Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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
NCT number | NCT00336310 |
Other study ID # | YSRE0001 |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 4 |
First received | June 12, 2006 |
Last updated | June 12, 2006 |
Start date | July 2006 |
The purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng-Kung University Hospital | Tainan | |
Taiwan | National Cheng-Kung University Hospital | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of HbA1c at 12 weeks | |||
Primary | Change of fasting plasma glucose (FPG) at 12 weeks | |||
Primary | Change of postprandial plasma glucose (PPG) at 12 weeks | |||
Secondary | Safety parameters including adverse events such as hypoglycemia | |||
Secondary | change of liver and renal function test |
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