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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: November 20, 2006
Last updated: February 22, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Type 2 Diabetes Drug: Nateglinide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change from baseline in hemoglobin (Hb)_A1c

Secondary Outcome Measures:
  • 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%

Enrollment: 28
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00402909

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07974
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00402909     History of Changes
Other Study ID Numbers: CDJN608AUS13
Study First Received: November 20, 2006
Last Updated: February 22, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 diabetes,
fasting glucose,
postprandial glucose,
blood sugar,

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 20, 2017