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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00336310
• Date of registration: 12/06/2006
• Prospective Registration: Yes
• Primary sponsor: National Cheng-Kung University Hospital
• Public 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
• Scientific 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
• Date of first enrolment: July 2006
• Target sample size: 50
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00336310
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Taiwan

Contacts

• Name: H.Y. Ou, MD

• Name: T-J Wu, MD
• Affiliation: National Cheng-Kung University Hospital

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Repaglinide

Primary Outcome(s)

Change of postprandial plasma glucose (PPG) at 12 weeks

change of HbA1c at 12 weeks

Change of fasting plasma glucose (FPG) at 12 weeks

Secondary Outcome(s)

change of liver and renal function test

Safety parameters including adverse events such as hypoglycemia

Secondary ID(s)

YSRE0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors