Trials / Completed
CompletedNCT00858013
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Ajou University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nateglinide | Nateglinide 90\~120mg three times a day |
| DRUG | Glimepiride | Glimepiride 1\~2mg once a day |
Timeline
- Start date
- 2009-04-24
- Primary completion
- 2014-06-25
- Completion
- 2014-06-25
- First posted
- 2009-03-09
- Last updated
- 2017-05-16
- Results posted
- 2017-03-31
Locations
7 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00858013. Inclusion in this directory is not an endorsement.