Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus
Match-101
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
1 other identifier
interventional
248
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started May 2014
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 3, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 14, 2016
July 1, 2016
1.6 years
May 3, 2014
July 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Baseline and Week 12
Secondary Outcomes (5)
the change from baseline to the end of treatment in fasting blood glucose (FBG), postprandial blood glucose (PBG)
Baseline, 4 weeks, 8 weeks, 12 weeks
Number of Participants with Serious and Non-Serious Adverse Events
up to 12 weeks
the change from baseline to the end of treatment in Diabetes Quality of Life
baseline and 12 weeks
Treatment compliance
up to 12 weeks
Diabetes Treatment Satisfaction
12 weeks
Study Arms (2)
Mitiglinide
EXPERIMENTALMitiglinide 10 mg three times a day, orally, for 12 weeks
Acarbose
ACTIVE COMPARATORAcarbose 50 mg three times a day, orally, for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Subjects aged between 18 and 70, regardless of gender
- Subjects with type-2 diabetes mellitus diagnosed according to 1999 WHO criteria within 5 years
- Subjects who had not received insulin secretagogues, insulin sensitizers, incretin mimetics or alpha-glucosidase inhibitors
- 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.
You may not qualify if:
- Subjects with abnormal hepatic function whose aspartate transaminase (AST) and alanine transaminase (ALT) are 2 times higher than the upper limits of normal (ULN)
- Subjects with renal disfunction whose plasma creatinine concentration are more than 1.1 ULN or positive urine protein
- Subjects with severe heart disease, liver diseases, kidney disease and other serious organic disease
- 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)
- Subjects with endocrine system diseases such as hyperthyroidism and cushing's syndrome etc.
- Subject is contraindicated or hypersensitivity to both experimental drugs or comparator drugs
- Subjects who participated in other clinical studies as subjects within 3 months before this study
- Female subjects who have been pregnant , lactating or without contraception in childbearing potential
- Subjects judged unfit for this study by investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (6)
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The Second People's Hospital of Huai'an
Huai'an, Jiangsu, China
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Yancheng City No.1 People's Hospital
Yancheng, Jiangsu, China
Zhenjiang First People's Hospital
Zhenjiang, Jiangsu, China
Related Publications (2)
LV Xiaofeng. Clinical study on efficacy and safety of mitiglinide on type 2 diabetes mellitus. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(2):175-179.
RESULTZhu Q, Tong Y, Wu T, Li J, Tong N. Comparison of the hypoglycemic effect of acarbose monotherapy in patients with type 2 diabetes mellitus consuming an Eastern or Western diet: a systematic meta-analysis. Clin Ther. 2013 Jun;35(6):880-99. doi: 10.1016/j.clinthera.2013.03.020. Epub 2013 Apr 18.
PMID: 23602502RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Department of Endocrinology, Zhongda Hospital, Institute of Diabetes
Study Record Dates
First Submitted
May 3, 2014
First Posted
May 21, 2014
Study Start
May 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 14, 2016
Record last verified: 2016-07