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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Nateglinide


Participation Criteria
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Eligibility Criteria
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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/exclusion criterial may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nateglinide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hemoglobin (Hb)_A1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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% |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes,, fasting glucose,, postprandial glucose,, blood sugar,, HbA1c,, insulin,, glargine,, metformin,, thiazolidinedione