NCT00715624|CompletedPhase 3ResultsDMC

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin

GETGOAL-L

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC60162007-005886-36

Study Type

interventional

Target

496

Locations

15 countries

Sites

Timeline

RegisteredJul 2008

StartedJul 2008

CompletionFeb 2011

Brief 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 basal insulin with or without 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 basal insulin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24. The secondary objectives are to assess the effects of lixisenatide when added to basal insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

496

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started Jul 2008

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach

15 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

July 1, 2008

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2008

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed

5.7 years until next milestone

Results Posted

Study results publicly available

October 11, 2016

Completed

Last Updated

November 28, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

July 11, 2008

Results QC Date

August 18, 2016

Last Update Submit

October 14, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

hyperglycemia, GLP-1, metformin, insulin

Outcome Measures

Primary Outcomes (1)

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Baseline, Week 24

Secondary Outcomes (8)

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
Baseline, Week 24
Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24
Baseline, Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline, Week 24
Change From Baseline in Body Weight at Week 24
Baseline, Week 24
Change From Baseline in Total Insulin Dose at Week 24
Baseline, Week 24
+3 more secondary outcomes

Other Outcomes (3)

Change From Baseline in Glucose Excursion at Week 24
Baseline, Week 24
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24
Baseline, Week 24
Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia
First dose of study drug up to 3 days after the last dose administration for up to 125 weeks

Study Arms (2)

Lixisenatide

EXPERIMENTAL

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.

Drug: Lixisenatide (AVE0010)Drug: Basal InsulinDrug: MetforminDevice: Pen auto-injector

Placebo

PLACEBO COMPARATOR

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.

Drug: PlaceboDrug: Basal InsulinDrug: MetforminDevice: Pen auto-injector

Interventions

Lixisenatide (AVE0010)DRUG

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Lixisenatide

PlaceboDRUG

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Placebo

Basal InsulinDRUG

Dose to be kept stable.

LixisenatidePlacebo

MetforminDRUG

Metformin if given to be continued at stable dose (1.5 gram per day) up to the end of treatment.

LixisenatidePlacebo

Pen auto-injectorDEVICE

Also known as: OptiClik®

LixisenatidePlacebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with basal insulin with or without metformin

You may not qualify if:

HbA1c less than (\<) 7 % or greater than (\>) 10% at screening
At the time of screening age \< legal age of majority
Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
Type 1 diabetes mellitus
Treatment with basal insulin for less than 3 months prior to screening or insulin regimen changed during the last 3 months prior to screening
Basal insulin dose at screening \<30 units/day and/or not at a stable dose (+/- 20 percent \[%\]) during the last 2 months
If treatment with metformin, no stable dose of at least 1.5 gram/day (except for South Korea: at least 1.0 gram/day) for at least 3 months prior to screening visit
FPG at screening \>250 milligram per deciliter (mg/dL) (\>13.9 millimole per liter \[mmol/L\])
History of hypoglycemia unawareness
Body mass index less than or equal to (\<=) 20 kilogram per square meter (kg/m\^2)
Weight change of \>5 kg during the 3 months preceding the screening visit
History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease
History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening
Within the last 6 months prior to screening, history of myocardial infarction, stroke, or heart failure requiring hospitalization
+14 more criteria

Contact the study team to confirm eligibility.