Clinical trial NCT02143765: Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Mitiglinide
Acarbose
Type 2 Diabetes Mellitus
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: the change from baseline to the end of treatment in fasting blood glucose (FBG), postprandial blood glucose (PBG)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: up to 12 weeks
measure: the change from baseline to the end of treatment in Diabetes Quality of Life
timeFrame: baseline and 12 weeks
measure: Treatment compliance
timeFrame: up to 12 weeks
measure: Diabetes Treatment Satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Huai'an
country: China
facility: The Second People's Hospital of Huai'an
state: Jiangsu
city: Nanjing
country: China
facility: Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng City No.1 People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Zhenjiang First People's Hospital
state: Jiangsu
Study officials:
References:
citation: 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.
citation: 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.clinthera.2013.03.020. Epub 2013 Apr 18.