Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone
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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.
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
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 78 Years (Adult, Senior)
Sexes Eligible for Study:
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
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.