Skip to content

Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name GETGOAL-M

NCTNCT00712673 (opens ClinicalTrials.gov in a new tab)Other idEFC6014Other idEudraCT 2007-005880-80
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
680 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Double masking
Countries
16 countries

United States, Australia, Canada, Chile, Croatia, Czechia, Germany, Mexico, Morocco, Philippines, Romania, Russia, South Africa, Spain, Ukraine, Venezuela

Start
Jun 2008
Primary completion
Mar 2011
Completion
Mar 2011
First posted
10 Jul 2008 (estimated)
Last update posted
15 Dec 2016 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009201020112012
  1. Ph 3

    GETGOAL-M

    NCT00712673

    Jun 2008 to Mar 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Lixisenatide (AVE0010)Drug
  • PlaceboDrug
  • Pen auto-injectorDevice
  • MetforminDrug

Arms4

  • Experimental

    Lixisenatide (Morning Injection)

    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.

  • Experimental

    Lixisenatide (Evening Injection)

    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.

  • Placebo comparator

    Placebo (Morning Injection)

    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.

  • Placebo comparator

    Placebo (Evening Injection)

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline, Week 24

    Registry description

    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.

Secondary outcomes(16)

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day 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.

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

    Time frame · Baseline, Week 24

    Registry description

    The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the 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.

  3. Change From Baseline in Body Weight at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. 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.

  4. Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day 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.

  5. Change From Baseline in 2-Hour Postprandial Plasma Insulin (PPI) at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the 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.

  6. Change From Baseline in Fasting Proinsulin at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day 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.

  7. Change From Baseline in 2-Hour Postprandial Proinsulin at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day 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.

  8. Change From Baseline in Fasting C-Peptide at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day 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.

  9. Change From Baseline in 2-Hour Postprandial C-Peptide at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day 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.

  10. Change From Baseline in Fasting Glucagon at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day 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.

  11. Change From Baseline in 2-Hour Postprandial Glucagon at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day 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.

  12. Change From Baseline in Adiponectin at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change was calculated by subtracting baseline value from Week 24 value. 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.

  13. Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24

    Time frame · Baseline, Week 24

    Registry description

    Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin \[micro unit per milliliter\]) divided by (FPG \[mmol/L\] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after 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.

  14. Percentage of Patients Requiring Rescue Therapy During the Main 24-Week Period

    Time frame · Baseline up to Week 24

    Registry description

    Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG \>270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG \>240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG \>200 mg/dL (11.1 mmol/L) or HbA1c \>8.5%. 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.

  15. Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24

    Time frame · Week 24

    Registry description

    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.

  16. Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24

    Time frame · Week 24

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 24

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

GroupValue (percentage of hemoglobin)Spread
Placebo (Combined)-0.380.075
Lixisenatide (Morning Injection)-0.870.065
Lixisenatide (Evening Injection)-0.750.066
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

GroupValue (mmol/L)Spread
Placebo (Combined)-0.250.166
Lixisenatide (Morning Injection)-1.190.145
Lixisenatide (Evening Injection)-0.810.146
Secondary outcomeLeast squares mean· Baseline, Week 24

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

GroupValue (mmol/L)Spread
Placebo (Morning Injection)-1.410.588
Lixisenatide (Morning Injection)-5.920.415
Secondary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in Body Weight at Week 24

GroupValue (kilogram)Spread
Placebo (Combined)-1.640.269
Lixisenatide (Morning Injection)-2.010.234
Lixisenatide (Evening Injection)-2.020.236
Secondary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24

GroupValue (pmol/L)Spread
Placebo (Combined)-6.233.254
Lixisenatide (Morning Injection)-5.092.812
Lixisenatide (Evening Injection)-1.882.862
Secondary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in 2-Hour Postprandial Plasma Insulin (PPI) at Week 24

