check_circleStudy Completed

Diabetes mellitus, Type 2

Bayer Identifier:

17886

ClinicalTrials.gov Identifier:

NCT03349684

EudraCT Number:

Not Available

EU CT Number:

Not Available
Loose-dose combination of acarbose and metformin for T2DM in metformin-failure patients

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - 79 Years
  • -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
  • -Fasting plasma glucose > 14.0 mmol/L
    -Severe metabolic diabetic complications

Trial summary

Enrollment Goal
287
Trial Dates
March 2018 - August 2019
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Glucobay M (Acarbose/Metformin, BAY81-9783)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Shandong Provincial HospitalJinan, 250021, China
Withdrawn
The First Affiliated Hospital of Wannan Medical collegeWuhu, 241001, China
Completed
The First Affiliated Hospital of Anhui Medical UniversityHefei, 230022, China
Completed
Anhui Provincial HospitalHefei, 230001, China
Completed
Emergency General HospitalBeijing, 100028, China
Withdrawn
The Affiliated Hospital of Xuzhou Medical CollegeXuzhou, 221351, China
Completed
Huai'an First People's Hospital, Nanjing Medical UniversityHuai'An, 223300, China
Completed
1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow UnivChangzhou, 213003, China
Completed
Jiangsu Province HospitalNanjing, 210029, China
Withdrawn
Jinan Central HospitalJinan, 250013, China
Withdrawn
General Hospital of Chinese Armed Police ForcesBeijing, 100039, China
Completed
Beijing Pinggu HospitalBeijing, 101200, China
Completed
Hainan Third People's Hospital (Province Nongken Sanya Hopt)Sanya, 572000, China
Completed
Changsha Central HospitalChangsha, 410004, China
Completed
Jiangxi PingXiang people's HospitalPingxiang, 337055, China
Completed
People's Hospital of Xinjiang Uygur Autonomous RegionUrumqi, 830001, China
Completed
Peking Union Medical College Hospital CAMSBeijing, 100730, China
Completed
Tianjin Union Medicine Centre (People's Hospital of Tianjin)Tianjin, 300121, China
Completed
1st Affiliated Hospital of Xi'an Jiaotong Medical UniversityXi'an, 710061, China
Completed
West China Hospital, Sichuan UniversityChengdu, 610041, China
Completed
The 3rd Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, 510150, China
Completed
The First Affiliated Hospital of Sun Yat-Sen Universityguangzhou, 510080, China
Withdrawn
2nd affiliated Hos. Harbin Medical UniversityHarbin, 150001, China
Withdrawn
Tangshan Gongren HospitalTangshan, 063000, China
Completed
Jilin Province People's HospitalChangchun, 130021, China
Completed
Northern Jiangsu People's HospitalYangzhou, 225001, China
Completed
Chenzhou No. 1 People's HospitalChenzhou, 423000, China
Completed
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.Wuhan, 430030, China
Completed
SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV.Guangzhou, 510120, China
Completed
The first affiliated hospital of Zhengzhou UniversityZhengzhou, 450052, China
Completed
Affiliated Hospital of Jining Medical UniversityJining, 272000, China
Completed
1st Affiliated Hospital of Henan Science and Technology UnivLuoyang, 471000, China
Completed
Taihe HospitalShiyan, 442008, China
Completed
The Second Affliated Hospital of Hainan Medical UniversityHaikou, 570311, China
Withdrawn
The 4th Affiliated Hospital of Harbin Medical UniversityHarbin, 150001, China
Completed
Shanghai Tenth People's HospitalShanghai, 200072, China

Primary Outcome

  • Absolute change in the levels of glycosylated hemoglobin (HbA1c)
    date_rangeTime Frame:
    At baseline and at treatment week 16

Secondary Outcome

  • Responder rates
    Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5%
    date_rangeTime Frame:
    At week 16
  • Change in 2-hour postprandial plasma glucose (PPG)
    date_rangeTime Frame:
    At baseline and at treatment week 16
  • Change in fasting plasma glucose (FPG) levels
    date_rangeTime Frame:
    At baseline and at treatment week 16
  • Change in fasting serum insulin levels
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    At baseline and at treatment week 16
  • Number of participants with adverse events
    date_rangeTime Frame:
    Up to 16 weeks

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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