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Completed

NCT Number: NCT03349684

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

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

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acarbose

Drug

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

metformin

Drug

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

Placebo

Drug

Acarbose matching placebo, oral

Primary outcomes

  1. Absolute change in the levels of glycosylated hemoglobin (HbA1c)

    Time frame: At baseline and at treatment week 16

Secondary outcomes

  1. Responder rates

    Time frame: 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%

  2. Change in 2-hour postprandial plasma glucose (PPG)

    Time frame: At baseline and at treatment week 16

  3. Change in fasting plasma glucose (FPG) levels

    Time frame: At baseline and at treatment week 16

  4. Change in fasting serum insulin levels

    Time frame: At baseline and at treatment week 16

  5. Change in insulin resistance score

    Time frame: 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.

  6. Number of participants with adverse events

    Time frame: Up to 16 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blinded, Monotherapy-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of the Acarbose and Metformin in Loose-Dose Combination Compared to Metformin Monotherapy in Subjects WithType 2 Diabetic Mellitus (T2DM) That is Inadequately Controlled by Metformin Monotherapy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2017
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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