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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Acarbose; Drug: Metformin; Drug: Placebo

• Registration Number: NCT03349684
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Study Start: 2018-03-05
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-21
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin plus placebo arm	Placebo	Participants received loose combination of placebo and metformin 3 times daily.
Acarbose plus metformin arm	Placebo	Participants received loose combination of acarbose and metformin 3 times daily.
Acarbose plus metformin arm	Acarbose	Participants received loose combination of acarbose and metformin 3 times daily.
Metformin plus placebo arm	Metformin	Participants received loose combination of placebo and metformin 3 times daily.
Acarbose plus metformin arm	Metformin	Participants received loose combination of acarbose and metformin 3 times daily.

Primary Outcome Measures

Name	Time	Method
Absolute change in the levels of glycosylated hemoglobin (HbA1c)	At baseline and at treatment week 16

Secondary Outcome Measures

Name	Time	Method
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%
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	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.
Number of participants with adverse events	Up to 16 weeks

Trial Locations

Locations (29)

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.; 🇨🇳 Guangzhou, Guangdong, China

The 3rd Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The Second Affliated Hospital of Hainan Medical University; 🇨🇳 Haikou, Hainan, China

Hainan Third People's Hospital (Province Nongken Sanya Hopt); 🇨🇳 Sanya, Hainan, China

1st Affiliated Hospital of Henan Science and Technology Univ; 🇨🇳 Luoyang, Henan, China

The first affiliated hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Taihe Hospital; 🇨🇳 Shiyan, Hubei, China

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