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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 in Monotherapy

Short name GETGOAL-MONO

NCTNCT00688701 (opens ClinicalTrials.gov in a new tab)Other idEFC6018Other idEudraCT 2007-005887-29

Overview

Status
Completed
Phase
Phase 3
Enrollment
361 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Quadruple masking
Countries
12 countries

United States, Belgium, India, Israel, Japan, Mexico, Poland, Romania, Russia, South Korea, Tunisia, Ukraine

Start
May 2008
Primary completion
Dec 2009
Completion
Dec 2009
First posted
3 Jun 2008 (estimated)
Last update posted
12 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
200820092010
  1. Ph 3

    GETGOAL-MONO

    NCT00688701

    May 2008 to Dec 2009

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, 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.

Interventions

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

Arms4

  • Placebo comparator

    Placebo (Two-Step Titration)

    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.

  • 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 Week 12.

  • Experimental

    Lixisenatide (Two-Step Titration)

    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.

  • Experimental

    Lixisenatide (One-Step Titration)

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

    Time frame · Baseline, Week 12

    Registry description

    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.

Secondary outcomes(6)
  1. Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12

    Time frame · Baseline, Week 12

    Registry description

    The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day 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.

  2. Change From Baseline in Body Weight at Week 12

    Time frame · Baseline, Week 12

    Registry description

    Change was calculated by subtracting baseline value from Week 12 value. 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.

  3. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

    Time frame · Baseline, Week 12

    Registry description

    Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day 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.

  4. Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12

    Time frame · Week 12

    Registry description

    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.

  5. Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12

    Time frame · Week 12

    Registry description

    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.

  6. Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period

    Time frame · Baseline up to Week 12

    Registry description

    Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG 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 was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: \>270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: \>240 mg/dL (13.3 mmol/L). 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 12

Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

GroupValue (percentage of hemoglobin)Spread
Placebo (Combined)-0.190.121
Lixisenatide (Two-Step Titration)-0.730.116
Lixisenatide (One-Step Titration)-0.850.119
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12

GroupValue (mmol/L)Spread
Placebo (Combined)-0.650.563
Lixisenatide (Two-Step Titration)-4.510.572
Lixisenatide (One-Step Titration)-5.470.549
Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in Body Weight at Week 12

GroupValue (kilogram)Spread
Placebo (Combined)-1.980.341
Lixisenatide (Two-Step Titration)-1.960.326
Lixisenatide (One-Step Titration)-1.920.338
Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

GroupValue (mmol/L)Spread
Placebo (Combined)0.190.255
Lixisenatide (Two-Step Titration)-0.680.247
Lixisenatide (One-Step Titration)-0.890.254
Secondary outcomeNumber· Week 12

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12

GroupValue (percentage of participants)
Placebo (Combined)26.8
Lixisenatide (Two-Step Titration)52.2
Lixisenatide (One-Step Titration)46.5
Secondary outcomeNumber· Week 12

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12

GroupValue (percentage of participants)
Placebo (Combined)12.5
Lixisenatide (Two-Step Titration)31.9
Lixisenatide (One-Step Titration)25.4
Secondary outcomeNumber· Baseline up to Week 12

Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period

GroupValue (percentage of participants)
Placebo (Combined)2.5
Lixisenatide (Two-Step Titration)1.7
Lixisenatide (One-Step Titration)0.8
Other pre specified outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in Glucose Excursion at Week 12

GroupValue (mmol/L)Spread
Placebo (Combined)-0.670.447
Lixisenatide (Two-Step Titration)-3.770.454
Lixisenatide (One-Step Titration)-4.360.436

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.–3 / 6111 / 61
Placebo (One-Step Titration)1-step initiation regimen of volume matching placebo.–2 / 618 / 61
Placebo (Combined)Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.–5 / 12219 / 122
Lixisenatide (Two-Step Titration)2-step initiation regimen of lixisenatide.–1 / 12035 / 120
Lixisenatide (One-Step Titration)1-step initiation regimen of lixisenatide.–0 / 11931 / 119
Lixisenatide (Combined)Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.–1 / 23966 / 239

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

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2024

Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.

Natale et al. 2024The Cochrane database of systematic reviewscited by 32

PMID 38770818PMC11106805DOI 10.1002/14651858.cd015588.pub2PUB-38770818

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2012

14 results

Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono).

Fonseca et al. 2012Diabetes carecited by 167

PMID 22432104PMC3357248DOI 10.2337/dc11-1935PUB-22432104

Free to read · publisher termsCC BY-NC-ND14 results

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 2 months at the time of the screening visit, not treated with any antidiabetic agent Exclusion Criteria: * 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 * Laboratory findings at the time of screening: aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase: \>2 times the upper limit of the normal (ULN) laboratory range; amylase and/or lipase: \>3 ULN; total bilirubin: \>1.5 ULN (except in case of Gilbert's syndrome); hemoglobin \<11 gram/deciliter (g/dL) and/or neutrophils \<1,500 per cubic mm (mm\^3) and/or platelets \<100,000/mm\^3; positive test for Hepatitis B surface antigen and/or hepatitis C antibody * Any clinically significant abnormality identified by physical examination, laboratory tests, electrocardiogram or vital sign at the time of screening that in the judgment of the investigator or any sub investigator precludes safe completion of the study or hinders the efficacy assessment * Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason * Use of systemic glucocorticoids (excluding topical application or inhaled forms) within the previous 3 months * Participation in any previous study with lixisenatide * Use of any investigational drug within 3 months prior to study * End-stage renal disease as defined by a calculated serum creatinine clearance of \<15 milliliter/minute and/or patients on dialysis * 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 the previous 6 months * History of allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past 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: more than 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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