Status:
COMPLETED
Lantus in Prediabetes
Lead Sponsor:
Sanofi
Conditions:
Hyperglycemia
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).
Eligibility Criteria
Inclusion
- Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
- HbA1c \< 7.0%
- BMI \< 40kg/m2
- Able to perform moderate stationary bicycle exercise
Exclusion
- Chronic pharmacologic treatment for hyperglycemia, past or present
- CAD
- serum creatinine \> 2.0mg/dL
- BP \> 180/105
- History of hypoglycemia unawareness
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00348972
Start Date
February 1 2002
Last Update
July 6 2006
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807