Lantus in Prediabetes

Sanofi

Status and phase: Completed; Phase 1

Conditions: Hyperglycemia; Diabetes Mellitus

Treatments: Drug: Lantus® (insulin glargine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348972

HOE901/1021

HOE901

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind