Lantus in Prediabetes

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine

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