Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus (Match-101)

July 13, 2016 updated by: Zilin Sun, Zhongda Hospital

An Open, Multi-center, Randomized Study to Evaluate the Efficacy and Safety of Mitiglinide Versus Acarbose in Patients With Type 2 Diabetes Mellitus in China

Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial hyperglycemia and improves overall glycemic control.

This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in patients with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Group I (Mitiglinide): Mitiglinide 10 mg three times a day, orally, for 12 weeks Group II (Acarbose): Acarbose 50 mg three times a day, orally, for 12 weeks Total subjects: 248, randomized to 2 groups at ratio of 1:1.

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China
        • The First People's Hospital of Changzhou
      • Huai'an, Jiangsu, China
        • The Second People's Hospital of Huai'an
      • Nanjing, Jiangsu, China
        • Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
      • Xuzhou, Jiangsu, China
        • XuZhou Central Hospital
      • Yancheng, Jiangsu, China
        • Yancheng City NO.1 People's Hospital
      • Zhenjiang, Jiangsu, China
        • Zhenjiang First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects aged between 18 and 70, regardless of gender
  2. Subjects with type-2 diabetes mellitus diagnosed according to 1999 WHO criteria within 5 years
  3. Subjects who had not received insulin secretagogues, insulin sensitizers, incretin mimetics or alpha-glucosidase inhibitors
  4. Subjects whose fasting blood glucose [FBG] between7.0 and10.0 mmol/L and HbA1c ratio is between 7.0% and 10.0%

Note: Incretin mimetics contain glucagon-like peptide 1 (GLP-1) receptor agonist (including GLP-1 analogues) and dipeptidyl peptidase 4 inhibitors.

Exclusion Criteria:

  1. Subjects with abnormal hepatic function whose aspartate transaminase (AST) and alanine transaminase (ALT) are 2 times higher than the upper limits of normal (ULN)
  2. Subjects with renal disfunction whose plasma creatinine concentration are more than 1.1 ULN or positive urine protein
  3. Subjects with severe heart disease, liver diseases, kidney disease and other serious organic disease
  4. Subjects who have chronic intestinal diseases associated with marked disorders of digestion or absorption and may deteriorate as a result of increased gas formation in the intestine (like Gastrocardiac Syndrome, severe hernia, intestinal obstruction, intestinal ulcer and intestinal surgery)
  5. Subjects with endocrine system diseases such as hyperthyroidism and cushing's syndrome etc.
  6. Subject is contraindicated or hypersensitivity to both experimental drugs or comparator drugs
  7. Subjects who participated in other clinical studies as subjects within 3 months before this study
  8. Female subjects who have been pregnant , lactating or without contraception in childbearing potential
  9. Subjects judged unfit for this study by investigators

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mitiglinide
Mitiglinide 10 mg three times a day, orally, for 12 weeks
Drug: Mitiglinide
three times a day, orally, for 12 weeks
Other Names:
  • FADI
Active Comparator: Acarbose
Acarbose 50 mg three times a day, orally, for 12 weeks
Drug: Acarbose
three times a day, orally, for 12 weeks
Other Names:
  • PRECOSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change from baseline to the end of treatment in fasting blood glucose (FBG), postprandial blood glucose (PBG)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Baseline, 4 weeks, 8 weeks, 12 weeks
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: up to 12 weeks
Adverse events will be collected and followed in order to evaluate safety and tolerability
up to 12 weeks
the change from baseline to the end of treatment in Diabetes Quality of Life
Time Frame: baseline and 12 weeks
measured by Diabetes specific Quality of Life scale (DSQL) at baseline and 12 weeks
baseline and 12 weeks
Treatment compliance
Time Frame: up to 12 weeks
up to 12 weeks
Diabetes Treatment Satisfaction
Time Frame: 12 weeks
measured by Diabetes Treatment Satisfaction Questionnaire (DTSQs) at 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 3, 2014

First Submitted That Met QC Criteria

May 17, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhongdaH-Match

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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