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

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Bayer

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Acarbose
Drug: Metformin
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

287 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

287 participants in 2 patient groups

Acarbose plus metformin arm
Experimental group
Description:
Participants received loose combination of acarbose and metformin 3 times daily.
Treatment:
Drug: Acarbose
Drug: Metformin
Drug: Placebo
Metformin plus placebo arm
Active Comparator group
Description:
Participants received loose combination of placebo and metformin 3 times daily.
Treatment:
Drug: Metformin
Drug: Placebo

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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