Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
(EAGLE Trial)

Recruiting in Palo Alto (17 mi)

+135 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Sanofi

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Inclusion Criteria

Patients With Type 2 Diabetes diagnosed for at least 1 year

Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DiPeptidyl Peptidase IV inhibitor), for more than 3 months

7.5% < HbA1c <= 12%

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Treatment Details

Interventions

Insulin Glargine (Insulin)
Liraglutide (GLP-1 Receptor Agonist)
Metformin (Biguanide)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Insulin GlargineExperimental Treatment2 Interventions

Insulin glargine administered once a day, in the morning or in the evening, at the most convenient time. The time of injection, once chosen was to remain unchanged during the whole duration of the study. The starting dose was 0.2 Unit per kilogram of body weight or 10 Units. Patients were empowered to adjust their insulin doses, under strict investigator's supervision. Insulin titration (by 2 or 4 Units) was done every 3 days according to the median value of Fasting Plasma Glucose (FPG) of the last 3 days. The goal was to achieve 70 \< FPG ≤ 100 mg/dL (3.9 \< FPG ≤ 5.5 mmol/L). Minor deviations from the titration scheme could be allowed, based on Investigator's judgment and patient's situation.

Group II: LiraglutideActive Control2 Interventions

Liraglutide administered once a day, in the morning or in the evening, at the most convenient time. The time of injection , once chosen was to remain unchanged during the whole duration of the study. The dose was 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24. The dose might be decreased to 1.2 mg for safety reasons (e.g. gastro-intestinal tolerability), based on Investigator's judgment.

Insulin Glargine is already approved in Canada, Japan, China, Switzerland for the following indications: