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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cheng-Kung University Hospital
• Treatments: Hypoglycemic Agents; Repaglinide

Criteria

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