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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Acarbose
Metformin
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Anhui Provincial Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Sun Yat-Sen University
  • Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
  • The 3rd Affiliated Hospital of Guangzhou Medical University
  • The Second Affliated Hospital of Hainan Medical University
  • Hainan Third People's Hospital (Province Nongken Sanya Hopt)
  • 1st Affiliated Hospital of Henan Science and Technology Univ
  • The first affiliated hospital of Zhengzhou University
  • Taihe Hospital
  • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
  • Chenzhou No. 1 People's Hospital
  • 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
  • Huai'an First People's Hospital, Nanjing Medical University
  • Jiangsu Province Hospital
  • Northern Jiangsu People's Hospital
  • Jilin Province People's Hospital
  • 1st Affiliated Hospital of Xi'an Jiaotong Medical University
  • Shandong Provincial Hospital
  • Affiliated Hospital of Jining Medical University
  • West China Hospital, Sichuan University
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Emergency General Hospital
  • Peking Union Medical College Hospital CAMS
  • Beijing Pinggu Hospital
  • Changsha Central Hospital
  • Jiangxi PingXiang people's Hospital
  • Shanghai Tenth People's Hospital
  • Tianjin Union Medicine Centre (People's Hospital of Tianjin)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acarbose plus metformin arm

Metformin plus placebo arm

Arm Description

Participants received loose combination of acarbose and metformin 3 times daily.

Participants received loose combination of placebo and metformin 3 times daily.

Outcomes

Primary Outcome Measures

Absolute change in the levels of glycosylated hemoglobin (HbA1c)

Secondary Outcome Measures

Responder rates
Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5%
Change in 2-hour postprandial plasma glucose (PPG)
Change in fasting plasma glucose (FPG) levels
Change in fasting serum insulin levels
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.
Number of participants with adverse events

Full Information

First Posted
November 17, 2017
Last Updated
August 3, 2020
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03349684
Brief Title
Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acarbose plus metformin arm
Arm Type
Experimental
Arm Description
Participants received loose combination of acarbose and metformin 3 times daily.
Arm Title
Metformin plus placebo arm
Arm Type
Active Comparator
Arm Description
Participants received loose combination of placebo and metformin 3 times daily.
Intervention Type
Drug
Intervention Name(s)
Acarbose
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
500 mg 3 times daily, oral, with the first mouthful of main meal
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Acarbose matching placebo, oral
Primary Outcome Measure Information:
Title
Absolute change in the levels of glycosylated hemoglobin (HbA1c)
Time Frame
At baseline and at treatment week 16
Secondary Outcome Measure Information:
Title
Responder rates
Description
Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5%
Time Frame
At week 16
Title
Change in 2-hour postprandial plasma glucose (PPG)
Time Frame
At baseline and at treatment week 16
Title
Change in fasting plasma glucose (FPG) levels
Time Frame
At baseline and at treatment week 16
Title
Change in fasting serum insulin levels
Time Frame
At baseline and at treatment week 16
Title
Change in insulin resistance score
Description
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.
Time Frame
At baseline and at treatment week 16
Title
Number of participants with adverse events
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The 3rd Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510150
Country
China
Facility Name
The Second Affliated Hospital of Hainan Medical University
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Hainan Third People's Hospital (Province Nongken Sanya Hopt)
City
Sanya
State/Province
Hainan
ZIP/Postal Code
572000
Country
China
Facility Name
1st Affiliated Hospital of Henan Science and Technology Univ
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Facility Name
The first affiliated hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Taihe Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442008
Country
China
Facility Name
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Chenzhou No. 1 People's Hospital
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Facility Name
1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Huai'an First People's Hospital, Nanjing Medical University
City
Huai'An
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
1st Affiliated Hospital of Xi'an Jiaotong Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
Emergency General Hospital
City
Beijing
ZIP/Postal Code
100028
Country
China
Facility Name
Peking Union Medical College Hospital CAMS
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Pinggu Hospital
City
Beijing
ZIP/Postal Code
101200
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
ZIP/Postal Code
410004
Country
China
Facility Name
Jiangxi PingXiang people's Hospital
City
Pingxiang
ZIP/Postal Code
337055
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
City
Tianjin
ZIP/Postal Code
300121
Country
China

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products

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

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