NCT01195454CompletedPhase 1
Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)
Study Overview
Brief Summary
Primary Objective:
- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus®
Secondary Objectives:
- To assess the exposure ratios of a new insulin glargine formulation versus Lantus®
- To compare the duration of action of a new insulin glargine formulation versus Lantus®
- To explore the dose response and dose exposure relationship of a new insulin glargine formulation
- To assess the safety and tolerability of a new insulin glargine formulation
Detailed Description
The study period for one patient is one month in average and it can last up to 11 weeks broken down as follows:
- Screening: 3 to 28 days
- Treatment period: 1 to 4 days: 2 days (1 overnight stay)
- Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings)
- End of study: 1 day after the last dosing
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Insulin glargine / New insulin glargine formulation
Experimental
- Period 1: Insulin glargine
- Period 2: New insulin glargine formulation
- Period 3: New insulin glargine formulation
- Period 4: New insulin glargine formulation
Duration of treatment: 1 day at each period
Intervention: Insulin glargine (HOE901) (Drug)
Outcomes
Primary Outcomes
The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)
Time Frame: 36 hours (D1 to D2) in all four treatment periods
Secondary Outcomes
- The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -(36 hours (D1 to D2) in all four treatment periods)
- Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36)(36 hours (D1 to D2) in all four treatment periods)
- Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36)(36 hours (D1 to D2) in all four treatment periods)
- Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)(36 hours (D1 to D2) in all four treatment periods)
- Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax)(36 hours (D1 to D2) in all four treatment periods)
- Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax)(36 hours (D1 to D2) in all four treatment periods)
Investigators
Study Sites (1)
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