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Study of the Durability of Glycemic Control With Nateglinide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00858013
First Posted: March 9, 2009
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Korea University Guro Hospital
Hanyang University
Inha University Hospital
Kyunghee University Medical Center
Myongji Hospital
Bundang CHA Hospital
Wonju Severance Christian Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
Kwan Woo Lee, Ajou University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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 Kwan Woo Lee, 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 ]
    % monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)


Secondary Outcome Measures:
  • HbA1c [ Time Frame: at 24 months ]
    HbA1c (%) at 24 months

  • Fasting Glucose [ Time Frame: at 24 months ]
    fasting glucose (mg/dL) at 24 months

  • C-peptide [ Time Frame: at 24 months ]
    c-peptide(uU/mL) at 24 months

  • HOMA-IR [ Time Frame: at 24 months ]
    insulin resistance marker HOMA-IR at 24 months


Enrollment: 88
Actual Study Start Date: April 24, 2009
Study Completion Date: June 25, 2014
Primary Completion Date: June 25, 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858013


Locations
Korea, Republic of
Myongji Hospital
Ilsan, Kyounggi, Korea, Republic of
Hanyang University Medical Center
Guri-si, Kyunggi-do, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Hallym University Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Kyung hee University Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon-si, Korea, Republic of
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
Wonju Severance Christian Hospital
Hallym University Medical Center
Investigators
Principal Investigator: Kwan Woo Lee, MD,PhD Ajou University School of Medicine
  More Information

Responsible Party: Kwan Woo Lee, Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT00858013     History of Changes
Other Study ID Numbers: AJIRB-CRO-08-197
First Submitted: March 6, 2009
First Posted: March 9, 2009
Results First Submitted: February 14, 2017
Results First Posted: March 31, 2017
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kwan Woo Lee, 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
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors