A Double-Blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients

National Cheng-Kung University

Status and phase

Unknown

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Repaglinide

Study type

Interventional

Funder types

Other

Identifiers

NCT00336310

YSRE0001

Details and patient eligibility

About

The purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients.

Full description

This study is designed to evaluate the efficacy and safety of a new-brand of repaglinide X® in comparison to Novonorm® for the treatment of type 2 diabetes mellitus patients. Mentally competent patients with age of 30 to 75 years old in Taiwan of either sex with type 2 diabetes mellitus will be included. All eligible subjects will be randomized into treatment groups in 1:1 ratio. The treatment will consist of either X® or Novonorm® tid before meal for 12 weeks of treatment. The primary endpoints include the net change of HbA!c, fasting plasma glucose(FPG)and postprandial plasma glucose(PPG)at the end of 12th week evaluation compared to the baseline visit. Also, safety profiles including adverse event (such as hypoglycemia) incidences, blood pressure, liver, kidney function test will be monitored.

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Mentally competent adults of either sex with age 30-75 years old
Patients have type 2 diabetes mellitus diagnosed after 25 years of age
Patients have been in poor glycemic control by diet or exercise for at least 1 month or by a stable dose of metformin for at least 3 months before study; poor glycemic control is defined as: Glycosylated hemoglobin A1c (HbA1c) 7.1-11.0%
Patients have signed the written informed consent form

Exclusion criteria

Patients with type 1 diabetes mellitus (insulin¬dependent)
Patients taking medications possibly to affect significantly the intestinal motility or the absorption of nutrients.
Female patients who are pregnant or trying to become pregnant or lactating during the study
Patients with alcohol, drugs or medications abuse considered by the investigator
Patients with impaired liver function (AST, ALT>2.5× upper limit of normal)
Patients with impaired kidney function (serum creatinine>3.0 mg/dl)
Patients with unstable cardiovascular conditions (e.g., New York Heart Association functional class III or IV congestive heart failure or a history of myocardial infarction or stroke)
Patients with emphysema or chronic bronchitis
Patients with diabetic ketoacidosis
Patients with hepatic cirrhosis
Patients with on-going inflammatory bowel disease, colonic ulceration, partial intestinal obstruction
Patients are predisposed to intestinal obstruction
Patients with chronic intestinal diseases related to marked disorders of digestion or absorption
Patients with clinically significant medical conditions that may deteriorate clinically due to gastrointestinal gas increase
Patients with a history of lactic acidosis
Patients with a history of allergic to repaglinide
Patients took any hypoglycemic agent except for metformin within 3 months before study
Patients participated investigational drug trial within 1 month before entering this study
Patients with any other serious diseases considered by the investigator not in the condition to enter the trial