NCT00712673|CompletedPhase 3ResultsDMC

GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

GETGOAL-M

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 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

EFC6014EudraCT 2007-005880-80

Study Type

interventional

Target

680

Locations

16 countries

Sites

Timeline

RegisteredJul 2008

StartedJun 2008

CompletionMar 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 metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide as an add-on treatment to metformin in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effect of lixisenatide, in comparison to placebo, when administered in the evening within 1 hour prior to the meal in terms of HbA1c reduction, 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), plasma glucose, plasma insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test (only in morning injection arms), body weight, beta-cell function assessed by homeostasis model assessment (HOMA)-beta, fasting plasma insulin (FPI) and adiponectin; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development, beta-cell function 4 weeks after study drug discontinuation (only in patients from the morning injection arms in some selected centers).

Trial Health

On Track

Trial Health Score

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

Enrollment

680

participants targeted

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

Timeline

Completed

Started Jun 2008

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

Geographic Reach

16 countries

16 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

2.7 years study duration

Study Start

First participant enrolled

June 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed

5.8 years until next milestone

Results Posted

Study results publicly available

December 15, 2016

Completed

Last Updated

December 15, 2016

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

July 7, 2008

Results QC Date

August 18, 2016

Last Update Submit

October 24, 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 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 Modified Intent-to-treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Baseline, Week 24

Secondary Outcomes (16)

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline, Week 24
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24
Baseline, Week 24
Change From Baseline in Body Weight at Week 24
Baseline, Week 24
Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24
Baseline, Week 24
Change From Baseline in 2-Hour Postprandial Plasma Insulin (PPI) at Week 24
Baseline, Week 24
+11 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

Study Arms (4)

Lixisenatide (Morning Injection)

EXPERIMENTAL

2-step initiation morning 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 end of treatment.

Drug: Lixisenatide (AVE0010)Device: Pen auto-injectorDrug: Metformin

Lixisenatide (Evening Injection)

EXPERIMENTAL

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

Drug: Lixisenatide (AVE0010)Device: Pen auto-injectorDrug: Metformin

Placebo (Morning Injection)

PLACEBO COMPARATOR

2-step initiation morning 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 end of treatment.

Drug: PlaceboDevice: Pen auto-injectorDrug: Metformin

Placebo (Evening Injection)

PLACEBO COMPARATOR

2-step initiation evening 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 end of treatment.

Drug: PlaceboDevice: Pen auto-injectorDrug: Metformin

Interventions

Lixisenatide (AVE0010)DRUG

Self administered by subcutaneous injections once daily within the hour preceding meal (either breakfast or dinner).

Lixisenatide (Evening Injection)Lixisenatide (Morning Injection)

PlaceboDRUG

Self administered by subcutaneous injections once daily within the hour preceding meal (either breakfast or dinner).

Placebo (Evening Injection)Placebo (Morning Injection)

Pen auto-injectorDEVICE

Also known as: OptiClik®

Lixisenatide (Evening Injection)Lixisenatide (Morning Injection)Placebo (Evening Injection)Placebo (Morning Injection)

MetforminDRUG

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

Lixisenatide (Evening Injection)Lixisenatide (Morning Injection)Placebo (Evening Injection)Placebo (Morning Injection)

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/ day (g/day) for at least 3 months prior to screening visit

You may not qualify if:

HbA1c \<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 an antidiabetic pharmacological agent other 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) \<=20 kilogram per square meter (kg/m\^2)
Weight change of \>5 kg during the 3 months preceding the study screening visit
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 supine 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.