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

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Acarbose; Drug: Metformin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital CAMS
  • Beijing, China, 101200
    • Beijing Pinggu Hospital
  • Beijing, China, 100028
    • Emergency General Hospital
  • Changsha, China, 410004
    • Changsha Central Hospital
  • Pingxiang, China, 337055
    • Jiangxi Pingxiang People's Hospital
  • Shanghai, China, 200072
    • Shanghai Tenth People's Hospital
  • Tianjin, China, 300121
    • Tianjin Union Medicine Centre (People's Hospital of Tianjin)
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
    • Guangzhou, Guangdong, China, 510150
      • The 3rd Affiliated Hospital of Guangzhou Medical University
  • Hainan
    • Haikou, Hainan, China, 570311
      • The Second Affliated Hospital of Hainan Medical University
    • Sanya, Hainan, China, 572000
      • Hainan Third People's Hospital (Province Nongken Sanya Hopt)
  • Henan
    • Luoyang, Henan, China, 471000
      • 1st Affiliated Hospital of Henan Science and Technology Univ
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Shiyan, Hubei, China, 442008
      • Taihe Hospital
    • Wuhan, Hubei, China, 430030
      • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
  • Hunan
    • Chenzhou, Hunan, China, 423000
      • Chenzhou NO. 1 people's Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
    • Huai'An, Jiangsu, China, 223300
      • Huai'an First People's Hospital, Nanjing Medical University
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Jilin Province People's Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • 1st Affiliated Hospital of Xi'an Jiaotong Medical University
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital
    • Jining, Shandong, China, 272000
      • Affiliated Hospital of Jining Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Xinjiang
    • Urumqi, Xinjiang, China, 830001
      • People's Hospital of Xinjiang Uygur Autonomous Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acarbose plus metformin arm; Participants received loose combination of acarbose and metformin 3 times daily.	Drug: Acarbose; 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; Drug: Metformin; 500 mg 3 times daily, oral, with the first mouthful of main meal; Drug: Placebo; Acarbose matching placebo, oral
Active Comparator: Metformin plus placebo arm; Participants received loose combination of placebo and metformin 3 times daily.	Drug: Metformin; 500 mg 3 times daily, oral, with the first mouthful of main meal; Drug: Placebo; Acarbose matching placebo, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change in the levels of glycosylated hemoglobin (HbA1c)	At baseline and at treatment week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rates	Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5%	At week 16
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
Change in fasting serum insulin levels		At baseline and at treatment week 16
Change in insulin resistance score	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.	At baseline and at treatment week 16
Number of participants with adverse events		Up to 16 weeks

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): August 12, 2019
• Study Completion (Actual): August 21, 2019

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Metformin; Acarbose
• Other Study ID Numbers: 17886

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No