GroupValue (pmol/L)Spread
Placebo (Morning Injection)-25.6738.028
Lixisenatide (Morning Injection)-87.2424.885
Secondary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in Fasting Proinsulin at Week 24

GroupValue (pmol/L)Spread
Placebo (Morning Injection)-3.782.246
Lixisenatide (Morning Injection)-7.781.414
Secondary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in 2-Hour Postprandial Proinsulin at Week 24

GroupValue (pmol/L)Spread
Placebo (Morning Injection)-6.835.253
Lixisenatide (Morning Injection)-18.883.406

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo (Morning Injection)2-step initiation morning regimen of volume matching placebo.–2 / 8545 / 85
Placebo (Evening Injection)2-step initiation evening regimen of volume matching placebo.–9 / 8550 / 85
Placebo (Combined)Included all patients who received 2-step initiation morning and evening regimen of volume matching placebo.–11 / 17095 / 170
Lixisenatide (Morning Injection)2-step initiation morning regimen of lixisenatide.–21 / 255182 / 255
Lixisenatide (Evening Injection)2-step initiation evening regimen of lixisenatide.–26 / 255169 / 255
Lixisenatide (Combined)Included all patients who received 2-step initiation morning and evening regimen of lixisenatide.–47 / 510351 / 510

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Randomized controlled trial · 2016

5 results

Efficacy of lixisenatide in patients with type 2 diabetes: A post hoc analysis of patients with diverse β-cell function in the GetGoal-M and GetGoal-S trials.

Yabe et al. 2016Journal of diabetes and its complicationscited by 16

PMID 27267268DOI 10.1016/j.jdiacomp.2016.05.018PUB-27267268

Full text at the publisher5 results
Publisher pageSee results (5)

PubMed tag: none · 2016

3 results

Postprandial Glucagon Reductions Correlate to Reductions in Postprandial Glucose and Glycated Hemoglobin with Lixisenatide Treatment in Type 2 Diabetes Mellitus: A Post Hoc Analysis.

Ahrén et al. 2016Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 4

PMID 27319011PMC5014785DOI 10.1007/s13300-016-0179-6PUB-27319011

Free to read · publisher termsCC BY-NC3 results
Read at sourceSee results (3)

Indexing hint: Randomized controlled trial · 2013

14 results

Efficacy and safety of lixisenatide once-daily morning or evening injections in type 2 diabetes inadequately controlled on metformin (GetGoal-M).

Ahrén et al. 2013Diabetes carecited by 148

PMID 23536584PMC3747937DOI 10.2337/dc12-2006PUB-23536584

Free to read · publisher termsCC BY-NC-ND14 results
Read at sourceSee results (14)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Laboratory findings at the time of screening: aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase: \>2 times upper limit of normal (ULN) laboratory range; amylase and/or lipase: \>3 times ULN; total bilirubin: \>1.5 times ULN (except in case of Gilbert's syndrome); Hemoglobin \<11 gram/deciliter and/or neutrophils \<1500 per cubic millimeter (mm\^3) and/or platelets \<100 000/mm\^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody; positive serum pregnancy test in females of child bearing potential * Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram, or vital signs at the time of screening that, in the judgment of the investigator or any sub-investigator, precludes safe completion of the study or constrains efficacy assessment * Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements \[such as scheduled visits, being able to do self-injections\]; likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol) * Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (for example, sulfonylurea, alpha glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, dipeptidyl-peptidase-4 inhibitors, insulin) within 3 months prior to the time of screening * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening * Use of any investigational drug within 3 months prior to study * Any previous treatment with lixisenatide or participation in a previous study with lixisenatide * Renal impairment defined with creatinine \>1.4 mg/dL in women and creatinine \>1.5 mg/dL in men * Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening * Allergic reaction to any glucagon-like peptide-1(GLP-1) agonist in the past (for example, exenatide, liraglutide) or to metacresol * Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (\>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator

PepBank is a research reference. Talk to a doctor before you use any peptide.