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Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

NCT01117350 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 978

Last updated 2014-04-11

Study results available
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Summary

Primary objective:

To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) \< 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents

Secondary objectives of the comparative period (24 weeks):

\>To assess the effect of insulin glargine in comparison with liraglutide on:

* HbA1c level
* Percentage of patients whose HbA1c has decreased but remains \>= 7% at the end of the comparative period
* Percentage of patients whose HbA1c has increased at the end of the comparative period
* Fasting Plasma Glucose (FPG)
* 7-point Plasma Glucose (PG) profiles
* Hypoglycemia occurrence
* Body weight
* Adverse events

Objectives of the extension period (24 weeks):

\>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:

* HbA1c level
* FPG
* 7-point PG profiles
* Hypoglycemia occurrence
* Body weight
* Adverse events

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glargine

100 Units/mL solution for injection in a pre-filled SoloStar pen

DRUG

Liraglutide

6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg)

DRUG

Metformin

Metformin was a background treatment, mandatory for each patient randomized in the study (at the minimum dose of 1g/day). It was not supplied by the sponsor.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-10-31
Completion
2013-03-31

Countries

  • United States
  • Austria
  • Brazil
  • Canada
  • Czechia
  • Finland
  • France
  • Greece
  • Ireland
  • Israel
  • Mexico
  • Netherlands
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

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Entities

Drugs
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 NCT01117350 on ClinicalTrials.gov