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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00402909
First received: November 20, 2006
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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)
  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402909

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00402909     History of Changes
Other Study ID Numbers: CDJN608AUS13
Study First Received: November 20, 2006
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes,
fasting glucose,
postprandial glucose,
blood sugar,
HbA1c,
insulin,
glargine,
metformin,
thiazolidinedione

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
2,4-thiazolidinedione
Glargine
Insulin
Metformin
Nateglinide
Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014