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

Completed · Phase 4

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00402909

Run by

Novartis Pharmaceuticals

People needed

28

Starts

2006-11-01

Expected to finish

2007-08-01

Last updated by the study team

2017-02-24

Who can join

Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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