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Type 2 Diabetes MellitusPhase 3NCT00976937

24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

A Phase 3 study testing Lixisenatide (AVE0010), Pen auto-injector and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Sanofi at 92 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

The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index [BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic patients less than 50 years of age, over a period of… Read more about this study

Who is it for?
Ages 18 to 49 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Lixisenatide (AVE0010), Pen auto-injector and Sitagliptin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
319 participants
Where
92 sitesin 13 countries
Study dates
Aug 2009to Mar 2011
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 18 to 49 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 (g/day) for at least 3 months prior to the screening visit
  • Patients with obesity (BMI greater than equal to [>=] 30 kg/m^2) and aged from 18 years to less than 50 years

Who cannot join

  • HbA1c less than (<) 7.0 percent (%) or HbA1c greater than (>) 10% at screening
  • Type 1 diabetes mellitus
  • Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
  • FPG at screening >250 milligram/deciliter (mg/dL) (>13.9 millimole/ liter [mmol/L])
  • 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, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for example, multiple endocrine neoplasia syndromes)
Show all 24Show fewer
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
  • Hemoglobinopathy or hemolytic anemia or 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
  • 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 could have precludes safe completion of the study or constrains efficacy assessment such as major systemic diseases, presence of clinically significant diabetic retinopathy 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 or diastolic blood pressure >180 millimeter of mercury (mmHg) or >110 mmHg, respectively
  • Laboratory findings at the time of screening : Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range; alanine aminotransferase (ALT): >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 (HBsAg) and/or Hepatitis C antibody (HCAb), positive serum pregnancy test in females of childbearing potential, and calcitonin >=20 picogram per milliliter (pg/mL) (5.9 picomole per liter)
  • Patients who are considered by the investigator or any sub-investigator as inappropriate for the 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 other oral or injectable antidiabetic or hypoglycemic agents than metformin (for example, sulfonylurea, alpha glucosidase inhibitor, thiazolidinedione, exenatide, dipeptidyl peptidase IV (DPP-IV) inhibitors, insulin) within 3 months prior to the time of screening
  • History of bariatric surgery, anti-obesity treatment, or unstable diet 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 screening
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
  • Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)
  • Allergic reaction to any glucagon like peptide-1 (GLP 1) agonist in the past (for example, exenatide, liraglutide) or to metacresol
  • History of a serious hypersensitivity reaction to sitagliptin
  • Moderate or severe renal impairment (creatinine clearance inferior to 50 milliliter/minute [mL/min])
  • Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in period (>2 injections missed or >2 capsules missed); and patient with any adverse event which could have precludes the inclusion in the study, as assessed by the investigator

Trial locations and contacts

92 sites in 13 countries.

