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GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea (GETGOAL-S Trial)

Phase 3

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with a sulfonylurea alone or a sulfonylurea in association with metformin

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose of study drug up to 3 days after the last dose administration, for up to 120 weeks

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Approved for 20 Other Conditions

Summary

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (\<) 7 percent (%); percentage of patients reaching HbA1c less than or equal to (\<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Eligible Conditions

Diabetes
Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose of study drug up to 3 days after the last dose administration, for up to 120 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose of study drug up to 3 days after the last dose administration, for up to 120 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose of study drug up to 3 days after the last dose administration, for up to 120 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Secondary study objectives

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24

Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24

Change From Baseline in Body Weight at Week 24

+8 more

Other study objectives

Insulin

Change From Baseline in Glucose Excursion at Week 24

Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LixisenatideExperimental Treatment4 Interventions

2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.

Group II: PlaceboPlacebo Group4 Interventions

2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

FDA approved

Sulfonylurea

2017

Completed Phase 4

~554130

Lixisenatide

FDA approved