Study of the Durability of Glycemic Control With Nateglinide

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Ajou University School of Medicine
Sponsor:
Collaborators:
Korea University Guro Hospital
Hanyang University
Inha University Hospital
Kyunghee University Medical Center
Myongji Hospital
Bundang CHA Hospital
Yonsei University
Hallym University Medical Center
Information provided by:
Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT00858013
First received: March 6, 2009
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Nateglinide
Drug: Glimepiride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • The durability of nateglinide in comparison with those of glimepiride based on the withdrawal rate [ Time Frame: every 3 months following randomization, for 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. HbA1c, Fasting blood sugar, 2hours postprandial blood sugar 2. insulin secretion(C-peptide), insulin sensitivity(HOMA-IR), lipid profile [ Time Frame: every 3 months following randomization, for 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nateglinide
Nateglinide 90~120mg three times a day
Drug: Nateglinide
Nateglinide 90~120mg three times a day
Other Name: fastic
Active Comparator: Glimepiride
Glimepiride 1~2mg once a day
Drug: Glimepiride
Glimepiride 1~2mg once a day
Other Name: amaryl

Detailed Description:

Selected patients will be randomly assigned to receive nateglinide or glimepiride.

Previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor, nateglinide or sulfonylurea) will be discontinued. After a 1 month wash-out period (if 6.5 ≤ HbA1c ≤ 8.5), patients will take randomly assigned drugs for 24 months.

Patients will be met by the trial investigator every 3 months following randomization. At each visit, patients whose HbA1c is > 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure. We will evaluate the durability of nateglinide in comparison with that of glimepiride based on the withdrawal rate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus
  • age>=18years
  • no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy

    • metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea <6months)
  • 6.5% ≤ HbA1c ≤ 8.5%

    • patients on no anti hyperglycemic agent for 3 months : HbA1c at screening
    • patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out

Exclusion Criteria:

  • attending other clinical trials in 3months
  • type I diabetes mellitus
  • taking systemic steroid in 1month or requiring steroid therapy during clinical trial
  • acute myocardial infarction in 6months
  • alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
  • severe liver disease or AST, ALT ≥ 2.5 x ULN
  • renal insufficiency (serum creatinine > 2.0mg/dl)
  • other severe diabetic complication
  • drug hypersensitivity history to nateglinide or sulfonylurea
  • pregnant or plan to become pregnant during the clinical trial, lactation
  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: NCT00858013

Contacts
Contact: Kwan Woo Lee, MD, PhD 82-31-219-4526 lkw65@ajou.ac.kr
Contact: Hae Jin Kim, MD, PhD 82-31-219-4498 jinkim@ajou.ac.kr

Locations
Korea, Republic of
Myongji Hospital Recruiting
Ilsan, Kyounggi, Korea, Republic of
Contact: Tae-Ho Kim         
Hanyang University Medical Center Recruiting
Kuri, Kyunggi-do, Korea, Republic of
Contact: Yongsoo Park, MD, PhD    82-31-553-7369    parkys@hanyang.ac.kr   
Principal Investigator: Yongsoo Park, MD,PhD         
Inha University Hospital Recruiting
In Cheon, Korea, Republic of
Contact: Moon-Suk Nam, MD, PhD    82-32-890-3495    namms@inha.ac.kr   
Principal Investigator: Moon-Suk Nam, MD,PhD         
Kyung hee University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Young-Seol Kim, MD,PhD    82-2-958-8128    kimys@khmc.or.kr   
Principal Investigator: Young-Seol Kim, MD,PhD         
Hallym University Medical Center Recruiting
Seoul, Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sei Hyun Baik, MD, PhD    82-2-818-6645    103hyun@korea.ac.kr   
Principal Investigator: Sei Hyun Baik, MD, PhD         
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Hae Jin Kim, MD, PhD    82-31-219-4498    jinkim@ajou.ac.kr   
Contact: Kwan Woo Lee, MD, PhD    82-31-219-4526    lkw65@ajou.ac.kr   
Principal Investigator: Kwan Woo Lee, MD, PhD         
Sub-Investigator: Dae Jung Kim, MD         
Sub-Investigator: Hae Jin Kim, MD, PhD         
Sub-Investigator: Seung Jin Han, MD         
Sub-Investigator: Tae Ho Kim, MD         
Sponsors and Collaborators
Ajou University School of Medicine
Korea University Guro Hospital
Hanyang University
Inha University Hospital
Kyunghee University Medical Center
Myongji Hospital
Bundang CHA Hospital
Yonsei University
Hallym University Medical Center
Investigators
Principal Investigator: Kwan Woo Lee, MD,PhD Ajou University School of Medicine
  More Information

No publications provided

Responsible Party: Kwan Woo Lee/ Chief of the Department of Endocrinology and Metabolism, Ajou University
ClinicalTrials.gov Identifier: NCT00858013     History of Changes
Other Study ID Numbers: AJIRB-CRO-08-197
Study First Received: March 6, 2009
Last Updated: June 24, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ajou University School of Medicine:
Type 2 Diabetes Mellitus
Nateglinide
Pancreatic beta cell function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Nateglinide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 16, 2014