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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

NCT01676220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 878

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 in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus

Secondary Objectives:

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

\- occurrence of nocturnal hypoglycemia

Conditions

Interventions

DRUG

HOE901-U300 (new formulation of insulin glargine)

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]).

DRUG

Lantus (insulin glargine)

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

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
2012-08-31
Primary Completion
2013-09-30
Completion
2014-03-31

Countries

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

Study Locations

More Related Trials

Entities

Diseases
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 NCT01676220 on ClinicalTrials.gov