Lantus in Prediabetes
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperglycemia; Diabetes Mellitus
Intervention: Lantus┬« (insulin glargine) (Drug)
Phase: Phase 1
Sponsored by: Sanofi-Aventis
Official(s) and/or principal investigator(s):
Peter JOHNSTON, MD, Study Director, Affiliation: Sanofi-Aventis
To assess the safety, tolerability, and efficacy of Lantus« (insulin glargine) in prediabetes
(IFG or IGT).
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Efficacy: 8-point blood glucose measurements.
Safety / tolerability: hypoglycemia
Blood glucose in response to exercise.
Fasting supine levels of counterregulatory hormones
Minimum age: 18 Years.
Maximum age: 70 Years.
- Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
- HbA1c < 7. 0%
- BMI < 40kg/m2
- Able to perform moderate stationary bicycle exercise
- Chronic pharmacologic treatment for hyperglycemia, past or present
- serum creatinine > 2. 0mg/dL
- BP > 180/105
- History of hypoglycemia unawareness
Locations and Contacts
Sanofi-Aventis, Bridgewater, New Jersey 08807, United States
Starting date: February 2002
Last updated: July 4, 2006