Diabetes Mellitus, Type 2
Conditions
Brief summary
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
Interventions
DRUGAcarbose
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
DRUGMetformin
500 mg 3 times daily, oral, with the first mouthful of main meal
DRUGPlacebo
Acarbose matching placebo, oral
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in the levels of glycosylated hemoglobin (HbA1c) | At baseline and at treatment week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 2-hour postprandial plasma glucose (PPG) | At baseline and at treatment week 16 | — |
| Change in fasting plasma glucose (FPG) levels | At baseline and at treatment week 16 | — |
| Responder rates | At week 16 | Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) \< 7%, and 2) \< 6.5% |
| Change in insulin resistance score | At baseline and at treatment week 16 | Insulin resistance score was calculated based on the homeostasis model assessment (HOMA) model: fasting plasma glucose in mmol/l \* fasting serum insulin in mU/L / 22.5. |
| Number of participants with adverse events | Up to 16 weeks | — |
| Change in fasting serum insulin levels | At baseline and at treatment week 16 | — |
Countries
China
Outcome results
None listed