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Lantus in Prediabetes
This study has been completed.

First Received on July 4, 2006.   No Changes Posted
Sponsor: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00348972
  Purpose

To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).


Condition Intervention Phase
Hyperglycemia
Diabetes Mellitus
 Drug: Lantus® (insulin glargine)
 Phase I

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Diabetes Medicines Pre-diabetes
Drug Information available for: Insulin Insulin beef Dextrose Insulin glargine
U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Efficacy: 8-point blood glucose measurements.
  • Safety / tolerability: hypoglycemia

Secondary Outcome Measures:
  • Blood glucose in response to exercise.
  • Fasting supine levels of counterregulatory hormones

Estimated Enrollment: 20
Study Start Date: February 2002
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
  • HbA1c < 7.0%
  • BMI < 40kg/m2
  • Able to perform moderate stationary bicycle exercise

Exclusion Criteria:

  • Chronic pharmacologic treatment for hyperglycemia, past or present
  • CAD
  • serum creatinine > 2.0mg/dL
  • BP > 180/105
  • History of hypoglycemia unawareness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348972

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Peter JOHNSTON, MD Sanofi-Aventis
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00348972     History of Changes
Other Study ID Numbers: HOE901/1021, HOE901
Study First Received: July 4, 2006
Last Updated: July 4, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Glargine
prediabetes
impaired glucose tolerance
impaired fasting glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012



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