Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients

Bayer287 enrolled

Overview

To demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as compared to metformin monotherapy in the treatment of subjects with T2DM that is inadequately controlled by metformin alone

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

287

Conditions

Diabetes Mellitus, Type 2

Interventions

AcarboseDRUG

Uptitrated in the treatment phase from 50 mg per day for 1 week, followed by 100 mg per day for another week, and 150 mg per day for the rest 14 weeks, oral, with the first mouthful of main meal

MetforminDRUG

500 mg 3 times daily, oral, with the first mouthful of main meal

PlaceboDRUG

Acarbose matching placebo, oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females, aged 18 to less than 80 years * Diabetes mellitus type 2, that is insufficently controlled with metformin defined by HbA1c between 7.0 % and 10.0%, inclusive * Body mass index between 22 and 45 kg/m\^2, inclusive * Women and men of reproductive potential must agree to use adequate contraception when sexually active Exclusion Criteria: * Fasting plasma glucose \> 14.0 mmol/L * Severe metabolic diabetic complications