Clinical trial NCT00858013: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Nateglinide
Pancreatic beta cell function
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Korea University Guro Hospital
name: Hanyang University
name: Inha University Hospital
name: Kyunghee University Medical Center
name: Myongji Hospital
name: Bundang CHA Hospital
name: Wonju Severance Christian Hospital
name: Hallym University Medical Center
First posted: 2009-03-09
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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

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

Primary outcomes:
measure: The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate
timeFrame: every 3 months following randomization, for 24 months
Secondary outcomes:
measure: HbA1c
timeFrame: at 24 months
measure: Fasting Glucose
timeFrame: at 24 months
measure: C-peptide
timeFrame: at 24 months
measure: HOMA-IR
timeFrame: at 24 months
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Myongji Hospital
state: Kyounggi
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Kyunggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung hee University Medical Center
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: Kwan Woo Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: