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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Mitiglinide
* Drug: Acarbose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitiglinide<br>Mitiglinide 10 mg three times a day, orally, for 12 weeks | Drug: Mitiglinide<br>* three times a day, orally, for 12 weeks<br>* Other names: FADI;|
| Active Comparator: Acarbose<br>Acarbose 50 mg three times a day, orally, for 12 weeks | Drug: Acarbose<br>* three times a day, orally, for 12 weeks<br>* Other names: PRECOSE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 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) |  | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| 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 | 
| 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 | 
| Treatment compliance |  | up to 12 weeks | 
| Diabetes Treatment Satisfaction | measured by Diabetes Treatment Satisfaction Questionnaire (DTSQs) at 12 weeks | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Mitiglinide, Acarbose