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

NCT01689129 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2014-06-09

No results posted yet for this study

Summary

Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 \[week 26\]) in japanese patients with type 1 diabetes mellitus

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.

To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin glargine new formulation (HOE901)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Insulin glargine (HOE901) (Lantus)

Pharmaceutical form: solution Route of administration: subcutaneous

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
2013-10-31
Completion
2014-04-30

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 NCT01689129 on ClinicalTrials.gov