Efficacy and tolerability of vildagliptin in drug-naïve patients with type 2 diabetes and mild hyperglycaemia*.
OBJECTIVE
This study was conducted to assess efficacy and tolerability of vildagliptin in drug-naïve patients with type 2 diabetes and mild hyperglycaemia.


METHODS
Multicentre, double-blind, randomized, placebo-controlled, parallel-group study of 52-week treatment with vildagliptin (50 mg q.d.) in 306 drug-naïve patients with type 2 diabetes (A1C = 6.2-7.5%). A1C, fasting plasma glucose (FPG) and measures of prandial glucose control and beta-cell function determined during standard meal tests were assessed.


RESULTS
Baseline A1C and FPG averaged 6.7% and 7.1 mmol/l, respectively, in patients randomized to vildagliptin (n = 156) and 6.8% and 7.2 mmol/l in those randomized to placebo (n = 150). A1C decreased modestly in vildagliptin-treated patients (Delta = -0.2 +/- 0.1%) and increased in patients receiving placebo (Delta = 0.1 +/- 0.1%). The between-group difference (vildagliptin - placebo) in adjusted mean change (AM Delta) in A1C was -0.3 +/- 0.1% (p < 0.001). FPG increased in patients receiving placebo (Delta = 0.5 +/- 0.1 mmol/l) and to a significantly lesser extent in vildagliptin-treated patients (between-group difference in AM Delta FPG = -0.4 +/- 0.2 mmol/l, p = 0.032). Relative to placebo, 2-h postprandial glucose (PPG) decreased (-0.9 +/- 0.4 mmol/l, p = 0.012), and insulin secretory rate (ISR) relative to glucose [ISR area under the curve (AUC)(0-2) (h)/glucose AUC(0-2) (h)] increased (+5.0 +/- 1.2 pmol/min/m(2)/mM, p < 0.001). Mean body weight decreased by 0.5 +/- 0.3 kg in vildagliptin-treated patients and by 0.2 +/- 0.3 kg in patients receiving placebo. The side-effect profile of vildagliptin was similar to that of placebo, and one hypoglycaemic episode occurred in one patient receiving placebo.


CONCLUSIONS
In drug-naïve patients with mild hyperglycaemia, relative to placebo, 52-week treatment with vildagliptin 50 mg q.d. significantly decreases A1C, FPG and PPG and improves beta-cell function without weight gain or hypoglycaemia.
Scherbaum
W A
WA
Department of Endocrinology, Diabetes and Rheumatology, University Hospital Duesseldorf, Duesseldorf, Germany.
Schweizer
A
A
Mari
A
A
Nilsson
P M
PM
Lalanne
G
G
Jauffret
S
S
Foley
J E
JE
D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy* / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D019518:Postprandial Period / Q000187:drug effects; D011759:Pyrrolidines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D000077597:Vildagliptin
D000218:Adamantane; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin