Study of the Durability of Glycemic Control With Nateglinide

NCT00858013 | Completed Phase 4 Results DMC

• 1 other identifier: AJIRB-CRO-08-197
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 7

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Nateglinide; Pancreatic beta cell function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• HbA1c

  at 24 months

• Fasting Glucose

  at 24 months

• C-peptide

  at 24 months

• HOMA-IR

  at 24 months

Study Arms (2)

Nateglinide

ACTIVE COMPARATOR

Nateglinide 90\~120mg three times a day

Drug: Nateglinide

Glimepiride

ACTIVE COMPARATOR

Glimepiride 1\~2mg once a day

Drug: Glimepiride

Interventions

Nateglinide DRUG

Nateglinide 90\~120mg three times a day

Also known as: fastic

Nateglinide

Glimepiride DRUG

Glimepiride 1\~2mg once a day

Also known as: amaryl

Glimepiride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• % ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• Korea University Guro Hospital: collaborator
• Hanyang University: collaborator
• Inha University Hospital: collaborator
• Kyunghee University Medical Center: collaborator
• Myongji Hospital: collaborator
• Bundang CHA Hospital: collaborator
• Wonju Severance Christian Hospital: collaborator
• Hallym University Medical Center: collaborator

Study Sites (7)

Hanyang University Medical Center

Guri-si, Gyeonggi-do, South Korea

Location

Myongji Hospital

Ilsan, Kyounggi, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Hallym University Medical Center

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung hee University Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nateglinide; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kwan Woo Lee
• Organization: Ajou University

lkw65@ajou.ac.kr

82-31-219-4526

Study Officials

• Kwan Woo Lee, MD,PhD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: April 24, 2009
• Primary Completion: June 25, 2014
• Study Completion: June 25, 2014
• Last Updated: May 16, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)