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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 2,4-thiazolidinedione; Insulin; Insulin Glargine; Metformin; Nateglinide; Pioglitazone; Rosiglitazone

Criteria

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.