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P021

Peptide 021, GLXC-21260

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Studies 37
Trials 57
Completed PHASE4 INTERVENTIONAL NCT01117350

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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

Detailed Description

Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) broken down as follow: * A 2-week of screening period, * A 24-week comparative period, * A 24-week extension period (only for patients treated with liraglutide, not adequately controlled at the end of the comparative period), * A 1-week follow-up period

Interventions

Name: Insulin glargine
Type: DRUG
Description: 100 Units/mL solution for injection in a pre-filled SoloStar pen
Name: Liraglutide
Type: DRUG
Description: 6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg)
Name: Metformin
Type: DRUG
Description: 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.

Primary Outcomes

Measure: Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period
TimeFrame: week 12, week 24
Description: The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward \[LOCF\] value).

Trial Information

NCT ID

NCT01117350

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Sanofi

Last Updated

December 15, 2025