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Study of the Durability of Glycemic Control With Nateglinide

This study is currently recruiting participants.
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
History of Changes

March 6, 2009
June 24, 2011
April 2009
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00858013 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study of the Durability of Glycemic Control With Nateglinide
Multi-center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients

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

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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Nateglinide
    Nateglinide 90~120mg three times a day
    Other Name: fastic
  • Drug: Glimepiride
    Glimepiride 1~2mg once a day
    Other Name: amaryl
  • Active Comparator: Nateglinide
    Nateglinide 90~120mg three times a day
    Intervention: Drug: Nateglinide
  • Active Comparator: Glimepiride
    Glimepiride 1~2mg once a day
    Intervention: Drug: Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Korea, Republic of
 
NCT00858013
AJIRB-CRO-08-197
Yes
Kwan Woo Lee/ Chief of the Department of Endocrinology and Metabolism, Ajou University
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
Principal Investigator: Kwan Woo Lee, MD,PhD Ajou University School of Medicine
Ajou University School of Medicine
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP