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Lantus in Prediabetes
This study has been completed.
First Received: 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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin 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

Study ID Numbers: HOE901/1021, HOE901
Study First Received: July 4, 2006
Last Updated: July 4, 2006
ClinicalTrials.gov Identifier: NCT00348972     History of Changes
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:
Hypoglycemic Agents
Metabolic Diseases
Hyperglycemia
Physiological Effects of Drugs
Glucose Intolerance
Glargine
 Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 27, 2009



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