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

Type 2 Diabetes Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402909
• Other study ID #: CDJN608AUS13
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2006
• Last updated: February 22, 2017
• Start date: November 2006
• Est. completion date: August 2007

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Nateglinide

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin (Hb)_A1c
Secondary	Change from baseline in 2-hour postprandial glucose during standardized meal test
Secondary	Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%
Secondary	Proportion of patients achieving reduction in HbA1c of 0.5%

External Links

•   American Diabetes Association 68th Scientific Sessions (2008)
•   Results for CDJN608AUS13 from the Novartis Clinical Trials website