Study of the Durability of Glycemic Control With Nateglinide - Full Text View

Sponsor:	Ajou University School of Medicine
Collaborators:	Korea University Guro Hospital Hanyang University Inha University Hospital Kyunghee University Medical Center
Information provided by:	Ajou University School of Medicine
ClinicalTrials.gov Identifier:	NCT00858013

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride A 4166

U.S. FDA Resources

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 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nateglinide: Active Comparator Nateglinide 90~120mg three times a day	Drug: Nateglinide Nateglinide 90~120mg three times a day
Glimepiride: Active Comparator Glimepiride 1~2mg once a day	Drug: Glimepiride Glimepiride 1~2mg once a day

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

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
Ajou University Hospital
Suwon, Korea, Republic of
Kyung hee University Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Inha University Hospital
In Cheon, Korea, Republic of
Korea, Republic of, Kyunggi-do
Hanyang University Medical Center
Kuri, Kyunggi-do, Korea, Republic of

Sponsors and Collaborators

Ajou University School of Medicine

Korea University Guro Hospital

Hanyang University

Inha University Hospital

Kyunghee University Medical Center

Investigators

Principal Investigator:

Kwan Woo Lee, MD,PhD

Ajou University Hospital

More Information

No publications provided

Responsible Party:	Ajou University ( Kwan Woo Lee/ Chief of the Department of Endocrinology and Metabolism )
Study ID Numbers:	AJIRB-CRO-08-197
Study First Received:	March 6, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00858013 History of Changes
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:

Metabolic Diseases
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Nateglinide
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010