Status:
UNKNOWN
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
Lead Sponsor:
National Cheng-Kung University Hospital
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief 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.
Detailed 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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00336310
Start Date
July 1 2006
Last Update
June 13 2006
Active Locations (2)
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1
National Cheng-Kung University Hospital
Tainan, Taiwan, 704
2
National Cheng-Kung University Hospital
Tainan, Taiwan, 704