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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

NCT01683266 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2015-06-24

Study results available
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Summary

Primary Objective:

* To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
* Change of HbA1c from baseline to endpoint (scheduled Month 6)
* Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
* Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
* Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
* Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

HOE901-U300 (Insulin glargine new formulation)

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-09-30
Completion
2014-03-31

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Hungary
  • Japan
  • Latvia
  • Netherlands
  • Puerto Rico
  • Romania
  • Sweden

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 NCT01683266 on ClinicalTrials.gov