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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Nateglinide; Drug: Glimepiride

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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Hallym University Medical Center
  • Suwon-si, Korea, Republic of
    • Ajou University Hospital
  • Kyounggi
    • Ilsan, Kyounggi, Korea, Republic of
      • Myongji Hospital
  • Kyunggi-do
    • Guri-si, Kyunggi-do, Korea, Republic of
      • Hanyang University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nateglinide; Nateglinide 90~120mg three times a day	Drug: Nateglinide; Nateglinide 90~120mg three times a day; Other Names: fastic
Active Comparator: Glimepiride; Glimepiride 1~2mg once a day	Drug: Glimepiride; Glimepiride 1~2mg once a day; Other Names: amaryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate	% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)	every 3 months following randomization, for 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c (%) at 24 months	at 24 months
Fasting Glucose	fasting glucose (mg/dL) at 24 months	at 24 months
C-peptide	c-peptide(uU/mL) at 24 months	at 24 months
HOMA-IR	insulin resistance marker HOMA-IR at 24 months	at 24 months

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Collaborators: Korea University Guro Hospital; Hanyang University; Bundang CHA Hospital; Hallym University Medical Center; Wonju Severance Christian Hospital; Kyunghee University Medical Center; Inha University Hospital; Myongji Hospital
• Investigators: Principal Investigator: Kwan Woo Lee, MD,PhD, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2009
• Primary Completion (Actual): June 25, 2014
• Study Completion (Actual): June 25, 2014

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (Estimate): March 9, 2009

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Nateglinide; Pancreatic beta cell function
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Glimepiride; Nateglinide
• Other Study ID Numbers: AJIRB-CRO-08-197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO