Comparison of vildagliptin and metformin monotherapy in elderly patients with type 2 diabetes: a 24-week, double-blind, randomized trial.
OBJECTIVE
The study evaluated the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor, vildagliptin, and metformin in drug-naïve elderly patients with type 2 diabetes. The primary objective was to demonstrate non-inferiority of vildagliptin vs. metformin in glycated haemoglobin (HbA1c) reduction.


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.
Schweizer
A
A
Novartis Pharma AG, Basel, Switzerland. anja.schweizer@novartis.com
Dejager
S
S
Bosi
E
E
D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000453:epidemiology; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D000077597:Vildagliptin
D000218:Adamantane; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin