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

Phase 4

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00402909
• Lead Sponsor: Novartis Pharmaceuticals

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 type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-20
• Study First Posted: 2006-11-22
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin (Hb)_A1c

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%
Change from baseline in 2-hour postprandial glucose during standardized meal test
Proportion of patients achieving reduction in HbA1c of 0.5%

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States