Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

— Match-101  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143765
• Other study ID #: ZhongdaH-Match
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2014
• Last updated: July 13, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Mitiglinide
three times a day, orally, for 12 weeks
• Acarbose
three times a day, orally, for 12 weeks

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

References & 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.

Zhu 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.c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12		Baseline and Week 12	No
Secondary	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	No
Secondary	Number of Participants with Serious and Non-Serious Adverse Events	Adverse events will be collected and followed in order to evaluate safety and tolerability	up to 12 weeks	Yes
Secondary	the change from baseline to the end of treatment in Diabetes Quality of Life	measured by Diabetes specific Quality of Life scale (DSQL) at baseline and 12 weeks	baseline and 12 weeks	No
Secondary	Treatment compliance		up to 12 weeks	No
Secondary	Diabetes Treatment Satisfaction	measured by Diabetes Treatment Satisfaction Questionnaire (DTSQs) at 12 weeks	12 weeks	No