92 sites in 13 countries

United States21 sites

  • Sanofi-Aventis Investigational Site Number 840025

    Altoona, Pennsylvania, 16602

  • Sanofi-Aventis Investigational Site Number 840011

    Anaheim, California, 92801

  • Sanofi-Aventis Investigational Site Number 840021

    Augusta, Georgia, 30909

  • Sanofi-Aventis Investigational Site Number 840002

    Baton Rouge, Louisiana, 70808

  • Sanofi-Aventis Investigational Site Number 840009

    Brentwood, Tennessee, 37207

  • Sanofi-Aventis Investigational Site Number 840006

    Butte, Montana, 59701

  • Sanofi-Aventis Investigational Site Number 840016

    Chicago, Illinois, 60610

  • Sanofi-Aventis Investigational Site Number 840018

    Chicago, Illinois, 60616

  • Sanofi-Aventis Investigational Site Number 840031

    Clarkston, Michigan, 48346

  • Sanofi-Aventis Investigational Site Number 840008

    Dallas, Texas, 75230

  • Sanofi-Aventis Investigational Site Number 840001

    Evansville, Indiana, 47714

  • Sanofi-Aventis Investigational Site Number 840020

    Florissant, Missouri, 63031

  • Sanofi-Aventis Investigational Site Number 840004

    Medford, Oregon, 97504

  • Sanofi-Aventis Investigational Site Number 840022

    Mesa, Arizona, 85206

  • Sanofi-Aventis Investigational Site Number 840019

    Montgomery, Alabama, 36109

  • Sanofi-Aventis Investigational Site Number 840003

    Muscle Shoals, Alabama, 35661

  • Sanofi-Aventis Investigational Site Number 840014

    Paramount, California, 90723

  • Sanofi-Aventis Investigational Site Number 840026

    Perrysburg, Ohio, 43551

  • Sanofi-Aventis Investigational Site Number 840027

    Redlands, California, 92374

  • Sanofi-Aventis Investigational Site Number 840007

    Roswell, Georgia, 30076

  • Sanofi-Aventis Investigational Site Number 840010

    San Antonio, Texas, 78229

Other trials in United States

Canada10 sites

  • Sanofi-Aventis Investigational Site Number 124004

    Calgary, T2N 4N1

  • Sanofi-Aventis Investigational Site Number 124008

    Hamilton, L8L 5G8

  • Sanofi-Aventis Investigational Site Number 124005

    London, N6G 2M3

  • Sanofi-Aventis Investigational Site Number 124006

    Montreal, H2W 1R7

  • Sanofi-Aventis Investigational Site Number 124013

    Oakville, L6H 3P1

  • Sanofi-Aventis Investigational Site Number 124002

    Saint Romuald, G6W 5M6

  • Sanofi-Aventis Investigational Site Number 124012

    Thornhill, L4J 8L7

  • Sanofi-Aventis Investigational Site Number 124011

    Toronto

  • Sanofi-Aventis Investigational Site Number 124003

    Vancouver, V5Z 1C6

  • Sanofi-Aventis Investigational Site Number 124007

    Victoria, V8R 6V4

Other trials in Canada

Mexico10 sites

  • Sanofi-Aventis Investigational Site Number 484003

    Aguascalientes, 20230

  • Sanofi-Aventis Investigational Site Number 484010

    Chihuahua City, 31000

  • Sanofi-Aventis Investigational Site Number 484009

    Chihuahua City, 31238

  • Sanofi-Aventis Investigational Site Number 484012

    Df, 03300

  • Sanofi-Aventis Investigational Site Number 484008

    Mérida, 97000

  • Sanofi-Aventis Investigational Site Number 484011

    México, 14050

  • Sanofi-Aventis Investigational Site Number 484001

    Pachuca, 42090

  • Sanofi-Aventis Investigational Site Number 484005

    Pachuca, 42090

  • Sanofi-Aventis Investigational Site Number 484006

    Veracruz, 91700

  • Sanofi-Aventis Investigational Site Number 484002

    Zapopan, 44030

Other trials in Mexico

Romania8 sites

  • Sanofi-Aventis Investigational Site Number 642004

    Bacau, 600164

  • Sanofi-Aventis Investigational Site Number 642006

    Bucharest, 020475

  • Sanofi-Aventis Investigational Site Number 642008

    Bucharest, 022441

  • Sanofi-Aventis Investigational Site Number 642010

    Iași, 700515

  • Sanofi-Aventis Investigational Site Number 642009

    Ploieşti, 100097

  • Sanofi-Aventis Investigational Site Number 642001

    Reşiţa, 320076

  • Sanofi-Aventis Investigational Site Number 642005

    Suceava, 720262

  • Sanofi-Aventis Investigational Site Number 642007

    Timișoara, 300593

Other trials in Romania

Brazil7 sites

