Phase 4
Completed N=88
Study of the Durability of Glycemic Control With Nateglinide
Source: ClinicalTrials.gov NCT00858013 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate — 10; 7 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate |
10; 7 | — |
| SECONDARY HbA1c |
6.9; 6.5 | — |
| SECONDARY Fasting Glucose |
131.2; 115.7 | — |
| SECONDARY C-peptide |
1.29; 1.77 | — |
| SECONDARY HOMA-IR |
2.40; 2.31 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00858013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.