Phase 3 · Exenatide

GETGOAL-X trial results

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

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (percentage of hemoglobin), Baseline, Week 24. Lixisenatide: -0.79; Exenatide: -0.96.

Participants
639
Status
completed
Completed
2010-11
Sponsor
Sanofi

As posted on ClinicalTrials.gov (NCT00707031), updated at source Dec 2, 2016. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What GETGOAL-X measured first

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24percentage of hemoglobin · Baseline, Week 24 · least squares mean
Lixisenatiden=295Exenatiden=297
-0.79(0.053)-0.96(0.054)
Side effects by arm

Side effects in GETGOAL-X

Percent of participants affected, First dose of study drug up to 3 days after the last dose administration, for up to 116 weeks. The most common events the registry lists.

EventLixisenatideExenatide
Any serious event8.2%7%
Nausea28.6%37.7%
Diarrhoea15.1%17.1%
Vomiting12.9%15.5%
Nasopharyngitis15.4%11.1%
Hypoglycaemia5.7%15.2%
Headache14.5%9.8%
Influenza9.1%10.1%
Dizziness6.6%9.8%
Dyspepsia6%6.6%
Bronchitis6%6%
Hypertension6%3.2%
Arthralgia6%4.1%
Back pain6%5.1%
Upper respiratory tract infection5.7%4.1%
Constipation4.4%5.4%
Abdominal pain upper5%4.4%
Fatigue5%2.8%
Secondary outcomes

What else it measured

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24mmol/L · Baseline, Week 24 · least squares mean
Lixisenatiden=310Exenatiden=301
-1.22(0.116)-1.45(0.119)
Change From Baseline in Body Weight at Week 24kilogram · Baseline, Week 24 · least squares mean
Lixisenatiden=295Exenatiden=296
-2.96(0.231)-3.98(0.232)
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24percentage of participants · Week 24 · number
Lixisenatiden=295Exenatiden=297
48.549.8
Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24percentage of participants · Week 24 · number
Lixisenatiden=295Exenatiden=297
28.535.4
Percentage of Patients Requiring Rescue Therapy During Main 24-Week Periodpercentage of participants · Baseline up to Week 24 · number
Lixisenatiden=315Exenatiden=315
2.23.8
The trial

How GETGOAL-X was run

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 \[PAGI-QOL\]).

  • Lixisenatide: 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.
  • Exenatide: 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.
Who could join the trial

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 per 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 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 * Laboratory findings at the time of screening: aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase: \>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 \<100 000/ mm\^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody; and positive serum pregnancy test in females of childbearing 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...

Published papers

Papers from GETGOAL-X

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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