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

This study is not yet open for participant recruitment.

Verified by National Cheng-Kung University Hospital, June 2006

Sponsored by:	National Cheng-Kung University Hospital
Information provided by:	National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:	NCT00336310

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Repaglinide	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: AG-EE 388 ZW

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:

change of HbA1c at 12 weeks
Change of fasting plasma glucose (FPG) at 12 weeks
Change of postprandial plasma glucose (PPG) at 12 weeks

Secondary Outcome Measures:

Safety parameters including adverse events such as hypoglycemia
change of liver and renal function test

Estimated Enrollment:	50
Study Start Date:	July 2006

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 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.

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336310

Contacts

Contact: H.Y. Ou, MD	886-6-2353535 ext 2177	wahoryi@mail.ncku.edu.tw
Contact: T.J. Wu, MD	886-6-2353535 ext 5387	djwu@mail.ncku.edu.tw

Locations

Taiwan
National Cheng-Kung University Hospital
Tainan, Taiwan, 704
National Cheng-Kung University Hospital
Tainan, Taiwan, 704

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

Principal Investigator:

T-J Wu, MD

National Cheng-Kung University Hospital

More Information

Study ID Numbers:	YSRE0001
Study First Received:	June 12, 2006
Last Updated:	June 12, 2006
ClinicalTrials.gov Identifier:	NCT00336310
Health Authority:	Taiwan: Department of Health, Executive Yuan

Keywords provided by National Cheng-Kung University Hospital:

Diabetes Mellitus
Treatment
Repaglinide

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Repaglinide

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009