, therapeutic use)
- Aged
- Aged, 80 and over
- Blood Glucose
- Body Weight
(drug effects)
- Diabetes Mellitus, Type 2
(drug therapy)
- Dipeptidyl-Peptidase IV Inhibitors
(adverse effects, therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Gastrointestinal Diseases
(epidemiology)
- Glycated Hemoglobin
(drug effects)
- Humans
- Hypoglycemia
(epidemiology)
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Incidence
- Male
- Metformin
(adverse effects, therapeutic use)
- Nitriles
(adverse effects, therapeutic use)
- Pyrrolidines
(adverse effects, therapeutic use)
- Vildagliptin
|