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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00402909

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Nateglinide	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Change from baseline in hemoglobin (Hb)_A1c []

Secondary Outcome Measures

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% []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

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