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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Acarbose; Drug: Mitiglinide

• Registration Number: NCT02143765
• Lead Sponsor: Zhongda Hospital

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.

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-03
• Study First Submitted QC: 2014-05-17
• Study First Posted: 2014-05-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acarbose	Acarbose	Acarbose 50 mg three times a day, orally, for 12 weeks
Mitiglinide	Mitiglinide	Mitiglinide 10 mg three times a day, orally, for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12	Baseline and Week 12

Secondary Outcome Measures

Name	Time	Method
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	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	baseline and 12 weeks	measured by Diabetes specific Quality of Life scale (DSQL) at baseline and 12 weeks
Treatment compliance	up to 12 weeks
Diabetes Treatment Satisfaction	12 weeks	measured by Diabetes Treatment Satisfaction Questionnaire (DTSQs) at 12 weeks

Trial Locations

Locations (6)

The First People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China

The Second People's Hospital of Huai'an; 🇨🇳 Huai'an, 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

Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University; 🇨🇳 Nanjing, Jiangsu, China