NCT00707031|CompletedPhase 3ResultsDMC

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

GETGOAL-X

A Randomized, Open-label, Active-controlled, 2-arm Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 Versus Exenatide on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC60192007-005883-28

Study Type

interventional

Target

639

Locations

18 countries

Sites

Timeline

RegisteredJun 2008

StartedJun 2008

CompletionNov 2010

Brief Summary

The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide in comparison to exenatide (Byetta®), as an add-on treatment to 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 (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life \[PAGI-QOL\]).

Trial Health

On Track

Trial Health Score

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

Enrollment

639

participants targeted

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

Timeline

Completed

Started Jun 2008

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach

18 countries

18 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

2.4 years study duration

Study Start

First participant enrolled

June 1, 2008

Completed

25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2008

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed

5.9 years until next milestone

Results Posted

Study results publicly available

October 11, 2016

Completed

Last Updated

December 2, 2016

Status Verified

October 1, 2016

Enrollment Period

2.4 years

First QC Date

June 26, 2008

Results QC Date

August 18, 2016

Last Update Submit

October 20, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

hyperglycemia, GLP-1, metformin

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 11 (Week 24) or Day 169 if Visit 11 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 (5)

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
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24
Week 24
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24
Week 24
Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period
Baseline up to Week 24

Other Outcomes (3)

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 116 weeks
Quality of Life: Change From Baseline in Patient's Satisfaction to Treatment (PAGI-QOL) at Week 24
Baseline, Week 24

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)Device: Pen auto-injectorDrug: Metformin

Exenatide

ACTIVE COMPARATOR

1-step initiation regimen of exenatide: 5 mcg twice daily (BID) for 4 weeks, followed by 10 mcg BID up to the end of treatment.

Drug: ExenatideDevice: Prefilled pen injectorDrug: Metformin

Interventions

Lixisenatide (AVE0010)DRUG

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

Lixisenatide

Pen auto-injectorDEVICE

Also known as: OptiClik®

Lixisenatide

ExenatideDRUG

Self administered by subcutaneous injections twice daily within the hour preceding breakfast and within the hour preceding dinner.

Also known as: Byetta®

Exenatide

Prefilled pen injectorDEVICE

Exenatide

MetforminDRUG

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

ExenatideLixisenatide

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 metformin at a stable dose of at least 1.5 gram per day for at least 3 months prior to screening visit

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 another antidiabetic pharmacological agent than metformin within the 3 months preceding the screening
FPG at screening \>250 milligram per deciliter (mg/dL) (13.9 millimole per liter \[mmol/L\])
Body mass index (BMI) less than or equal to (\<=) 20 kilogram per square meter (kg/m\^2)
Weight change of \>5 kg during the 3 months preceding the study
History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, 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
Known history of drug or alcohol abuse within 6 months prior to the time of screening
Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure or diastolic blood pressure \>180 millimeter of mercury (mmHg) or \>95 mmHg, respectively
+10 more criteria

Contact the study team to confirm eligibility.