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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

NCT01658579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2015-06-01

Study results available
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Summary

Primary Objective:

* To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus

Secondary Objectives:

* To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
* To compare the incidence and frequency of hypoglycemic episodes
* To assess the safety and tolerability of the new formulation of insulin glargine

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

HOE901-U300 (new formulation of insulin glargine)

DRUG

Lantus (insulin glargine)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

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 NCT01658579 on ClinicalTrials.gov