Study of the Durability of Glycemic Control With Nateglinide

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858013
• Other study ID #: AJIRB-CRO-08-197
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2009
• Last updated: May 15, 2017
• Start date: April 24, 2009
• Est. completion date: June 25, 2014

Study information

• Verified date: May 2017
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 25, 2014
• Est. primary completion date: June 25, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Nateglinide
Nateglinide 90~120mg three times a day
• Glimepiride
Glimepiride 1~2mg once a day

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Medical Center	Guri-si	Kyunggi-do
Korea, Republic of	Myongji Hospital	Ilsan	Kyounggi
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

Sponsors (9)

Lead Sponsor	Collaborator
Ajou University School of Medicine	Bundang CHA Hospital, Hallym University Medical Center, Hanyang University, Inha University Hospital, Korea University Guro Hospital, Kyunghee University Medical Center, Myongji Hospital, Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c	HbA1c (%) at 24 months	at 24 months
Secondary	Fasting Glucose	fasting glucose (mg/dL) at 24 months	at 24 months
Secondary	C-peptide	c-peptide(uU/mL) at 24 months	at 24 months
Secondary	HOMA-IR	insulin resistance marker HOMA-IR at 24 months	at 24 months