Efficacy and tolerability of vildagliptin vs. pioglitazone when added to metformin: a 24-week, randomized, double-blind study.
Diabetes Obes Metab
; 10(1): 82-90, 2008 Jan.
Article
in En
| MEDLINE
| ID: mdl-18034842
ABSTRACT
AIM:
The aim of this study was to compare the efficacy and tolerability of vildagliptin vs. pioglitazone as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy.METHODS:
This 24-week, multicentre, double-blind, randomized, active-controlled study compared vildagliptin (100 mg daily, given as equally divided doses, n = 295) and pioglitazone (30 mg daily, given as a single q.d. dose, n = 281) in patients with inadequate glycaemic control (A1C 7.5-11%) while receiving a stable metformin dose (> or =1500 mg daily). The adjusted mean changes from baseline to study endpoint (AMDelta) in A1C, fasting plasma glucose (FPG), fasting lipids and body weight were compared by analysis of covariance.RESULTS:
When added to a stable dose of metformin (mean dose at baseline >2000 mg/day), both vildagliptin and pioglitazone decreased A1C (AMDelta = -0.9 +/- 0.1% and -1.0 +/- 0.1%, respectively) from identical baseline values (8.4 +/- 0.1%). The between-group difference in AMDelta A1C was 0.1 +/- 0.1%, and non-inferiority of vildagliptin to pioglitazone was established at both 0.4 and 0.3% margins for upper limit of the 95% confidence intervals. Pioglitazone decreased FPG (AMDelta = -2.1 +/- 0.1 mmol/l) to a greater extent than vildagliptin (AMDelta = -1.4 +/- 0.1 mmol/l), but only pioglitazone increased body weight (AMDelta = +1.9 +/- 0.2 kg between-group difference = -1.6 +/- 0.3 kg, p < 0.001). Adverse events (AEs) were reported by 60% of vildagliptin-treated patients and by 56.4% of pioglitazone-treated patients; serious AEs were reported by 2.0 and 4.6% of patients receiving vildagliptin and pioglitazone respectively. Mild hypoglycaemia was reported by one patient (0.3%) in the vildagliptin group and by no patients receiving pioglitazone.CONCLUSIONS:
When added to metformin, the efficacy of vildagliptin is non-inferior to that of pioglitazone. The treatments were similarly well tolerated, but only pioglitazone increased body weight.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pyrrolidines
/
Adamantane
/
Thiazolidinediones
/
Diabetes Mellitus, Type 2
/
Hypoglycemic Agents
/
Metformin
/
Nitriles
Type of study:
Clinical_trials
Limits:
Adolescent
/
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Diabetes Obes Metab
Journal subject:
ENDOCRINOLOGIA
/
METABOLISMO
Year:
2008
Document type:
Article
Affiliation country:
Italy