Status:
COMPLETED
Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-78 years
Phase:
PHASE4
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 typ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00402909
Start Date
November 1 2006
End Date
August 1 2007
Last Update
February 24 2017
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07974