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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00402909
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Nateglinide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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)
Study Start Date : November 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Nateglinide

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00402909

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United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07974
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00402909    
Other Study ID Numbers: CDJN608AUS13
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 diabetes,
fasting glucose,
postprandial glucose,
blood sugar,
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs