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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Zhongda Hospital
Sponsor:
Information provided by (Responsible Party):
Zilin Sun, Zhongda Hospital
ClinicalTrials.gov Identifier:
NCT02143765
First received: May 3, 2014
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Mitiglinide
Drug: Acarbose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Zhongda Hospital:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability

  • the change from baseline to the end of treatment in Diabetes Quality of Life [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    measured by Diabetes specific Quality of Life scale (DSQL) at baseline and 12 weeks

  • Treatment compliance [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Diabetes Treatment Satisfaction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    measured by Diabetes Treatment Satisfaction Questionnaire (DTSQs) at 12 weeks


Estimated Enrollment: 248
Study Start Date: May 2014
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mitiglinide
Mitiglinide 10 mg three times a day, orally, for 12 weeks
Drug: Mitiglinide
Other Name: FADI
Active Comparator: Acarbose
Acarbose 50 mg three times a day, orally, for 12 weeks
Drug: Acarbose
Other Name: PRECOSE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02143765

Contacts
Contact: Zilin Sun +83-025-83262818 sunzilin1963@126.com

Locations
China, Jiangsu
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University Recruiting
Nanjing, Jiangsu, China
Contact: Zilin Sun    +82-025-83262818    sunzilin1963@126.com   
Principal Investigator: Zilin Sun         
Sub-Investigator: Yang Yuan         
Sponsors and Collaborators
Zhongda Hospital
  More Information

Publications:
Responsible Party: Zilin Sun, Chief of Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT02143765     History of Changes
Other Study ID Numbers: ZhongdaH-Match
Study First Received: May 3, 2014
Last Updated: June 6, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Zhongda Hospital:
Mitiglinide
Acarbose
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
Mitiglinide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014