NCT00688701|CompletedPhase 3ResultsDMC

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

GETGOAL-MONO

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter 12-week Study Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Not Treated With Antidiabetic Agents

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC6018EudraCT 2007-005887-29

Study Type

interventional

Target

361

Locations

12 countries

Sites

Timeline

RegisteredJun 2008

StartedMay 2008

CompletionDec 2009

Brief Summary

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, used in a 2-step dose titration regimen in monotherapy, over a period of 12 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to placebo, on glycemic control using a 2-step dose titration regimen in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 12. Secondary objectives are to assess the effects of lixisenatide, in comparison to placebo, on glycemic control in terms of HbA1c reduction when it is used in a one-step dose titration regimen over a period of 12 weeks, body weight, fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (PPG) after a standardized meal, to assess the safety and 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

361

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started May 2008

Geographic Reach

12 countries

12 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

1.6 years study duration

Study Start

First participant enrolled

May 1, 2008

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed

27 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed

7 years until next milestone

Results Posted

Study results publicly available

December 12, 2016

Completed

Last Updated

December 12, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

May 7, 2008

Results QC Date

August 16, 2016

Last Update Submit

October 18, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

hyperglycemia, GLP-1

Outcome Measures

Primary Outcomes (1)

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. 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 12

Secondary Outcomes (6)

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12
Baseline, Week 12
Change From Baseline in Body Weight at Week 12
Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Baseline, Week 12
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12
Week 12
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12
Week 12
+1 more secondary outcomes

Other Outcomes (3)

Change From Baseline in Glucose Excursion at Week 12
Baseline, Week 12
Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12
Baseline, Week 12
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)

Placebo (Two-Step Titration)

PLACEBO COMPARATOR

2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.

Drug: PlaceboDevice: Pen auto-injector

Placebo (One-Step Titration)

PLACEBO COMPARATOR

1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12.

Drug: PlaceboDevice: Pen auto-injector

Lixisenatide (Two-Step Titration)

EXPERIMENTAL

2-step initiation regimen of lixisenatide: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12.

Drug: Lixisenatide (AVE0010)Device: Pen auto-injector

Lixisenatide (One-Step Titration)

EXPERIMENTAL

1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to Week 12.

Drug: Lixisenatide (AVE0010)Device: Pen auto-injector

Interventions

Lixisenatide (AVE0010)DRUG

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

Lixisenatide (One-Step Titration)Lixisenatide (Two-Step Titration)

PlaceboDRUG

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

Placebo (One-Step Titration)Placebo (Two-Step Titration)

Pen auto-injectorDEVICE

Also known as: OptiClik®

Lixisenatide (One-Step Titration)Lixisenatide (Two-Step Titration)Placebo (One-Step Titration)Placebo (Two-Step Titration)

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 2 months at the time of the screening visit, not treated with any antidiabetic agent

You may not qualify if:

HbA1c less than (\<) 7 percent (%) or greater than (\>) 10%
At the time of screening age \< legal age of majority
Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
Type 1 diabetes mellitus
Type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study
Fasting plasma glucose at screening \>250 milligram per deciliter (mg/dL) (\>13.9 millimole per liter \[mmol/L\])
Body mass index less than or equal to (\<=) 20 kilogram per square meter (kg/m\^2)
Weight change of more than 5 kg during the previous 3 months
History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
History of metabolic acidosis, including diabetic ketoacidosis within the previous year
Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within the previous 3 months
History of myocardial infarction, stroke, or heart failure requiring hospitalization within the previous 6 months
Known history of drug or alcohol abuse within the previous 6 months
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 with a resting supine systolic or diastolic blood pressure \>180 millimeter of mercury (mmHg) or \>95 mmHg, respectively
+9 more criteria

Contact the study team to confirm eligibility.