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Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

NCT01493115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-05-01

No results posted yet for this study

Summary

Primary Objective:

To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus®

Secondary Objective:

To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin glargine HOE901

Pharmaceutical form:solution for injection Route of administration: subcutaneous

DRUG

Insulin glargine - New formulation 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
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Japan

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 NCT01493115 on ClinicalTrials.gov