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Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®

NCT01195454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-10-31

No results posted yet for this study

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

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin glargine (HOE901)

Pharmaceutical form: Lantus solution for injection Route of administration: subcutaneous

DRUG

Insulin glargine (HOE901)

Pharmaceutical form: New insulin glargine formulation 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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT01195454 on ClinicalTrials.gov