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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03349684
Collaborator
(none)
287
Enrollment
29
Locations
2
Arms
17.5
Actual Duration (Months)
9.9
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
287 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 5, 2018
Actual Primary Completion Date :
Aug 12, 2019
Actual Study Completion Date :
Aug 21, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Absolute change in the levels of glycosylated hemoglobin (HbA1c) [At baseline and at treatment week 16]

Secondary Outcome Measures

  1. 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%

  2. Change in 2-hour postprandial plasma glucose (PPG) [At baseline and at treatment week 16]

  3. Change in fasting plasma glucose (FPG) levels [At baseline and at treatment week 16]

  4. Change in fasting serum insulin levels [At baseline and at treatment week 16]

  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.

  6. Number of participants with adverse events [Up to 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial Hospital Hefei Anhui China 230001
2 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China 230022
3 The First Affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong China 510080
4 Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ. Guangzhou Guangdong China 510120
5 The 3rd Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510150
6 The Second Affliated Hospital of Hainan Medical University Haikou Hainan China 570311
7 Hainan Third People's Hospital (Province Nongken Sanya Hopt) Sanya Hainan China 572000
8 1st Affiliated Hospital of Henan Science and Technology Univ Luoyang Henan China 471000
9 The first affiliated hospital of Zhengzhou University Zhengzhou Henan China 450052
10 Taihe Hospital Shiyan Hubei China 442008
11 Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. Wuhan Hubei China 430030
12 Chenzhou No. 1 People's Hospital Chenzhou Hunan China 423000
13 1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ Changzhou Jiangsu China 213003
14 Huai'an First People's Hospital, Nanjing Medical University Huai'An Jiangsu China 223300
15 Jiangsu Province Hospital Nanjing Jiangsu China 210029
16 Northern Jiangsu People's Hospital Yangzhou Jiangsu China 225001
17 Jilin Province People's Hospital Changchun Jilin China 130021
18 1st Affiliated Hospital of Xi'an Jiaotong Medical University Xi'an Shaanxi China 710061
19 Shandong Provincial Hospital Jinan Shandong China 250021
20 Affiliated Hospital of Jining Medical University Jining Shandong China 272000
21 West China Hospital, Sichuan University Chengdu Sichuan China 610041
22 People's Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang China 830001
23 Emergency General Hospital Beijing China 100028
24 Peking Union Medical College Hospital CAMS Beijing China 100730
25 Beijing Pinggu Hospital Beijing China 101200
26 Changsha Central Hospital Changsha China 410004
27 Jiangxi PingXiang people's Hospital Pingxiang China 337055
28 Shanghai Tenth People's Hospital Shanghai China 200072
29 Tianjin Union Medicine Centre (People's Hospital of Tianjin) Tianjin China 300121

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03349684
Other Study ID Numbers:
  • 17886
First Posted:
Nov 21, 2017
Last Update Posted:
Aug 5, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Metformin
Acarbose

Study Results

No Results Posted as of Aug 5, 2020