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

NCT01053728 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2011-07-26

No results posted yet for this study

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

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

SAR161271

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

DRUG

Insulin glargine HOE901

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-05-31
Completion
2010-11-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053728 on ClinicalTrials.gov