drugset
drugset / Trial / NCT01053728

Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)

NCT01053728 ↗

Phase 1/2 Completed 46 enrolled Sanofi
RandomizedCrossoverDouble-blindTreatment

Summary

Primary Objective: \- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM. Secondary Objective: \- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM

Timeline

Start
2010-02
Primary completion
2010-05
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject SAR161271 Unknown 0.3 iu/kg Subcutaneous
Subject SAR161271 Unknown 0.6 iu/kg Subcutaneous
Subject SAR161271 Unknown 1.2 iu/kg Subcutaneous
Subject insulin glargine Protein / enzyme biologic 0.3 iu/kg Subcutaneous
Subject insulin glargine Protein / enzyme biologic 0.6 iu/kg Subcutaneous
Subject insulin glargine Protein / enzyme biologic 1.2 iu/kg Subcutaneous

Indications

type 1 diabetes mellitus