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Type 2 DiabetesPhase 3GetGoal-ONCT01798706

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

A Phase 3 study testing Lixisenatide (AVE0010) and Antidiabetic background therapy in people with Type 2 Diabetes, run by Sanofi at 83 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Lixisenatide (AVE0010) and Antidiabetic background therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
83 sitesin 13 countries
Study dates
Jun 2013to Feb 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Older participants, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic pharmaceutical treatment regimen.
  • Signed written informed consent.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

83 sites in 13 countries.

83 sites in 13 countries

United States14 sites

  • Investigational Site Number 840017

    Biloxi, Mississippi, 39531

  • Investigational Site Number 840014

    Canal Fulton, Ohio, 44614

  • Investigational Site Number 840002

    Des Moines, Iowa, 50314

  • Investigational Site Number 840006

    Fargo, North Dakota, 58103

  • Investigational Site Number 840010

    La Jolla, California, 92037

  • Investigational Site Number 840003

    Miami, Florida, 33156

  • Investigational Site Number 840012

    Miami, Florida, 33156

  • Investigational Site Number 840007

    Milwaukee, Wisconsin, 53209

  • Investigational Site Number 840015

    Norwalk, California, 90650

  • Investigational Site Number 840009

    Omaha, Nebraska, 68131

  • Investigational Site Number 840008

    Oxon Hill, Maryland, 20745

  • Investigational Site Number 840004

    Rockville, Maryland, 20852

  • Investigational Site Number 840016

    Salisbury, North Carolina, 28144

  • Investigational Site Number 840011

    St. George, Utah, 84790

Other trials in United States

Canada8 sites

  • Investigational Site Number 124003

    Hamilton, L8L 5G8

  • Investigational Site Number 124007

    London, N6B 2E3

  • Investigational Site Number 124001

    Saint Romuald, G6W 5M6

  • Investigational Site Number 124002

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124005

    Vancouver, V5Z 1M9

  • Investigational Site Number 124006

    Vancouver, V5Z 1M9

  • Investigational Site Number 124008

    Westmount, H3Z 1E5

  • Investigational Site Number 124004

    Winnipeg, R3E 3P4

Other trials in Canada

Germany8 sites

  • Investigational Site Number 276005

    Dresden, 01307

  • Investigational Site Number 276004

    Essen, 45359

  • Investigational Site Number 276002

    München, 80639

  • Investigational Site Number 276001

    Münster, 48145

  • Investigational Site Number 276006

    Pirna, 01796

  • Investigational Site Number 276007

    Pohlheim, 35415

  • Investigational Site Number 276008

    Potsdam, 14469

  • Investigational Site Number 276003

    Saarlouis, 66740

Other trials in Germany

Peru8 sites

  • Investigational Site Number 604001

    Arequipa

  • Investigational Site Number 604011

    Lima, 27

  • Investigational Site Number 604005

    Lima, LIMA 10

  • Investigational Site Number 604003

    Lima, LIMA 14

  • Investigational Site Number 604006

    Lima, LIMA 31

  • Investigational Site Number 604002

    Lima

  • Investigational Site Number 604007

    Lima

  • Investigational Site Number 604008

    Piura

Other trials in Peru

Australia6 sites

  • Investigational Site Number 036002

    Box Hill, 3128

  • Investigational Site Number 036006

    Brookvale, 2100

  • Investigational Site Number 036004

    Camperdown, 2050

  • Investigational Site Number 036005

    Gosford, 2250

  • Investigational Site Number 036001

    Heidelberg, 3081

  • Investigational Site Number 036003

    Parkville, 3050

Other trials in Australia

Spain6 sites

  • Investigational Site Number 724001

    Alzira, 46600

  • Investigational Site Number 724005

    Barcelona, 08035

  • Investigational Site Number 724006

    Hostalets de Balenyà, 08550

  • Investigational Site Number 724003

    Madrid, 28046

  • Investigational Site Number 724002

    Sanlúcar de Barrameda, 11540

  • Investigational Site Number 724004

    Santiago de Compostela, 15706

Other trials in Spain

Sweden6 sites

  • Investigational Site Number 752006

    Gothenburg, 405 45

  • Investigational Site Number 752007

    Härnösand, 871 82

  • Investigational Site Number 752002

    Lund, 22221

  • Investigational Site Number 752004

    Malmö, 211 52

  • Investigational Site Number 752003

    Stockholm, 111 57

  • Investigational Site Number 752001

    Stockholm, 171 76

Other trials in Sweden

Bulgaria5 sites

  • Investigational Site Number 100002

    Plovdiv, 4002

  • Investigational Site Number 100005

    Plovdiv, 4002

  • Investigational Site Number 100003

    Sofia, 1632

  • Investigational Site Number 100004

    Stara Zagora, 6000

  • Investigational Site Number 100001

    Varna, 9000

Other trials in Bulgaria

Denmark5 sites

  • Investigational Site Number 208005

    Esbjerg, 6700

  • Investigational Site Number 208001

    København NV, 2400

  • Investigational Site Number 208004

    København S, 2300

  • Investigational Site Number 208002

    Slagelse, 4200

  • Investigational Site Number 208003

    Svendborg, 5700

Other trials in Denmark

Norway5 sites

  • Investigational Site Number 578001

    Hønefoss, 3515

  • Investigational Site Number 578005

    Kongsvinger, 2212

  • Investigational Site Number 578003

    Oslo

  • Investigational Site Number 578006

