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

Southeast University

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Mitiglinide; Drug: Acarbose

Study type: Interventional

Funder types: Other

Identifiers

NCT02143765

ZhongdaH-Match

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

248 participants in 2 patient groups

Mitiglinide

Experimental group

Description:

Mitiglinide 10 mg three times a day, orally, for 12 weeks

Treatment:

Drug: Mitiglinide

Acarbose

Active Comparator group

Description:

Acarbose 50 mg three times a day, orally, for 12 weeks

Treatment:

Drug: Acarbose