  • Sanofi-Aventis Investigational Site Number 076005

    Belém, 66073-000

  • Sanofi-Aventis Investigational Site Number 076001

    Brasília, 71625-009

  • Sanofi-Aventis Investigational Site Number 076006

    Caxias do Sul, 95070-560

  • Sanofi-Aventis Investigational Site Number 076003

    Curitiba, 80060-900

  • Sanofi-Aventis Investigational Site Number 076002

    Rio de Janeiro, 20211-340

  • Sanofi-Aventis Investigational Site Number 076004

    São Paulo, 04024-002

  • Sanofi-Aventis Investigational Site Number 076007

    São Paulo, 05403-000

Other trials in Brazil

Australia6 sites

  • Sanofi-Aventis Investigational Site Number 036006

    Adelaide, 5000

  • Sanofi-Aventis Investigational Site Number 036001

    Box Hill, 3128

  • Sanofi-Aventis Investigational Site Number 036004

    Elizabeth Vale, 5112

  • Sanofi-Aventis Investigational Site Number 036002

    Geelong, 3220

  • Sanofi-Aventis Investigational Site Number 036005

    Meadowbrook, 4131

  • Sanofi-Aventis Investigational Site Number 036003

    Sydney, 2006

Other trials in Australia

Chile5 sites

  • Sanofi-Aventis Investigational Site Number 152001

    Santiago, 7500347

  • Sanofi-Aventis Investigational Site Number 152004

    Santiago, 7500710

  • Sanofi-Aventis Investigational Site Number 152003

    Santiago, 8053095

  • Sanofi-Aventis Investigational Site Number 152002

    Santiago

  • Sanofi-Aventis Investigational Site Number 152005

    Santiago

Other trials in Chile

Guatemala5 sites

  • Sanofi-Aventis Investigational Site Number 320002

    Guatemala City, 01010

  • Sanofi-Aventis Investigational Site Number 320001

    Guatemala City, 01014

  • Sanofi-Aventis Investigational Site Number 320004

    Guatemala City, 1010

  • Sanofi-Aventis Investigational Site Number 320005

    Guatemala City

  • Sanofi-Aventis Investigational Site Number 320006

    Guatemala City

Other trials in Guatemala

Peru5 sites

  • Sanofi-Aventis Investigational Site Number 604005

    Lima, 27

  • Sanofi-Aventis Investigational Site Number 604003

    Lima, Lima 27

  • Sanofi-Aventis Investigational Site Number 604001

    Lima

  • Sanofi-Aventis Investigational Site Number 604002

    Lima

  • Sanofi-Aventis Investigational Site Number 604004

    Lima

Other trials in Peru

Russia5 sites

  • Sanofi-Aventis Investigational Site Number 643002

    Kazan', 420012

  • Sanofi-Aventis Investigational Site Number 643001

    Saint Petersburg, 194358

  • Sanofi-Aventis Investigational Site Number 643003

    Saint Petersburg, 195257

  • Sanofi-Aventis Investigational Site Number 643005

    Saint Petersburg, 198013

  • Sanofi-Aventis Investigational Site Number 643004

    Tyumen, 625023

Other trials in Russia

Poland4 sites

  • Sanofi-Aventis Investigational Site Number 616002

    Bialystok, 15-435

  • Sanofi-Aventis Investigational Site Number 616001

    Bydgoszcz, 85-822

  • Sanofi-Aventis Investigational Site Number 616006

    Warsaw, 02-507

  • Sanofi-Aventis Investigational Site Number 616003

    Wroclaw, 50-127

Other trials in Poland

Germany3 sites

  • Sanofi-Aventis Investigational Site Number 276002

    Berlin, 13125

  • Sanofi-Aventis Investigational Site Number 276005

    Ludwigshafen, 67059

  • Sanofi-Aventis Investigational Site Number 276004

    Schkeuditz, 04435

Other trials in Germany

Ukraine3 sites

  • Sanofi-Aventis Investigational Site Number 804003

    Chernivtsi, 58022

  • Sanofi-Aventis Investigational Site Number 804001

    Kiev, 2091

  • Sanofi-Aventis Investigational Site Number 804004

    Kyiv, 31156

Other trials in Ukraine

About this study

Official title: A Randomized, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin

The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index [BMI] greater than or equal to 30 kilogram per square meter [kg/m^2]) type 2 diabetic patients less than 50 years of age, over a period of 24 weeks of treatment.

The primary objective of this study is to assess the efficacy of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on a composite endpoint of glycemic control in terms of glycosylated hemoglobin (HbA1c) and body weight, at Week 24.

