Title

Study of the Durability of Glycemic Control With Nateglinide
Multi-center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    88
This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.
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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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.
Study Started
Apr 24
2009
Primary Completion
Jun 25
2014
Study Completion
Jun 25
2014
Results Posted
Mar 31
2017
Last Update
May 16
2017

Drug Nateglinide

Nateglinide 90~120mg three times a day

  • Other names: fastic

Drug Glimepiride

Glimepiride 1~2mg once a day

  • Other names: amaryl

Nateglinide Active Comparator

Nateglinide 90~120mg three times a day

Glimepiride Active Comparator

Glimepiride 1~2mg once a day

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

Summary

Nateglinide

Glimepiride

All Events

Event Type Organ System Event Term Nateglinide Glimepiride

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%)

Nateglinide

Glimepiride

HbA1c

HbA1c (%) at 24 months

Nateglinide

6.9
% HbA1c (Mean)
Standard Deviation: 0.6

Glimepiride

6.5
% HbA1c (Mean)
Standard Deviation: 0.5

Fasting Glucose

fasting glucose (mg/dL) at 24 months

Nateglinide

131.2
mg/dL (Mean)
Standard Deviation: 25.9

Glimepiride

115.7
mg/dL (Mean)
Standard Deviation: 19.8

C-peptide

c-peptide(uU/mL) at 24 months

Nateglinide

1.29
uU/mL (Mean)
Standard Deviation: 0.41

Glimepiride

1.77
uU/mL (Mean)
Standard Deviation: 0.72

HOMA-IR

insulin resistance marker HOMA-IR at 24 months

Nateglinide

2.4
mg/dL x mIU/L (Mean)
Standard Deviation: 1.36

Glimepiride

2.31
mg/dL x mIU/L (Mean)
Standard Deviation: 1.70

Total

88
Participants

Age, Continuous

55
years (Mean)
Standard Deviation: 11

Sex: Female, Male

Overall Study

Nateglinide

Glimepiride