    Stavanger, 4095

  • Investigational Site Number 578004

    Trondheim, 7012

Other trials in Norway

Poland5 sites

  • Investigational Site Number 616004

    Gdansk, 80-858

  • Investigational Site Number 616003

    Krakow, 31-024

  • Investigational Site Number 616001

    Poznan, 61-665

  • Investigational Site Number 616002

    Ruda Śląska, 41-709

  • Investigational Site Number 616006

    Szczecin, 70-506

Other trials in Poland

United Kingdom4 sites

  • Investigational Site Number 826003

    Bexhill-on-Sea, TN39 4SP

  • Investigational Site Number 826001

    Glasgow

  • Investigational Site Number 826002

    Irvine, KA12 0AY

  • Investigational Site Number 826004

    Trowbridge, BA14 8QA

Other trials in United Kingdom

South Africa3 sites

  • Investigational Site Number 710003

    Cape Town, 7500

  • Investigational Site Number 710002

    Cape Town, 7530

  • Investigational Site Number 710004

    Somerset West, 7130

Other trials in South Africa

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter, 24 Week Study Assessing the Safety and Efficacy of Lixisenatide in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Diabetes Treatment Regimen

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.
Read more

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.
Read the detailed description

Approximately 31 weeks including 24 week treatment period.

Conditions
Type 2 Diabetes
Being tested
Lixisenatide (AVE0010), Placebo, Antidiabetic background therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lixisenatide (AVE0010)Drug

    Also called Lyxumia

    Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning

    Route of administration: Subcutaneous injection

  • PlaceboDrug

    Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning

    Route of administration: Subcutaneous injection

  • Antidiabetic background therapyDrug

    Participants received a stable regimen of anti-diabetic background therapy for at least 3 months prior to screening, during the placebo run-in period and the 24 week treatment period. Allowed background antidiabetic therapy included metformin, sulfonylurea (except glibenclamide >10 mg, gliclazide >160 mg), meglitinides (except repaglinide >6 mg), pioglitazone and basal insulin. Insulin glargine, neutral protamine hagedorn (NPH) insulin, detemir, lente and ultralente were considered as basal insulin.

Study groups in NCT01798706
Study groupRoleWhat they receive
LixisenatideExperimentalLixisenatide 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.
Receives: Drug: Lixisenatide (AVE0010); Drug: Antidiabetic background therapy
PlaceboPlacebo comparatorPlacebo (matched to lixisenatide) QD for 24 Weeks.
Receives: Drug: Placebo; Drug: Antidiabetic background therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Change in HbA1c From Baseline to Week 24

    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.

    Measured: Baseline, Week 24

Secondary outcomes (10)

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

    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.

    Measured: Baseline, Week 24

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

    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.

    Measured: Baseline, Week 24

  3. Change in Body Weight From Baseline to Week 24

    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.

    Measured: Baseline, Week 24

  4. Change in FPG From Baseline to Week 24

    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.

    Measured: Baseline, Week 24

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

    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%.

    Measured: Baseline up to Week 24

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

    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.

    Measured: Baseline, Week 24

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

    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.

    Measured: Baseline, Week 24

  8. Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia

    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.

    Measured: First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)

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

    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.

    Measured: Week 24

  10. Percentage of Participants With Gastrointestinal Disorders

    Measured: Up to Day 171

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01798706
Sponsor's protocol ID
EFC12703
Other IDs
2012-003292-19, U1111-1132-9156
Acronym
GetGoal-O
Status last verified
Mar 2017
First submitted
22 Feb 2013
Last updated
18 Apr 2017
Data monitoring committee
Yes

Publications

  • Meneilly GS, Roy-Duval C, Alawi H, Dailey G, Bellido D, Trescoli C, Manrique Hurtado H, Guo H, Pilorget V, Perfetti R, Simpson H; GetGoal-O Trial Investigators. Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial. Diabetes Care. 2017 Apr;40(4):485-493. doi: 10.2337/dc16-2143. Epub 2017 Feb 10.

    PubMed 28188240

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lixisenatide (AVE0010) and Antidiabetic background therapy in people with Type 2 Diabetes, run by Sanofi at 83 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Canada, Germany, Peru, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change in HbA1c From Baseline to Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01798706, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.

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