Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone

A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Compare the Safety and Efficacy of Nateglinide vs. Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Basal Insulin Glargine in Combination With Metformin and/or Thiazolidinedione (Pioglitazone or Rosiglitazone)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402909

Enrollment

Registered

2006-11-22

Start date

2006-11-30

Completion date

2007-08-31

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes,, fasting glucose,, postprandial glucose,, blood sugar,, HbA1c,, insulin,, glargine,, metformin,, thiazolidinedione

Brief summary

This study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.

Interventions

DRUGNateglinide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

Inclusion criteria

* Male/female, age 18-78 inclusive * Type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening * HbA1c 7.0-8.5% inclusive * Fasting plasma glucose \<240 mg/dL at screening * Body Mass Index 22-41 kg/m2

Exclusion criteria

* Pregnant or nursing * Other investigational drugs within 30 days of screening * Treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione * History of type 1 diabetes * Abnormal kidney function * History of acute diabetic complications * Congestive heart failure requiring treatment * Myocardial infarction, coronary artery surgery, stroke within 6 months of screening * Liver disease, liver enzymes more than 3 times upper limit of normal * Fasting triglycerides \>700 mg/dL within past 12 weeks * Acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data * Treatment with corticosteroids * Blood donation within past 12 weeks Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline in hemoglobin (Hb)_A1c	—

Secondary

Measure	Time frame
Change from baseline in 2-hour postprandial glucose during standardized meal test	—
Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%	—
Proportion of patients achieving reduction in HbA1c of 0.5%	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026