Acarbose improves glycemic control in overweight type 2 diabetic patients insufficiently treated with metformin.
OBJECTIVE
To investigate the efficacy and safety of acarbose as add-on therapy in overweight type 2 patients with diabetes inadequately controlled by metformin.


METHODS
This study adopted a multicenter, randomized, double-blind, placebo-controlled, parallel group design. After a 4-week placebo run-in period, subjects were randomized to either acarbose (titrated up to 100 mg b.i.d.) or placebo. The primary efficacy variable was the change in HbA(1c) from baseline to the end of the 24-week treatment period. Change in fasting blood glucose was assessed as a secondary efficacy parameter.


RESULTS
The intention-to-treat analysis from baseline to week 24 (81 patients for HbA(1c) and 82 for fasting blood glucose) showed statistically significant differences between acarbose and placebo treatment in HbA(1c) (1.02%; 95% CI 0.543-1.497; P = 0.0001) and fasting blood glucose (1.132 mmol/l; 95% CI 0.056-2.208; P = 0.0395) (adjusted least square means). In all, 18 patients (47%) in the acarbose group were classified as responders with a > or =5% reduction in HbA(1c) (relative to baseline) at the end point compared to 6 (14%) in the placebo group (P = 0.001). The safety profiles were similar for both treatment groups except for the higher incidence of gastrointestinal side effects during acarbose therapy.


CONCLUSIONS
The addition of acarbose to metformin monotherapy provides an efficacious and safe alternative for glycemic improvement in overweight type 2 patients inadequately controlled by metformin alone.
Phillips
Patrick
P
Department of Endocrinology, The Queen Elizabeth Hospital, Woodville, Australia. patrick.phillips@nwahs.sa.gov.au
Karrasch
Jeff
J
Scott
Russell
R
Wilson
Dennis
D
Moses
Robert
R
D020909:Acarbose / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D009765:Obesity; D010919:Placebos / Q000627:therapeutic use; D019233:Retreatment; D016896:Treatment Outcome
D020909:Acarbose; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010919:Placebos