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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

Short name GetGoal-O

NCTNCT01798706 (opens ClinicalTrials.gov in a new tab)Other idEFC12703Other id2012-003292-19Other idU1111-1132-9156
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Australia, Bulgaria, Canada, Denmark, Germany, Norway, Peru, Poland, South Africa, Spain, Sweden, United Kingdom

Start
Jun 2013
Primary completion
Feb 2015
Completion
Feb 2015
First posted
26 Feb 2013 (estimated)
Last update posted
18 Apr 2017
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 3

    GetGoal-O

    NCT01798706

    Jun 2013 to Feb 2015

Registry summary

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

Primary objective: \- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen. Main secondary objective: \- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG \< 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects). Other secondary objectives: * To assess the effect of lixisenatide compared to placebo after 24-week treatment on: * Fasting plasma glucose (FPG); * During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion; * 7-point Self-monitored plasma glucose (SMPG) profile; * Body weight; * Change in total daily dose of basal insulin (if taken); * Percentage of participants requiring rescue therapy * Safety and tolerability; * To assess lixisenatide pharmacokinetic profile; * To assess anti-lixisenatide antibody development.

Interventions

  • Lixisenatide (AVE0010)Drug
  • PlaceboDrug
  • Antidiabetic background therapyDrug

Arms2

  • Experimental

    Lixisenatide

    Lixisenatide 10 mcg once daily (QD) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.

  • Placebo comparator

    Placebo

    Placebo (matched to lixisenatide) QD for 24 Weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Absolute Change in HbA1c From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed=participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.

Secondary outcomes(10)

  1. Change in 2-Hour PPG From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry description

    The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.

  2. Change in Average 7-point SMPG Profiles From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry description

    Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.

  3. Change in Body Weight From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.

  4. Change in FPG From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry description

    Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.

  5. Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period

    Time frame · Baseline up to Week 24

    Registry description

    Routine fasting 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 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 \>9%.

  6. Change in Plasma Glucose Excursions From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry description

    Plasma glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the liquid standardized breakfast meal test, before study drug administration. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.

  7. Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)

    Time frame · Baseline, Week 24

    Registry description

    Change in basal insulin dose was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.

  8. Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia

    Time frame · First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)

    Registry description

    Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.

  9. Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia

    Time frame · Week 24

    Registry description

    The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.

  10. Percentage of Participants With Gastrointestinal Disorders

    Time frame · Up to Day 171

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 in HbA1c From Baseline to Week 24

GroupValue (percentage of hemoglobin)Spread
Lixisenatide-0.570.075
Placebo0.060.072
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in 2-Hour PPG From Baseline to Week 24

GroupValue (mmol/L)Spread
Lixisenatide-5.120.392
Placebo-0.070.393
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in Average 7-point SMPG Profiles From Baseline to Week 24

GroupValue (mmol/L)Spread
Lixisenatide-1.150.186
Placebo-0.190.189
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in Body Weight From Baseline to Week 24

GroupValue (kg)Spread
Lixisenatide-1.470.241
Placebo-0.160.228
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in FPG From Baseline to Week 24

GroupValue (mmol/L)Spread
Lixisenatide-0.30.224
Placebo0.010.218
Secondary outcomeNumber· Baseline up to Week 24

Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period

GroupValue (percentage of participants)
Lixisenatide2.9
Placebo10.4
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in Plasma Glucose Excursions From Baseline to Week 24

GroupValue (mmol/L)Spread
Lixisenatide-4.710.331
Placebo-0.250.331
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)

GroupValue (units)Spread
Lixisenatide-2.971.145
Placebo-1.31.076

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LixisenatideLixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.(Median exposure: 169 days)–8 / 17689 / 176
PlaceboPlacebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. (Median exposure: 169 days)–10 / 17458 / 174

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
Source linkSee results (15)

Indexing hint: Randomized controlled trial · 2017

4 results

Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial.

Meneilly et al. 2017Diabetes carecited by 30

PMID 28188240DOI 10.2337/dc16-2143PUB-28188240

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria : * Older participants, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic pharmaceutical treatment regimen. * Signed written informed consent. Exclusion criteria: * At screening HbA1c ≤7.0% or \>10% (Acknowledging that the threshold of 7% may not be appropriate for all older participants and that this was the responsibility of the investigator to include the participant based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia). * At screening participants on both basal insulin and sulfonylurea or basal insulin and meglitinides. * At screening FPG \>250 mg/dL (\>13.9 mmol/L). * Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit. * Type 2 diabetes mellitus diagnosed less than 1 year prior to screening. * Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening. * Treatment within the 3 months preceding the screening with other anti-diabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea (except glibenclamide \>10mg, gliclazide \>160mg), meglitinides (except repaglinide \>6mg), pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population. * Participants who had been on an approved or an investigational Glucagon-like peptide 1 (GLP-1) medication (exenatide, liraglutide, lixisenatide or others). * History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening. * BMI \<22 or \>40 kg/m\^2. * Malnutrition assessed clinically by the investigator or any sub-investigator and by Mini-Nutritional Assessment-Short Form (MNA-SF) score \<12 in countries (the judgment of the investigator prevails on questionnaires scores). * Cognitive disorder and dementia assessed clinically by the investigator or any sub investigator and by Mini Mental State Examination (MMSE) score \<24 (the judgment of the investigator prevails on questionnaires scores), or any neurologic disorder that affected the participant's ability to participate in the study. * Participant who had a glomerular filtration rate (eGFR) (using the Modification of Diet in Renal Disease (MDRD) formula \<30ml/min/1.73m\^2). * Participant with severe or uncontrolled disease, or any clinically significant abnormality identified on physical examination or investigational clinical procedure that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrains efficacy assessment. * Laboratory findings at the time of screening: * Amylase and/or lipase: \>3 times the upper limit of the normal (ULN) laboratory range * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times ULN * Calcitonin \>20 pg/mL (5.9 pmol/L). * Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) and not controlled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening. * History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease. * Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposed to medullary thyroid cancer (e.g., multiple endocrine neoplasia syndromes). The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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