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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by National Cheng-Kung University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT00336310
First received: June 12, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Tainan, Taiwan, 704
Sub-Investigator: H-Y Ou, MD         
National Cheng-Kung University Hospital Not yet recruiting
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

No publications provided

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

Keywords provided by National Cheng-Kung University Hospital:
Diabetes Mellitus
Treatment
Repaglinide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014