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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name GETGOAL-F1

NCTNCT00763451 (opens ClinicalTrials.gov in a new tab)Other idEFC10743Other id2008-001002-16Other id2008

Overview

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

United States, Brazil, Chile, Colombia, Estonia, Germany, Italy, Lithuania, Malaysia, Mexico, Philippines, Poland, Romania, Slovakia, Ukraine

Start
Sept 2008
Primary completion
Jan 2011
Completion
Jan 2011
First posted
1 Oct 2008 (estimated)
Last update posted
14 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-F1

    NCT00763451

    Sept 2008 to Jan 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 when added to metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction when it is used in two steps dose titration regimen at Week 24. Secondary objectives are to assess the effects of lixisenatide when added to metformin on glycemic control in comparison to placebo in terms of HbA1c reduction when it is used in a one-step dose titration regimen, the percentage of patients with HbA1c less than 7 percent or less than or equal to 6.5%, body weight, fasting plasma glucose (FPG); to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Interventions

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

Arms4

  • Experimental

    Lixisenatide (Two-Step Titration)

    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.

  • Experimental

    Lixisenatide (One-Step Titration)

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

  • Placebo comparator

    Placebo (Two-Step Titration)

    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.

  • Placebo comparator

    Placebo (One-Step Titration)

    1-step initiation regimen of volume matching placebo: 10 mcg QD for 2 weeks, then 20 mcg QD up to the 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 mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. The "Placebo (Two-step Titration)" and "Placebo (One-step Titration)" Arms/Groups were combined as pre-specified in the study protocol

Secondary outcomes(5)
  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 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.

  3. 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.

  4. 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.

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

    Time frame · Baseline up to Week 24

    Registry description

    Routine fasting self-measured 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.

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)-0.420.099
Lixisenatide (Two-Step Titration)-0.830.099
Lixisenatide (One-Step Titration)-0.920.101
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)0.110.209
Lixisenatide (Two-Step Titration)-0.560.208
Lixisenatide (One-Step Titration)-0.530.212
Secondary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in Body Weight at Week 24

GroupValue (kilogram)Spread
Placebo (Combined)-1.630.385
Lixisenatide (Two-Step Titration)-2.680.385
Lixisenatide (One-Step Titration)-2.630.389
Secondary outcomeNumber· Week 24

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

GroupValue (percentage of participants)
Placebo (Combined)24.1
Lixisenatide (Two-Step Titration)42.1
Lixisenatide (One-Step Titration)47.4
Secondary outcomeNumber· Week 24

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

GroupValue (percentage of participants)
Placebo (Combined)7.6
Lixisenatide (Two-Step Titration)20.4
Lixisenatide (One-Step Titration)25.6
Secondary outcomeNumber· Baseline up to Week 24

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

GroupValue (percentage of participants)
Placebo (Combined)4.4
Lixisenatide (Two-Step Titration)3.1
Lixisenatide (One-Step Titration)1.3
Other pre specified outcomeNumber· Baseline, Week 24

Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24

GroupValue (percentage of participants)
Placebo (Combined)15.2
Lixisenatide (Two-Step Titration)25.8
Lixisenatide (One-Step Titration)19.6
Other pre specified outcomeNumber· First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks

Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia

GroupValue (participants)
Placebo (Combined)12
Lixisenatide (Two-Step Titration)12
Lixisenatide (One-Step Titration)6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo (Two-step Titration)2-step initiation regimen of volume matching placebo.–13 / 7951 / 79
Placebo (One-step Titration)1-step initiation regimen of volume matching placebo.–9 / 8153 / 81
Placebo (Combined)Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.–22 / 160104 / 160
Lixisenatide (Two-step Titration)2-step initiation regimen of lixisenatide.–21 / 161119 / 161
Lixisenatide One-step Titration1-step initiation regimen of lixisenatide.–16 / 161101 / 161
Lixisenatide (Combined)Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.–37 / 322220 / 322

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

Studies2

Studies that cite this trial.

Studies with results

2 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

Indexing hint: Randomized controlled trial · 2014

14 results

Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal-F1).

Bolli et al. 2014Diabetic medicine : a journal of the British Diabetic Associationcited by 108

PMID 24117597DOI 10.1111/dme.12328PUB-24117597

Full text at the publisher14 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedAmbery P, Donner TW, Biswas N, Donaldson J, Parkin J, Dayan CM. Efficacy and safety of low-dose otelixizumab anti-CD3 monoclonal antibody in preserving C-peptide secretion in adolescent type 1 diabetes: DEFEND-2, a randomized, placebo-controlled, double-blind, multi-centre study. Diabet Med. 2014 Apr;31(4):399-402. doi: 10.1111/dme.12361. Epub 2013 Dec 6. PMID 24236828

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 at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 gram/day for at least 3 months prior to screening visit Exclusion Criteria: * 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 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 less than or equal to (\<)20 kilogram per square meter (kg/m\^2) * Weight change of more than 5 kg during the 3 months preceding the 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 or diastolic blood pressure \>180 millimeter of mercury (mmHg) or \>95 mmHg, respectively * Laboratory findings at the time of screening: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP): \>2 times upper limit of the 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 \<100000/mm\^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb) and positive serum pregnancy test in females of childbearing potential * Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG) 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 oral or injectable antidiabetic or hypoglycemic agents other than metformin (for example, sulfonylurea, alpha glucosidase inhibitor, thiazolidinedione, rimonabant, exenatide, dipeptidylpeptidase-4 (DPP-IV) inhibitor, insulin) within 3 months prior to the time of screening * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one 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 any 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

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