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

February 22, 2017 updated by: Novartis Pharmaceuticals

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07974
        • Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in hemoglobin (Hb)_A1c

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 20, 2006

First Posted (Estimate)

November 22, 2006

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDJN608AUS13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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