Lantus in Prediabetes
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperglycemia; Diabetes Mellitus
Intervention: Lantus® (insulin glargine) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Peter JOHNSTON, MD, Study Director, Affiliation: Sanofi
Summary
To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in
prediabetes (IFG or IGT).
Clinical Details
Official title: Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Efficacy: 8-point blood glucose measurements.Safety / tolerability: hypoglycemia
Secondary outcome: Blood glucose in response to exercise.Fasting supine levels of counterregulatory hormones
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Sanofi-Aventis, Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: February 2002
Last updated: July 4, 2006
|