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Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

NCT01349855 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-06-01

No results posted yet for this study

Summary

Primary Objective:

To assess the safety and tolerability of two dose levels of a new insulin glargine formulation in a once-daily multiple dosing regimen

Secondary Objective:

To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new insulin glargine formulation with 0.4 U/kg Lantus® in a once-daily multiple dosing regimen

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin glargine HOE901

Pharmaceutical form:solution for injection: new formulation and marketed formulation 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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-05-31
Completion
2011-05-31

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 NCT01349855 on ClinicalTrials.gov