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Study of the Durability of Glycemic Control With Nateglinide

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nateglinide
Glimepiride
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Nateglinide, Pancreatic beta cell function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Myongji Hospital
  • Hanyang University Medical Center
  • Inha University Hospital
  • Hallym University Medical Center
  • Korea University Guro Hospital
  • Kyung hee University Medical Center
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nateglinide

Glimepiride

Arm Description

Nateglinide 90~120mg three times a day

Glimepiride 1~2mg once a day

Outcomes

Primary Outcome Measures

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%)

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2009
Last Updated
May 15, 2017
Sponsor
Ajou University School of Medicine
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
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1. Study Identification

Unique Protocol Identification Number
NCT00858013
Brief Title
Study of the Durability of Glycemic Control With Nateglinide
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 24, 2009 (Actual)
Primary Completion Date
June 25, 2014 (Actual)
Study Completion Date
June 25, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Nateglinide, Pancreatic beta cell function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nateglinide
Arm Type
Active Comparator
Arm Description
Nateglinide 90~120mg three times a day
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
Glimepiride 1~2mg once a day
Intervention Type
Drug
Intervention Name(s)
Nateglinide
Other Intervention Name(s)
fastic
Intervention Description
Nateglinide 90~120mg three times a day
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Other Intervention Name(s)
amaryl
Intervention Description
Glimepiride 1~2mg once a day
Primary Outcome Measure Information:
Title
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate
Description
% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)
Time Frame
every 3 months following randomization, for 24 months
Secondary Outcome Measure Information:
Title
HbA1c
Description
HbA1c (%) at 24 months
Time Frame
at 24 months
Title
Fasting Glucose
Description
fasting glucose (mg/dL) at 24 months
Time Frame
at 24 months
Title
C-peptide
Description
c-peptide(uU/mL) at 24 months
Time Frame
at 24 months
Title
HOMA-IR
Description
insulin resistance marker HOMA-IR at 24 months
Time Frame
at 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwan Woo Lee, MD,PhD
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Myongji Hospital
City
Ilsan
State/Province
Kyounggi
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Guri-si
State/Province
Kyunggi-do
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung hee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon-si
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of the Durability of Glycemic Control With Nateglinide

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