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

NCT00336310 | Unknown Phase 4

• 1 other identifier: YSRE0001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; Treatment; Repaglinide

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Safety parameters including adverse events such as hypoglycemia

• change of liver and renal function test

Interventions

Repaglinide DRUG

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (2)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

repaglinide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• T-J Wu, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

H.Y. Ou, MD

CONTACT

886-6-2353535; wahoryi@mail.ncku.edu.tw

T.J. Wu, MD

CONTACT

886-6-2353535; djwu@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 12, 2006
• First Posted: June 13, 2006
• Study Start: July 1, 2006
• Last Updated: June 13, 2006

Record last verified: 2006-06

Locations

TW (2)