Double-blind evaluation of efficacy and tolerability of metformin in NIDDM.
OBJECTIVE
To test the efficacy and tolerability of metformin.


METHODS
An 8-mo double-blind placebo-controlled parallel-group trial was performed at University hospital diabetic clinics on 60 patients with non-insulin-dependent diabetes mellitus (NIDDM) treated by diet alone. Metformin was administered and built up to a maximum dosage of 1 g three times daily.


RESULTS
Mean HbA1 fell from 11.7 +/- 0.4 to 10.3 +/- 0.4% (means +/- SE) on metformin but rose from 11.8 +/- 0.4 to 13.3 +/- 0.4% on placebo (P less than 0.001). Final mean fasting blood glucose was 5.1 mM lower with metformin than placebo (P less than 0.001). No other biochemical variable differed significantly, and weight did not change. A favorable glycemic response was not restricted to the obese. The mean final dosage of metformin was 1.7 +/- 0.1 g and was well tolerated.


CONCLUSIONS
Metformin achieved a 23% lower mean HbA1 than placebo without weight gain or significant unwanted effects.
Dornan
T L
TL
Nottingham University and City Hospitals, United Kingdom.
Heller
S R
SR
Peck
G M
GM
Tattersall
R B
RB
D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D008875:Middle Aged
D006442:Glycated Hemoglobin; D008687:Metformin