Secondary objectives are to assess the effects of lixisenatide, in comparison to sitagliptin, as an add-on treatment to metformin on absolute changes in HbA1c values and body weight; fasting plasma glucose (FPG); plasma glucose, insulin, C-peptide, glucagon, and proinsulin during a 2-hour standardized meal test; insulin resistance assessed by homeostatic model assessment of insulin resistance (HOMA-IR); beta cell function assessed by homeostatic model assessment of beta-cell function (HOMA-beta); to evaluate safety, tolerability, and anti-lixisenatide antibody development.

Being tested
Lixisenatide (AVE0010), Lixisenatide Placebo, Pen auto-injector, Sitagliptin, Sitagliptin Placebo
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

    Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

  • Lixisenatide PlaceboDrug

    Self-administered by subcutaneous injections once daily within the hour preceding breakfast.

  • Pen auto-injectorDevice

    Also called OptiClik®

  • SitagliptinDrug

    Also called Januvia®

    Administered orally once a day in the morning with or without food at approximately the same time each day.

  • Sitagliptin PlaceboDrug

    Administered orally once a day in the morning with or without food at approximately the same time each day.

  • MetforminDrug

    Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

Study groups in NCT00976937
Study groupRoleWhat they receive
LixisenatideExperimental2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
Receives: Drug: Lixisenatide (AVE0010); Device: Pen auto-injector; Drug: Sitagliptin Placebo; Drug: Metformin
SitagliptinActive comparatorSitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Receives: Drug: Lixisenatide Placebo; Device: Pen auto-injector; Drug: Sitagliptin; Drug: Metformin

What is being measured

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

  1. Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24

    Percentage of patients who met both criteria (HbA1c <7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. 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.

    Measured: Week 24

Secondary outcomes (13)

  1. Absolute Change From Baseline in HbA1c at Week 24

    Absolute change = HbA1c value at Week 24 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.

    Measured: Baseline, Week 24

  2. Change From Baseline in Body Weight at Week 24

    Change was calculated by subtracting baseline value from Week 24 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.

    Measured: Baseline, Week 24

  3. Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24

    The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 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 the study drug or up to the introduction of rescue therapy, whichever is the earliest.

    Measured: Baseline, Week 24

  4. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Change was calculated by subtracting baseline value from Week 24 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.

    Measured: Baseline, Week 24

  5. Change From Baseline in Glucose Excursion at Week 24

    Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 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 the study drug or up to the introduction of rescue therapy, whichever is the earliest.

    Measured: Baseline, Week 24

  6. Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24

    Change was calculated for fasting plasma insulin and 2-hour post prandial plasma insulin by subtracting the baseline value from Week 24 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 the study drug or up to the introduction of rescue therapy, whichever is the earliest.

    Measured: Baseline, Week 24

  7. Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24

    Change was calculated for fasting C-peptide and 2-hour postprandial C-peptide by subtracting the baseline value from Week 24 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.

    Measured: Baseline, Week 24

  8. Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24

    Change was calculated for fasting glucagon and 2-hour postprandial glucagon by subtracting the baseline value from Week 24 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.

    Measured: Baseline, Week 24

  9. Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24

    Change was calculated for fasting proinsulin and 2-hour postprandial proinsulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of the study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.

    Measured: Baseline, Week 24

  10. Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24

    HOMA-IR was derived from FPG and FPI as: (FPI [micro units per milliliter]*FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-IR by subtracting the baseline value from Week 24 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.

    Measured: Baseline, Week 24

  11. Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment-Beta (HOMA-beta) at Week 24

    HOMA-beta was derived from FPG and FPI as: (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the baseline value from Week 24 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.

    Measured: Baseline, Week 24

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

    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.

    Measured: Week 24

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

    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%.

    Measured: Baseline up to Week 24

Timeline

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

  1. First posted15 Sep 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

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
Double blind
Who is masked
Participant, Investigator
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976937
Sponsor's protocol ID
EFC10780
Other IDs
EudraCT:2008-007 334-22
Status last verified
Aug 2016
First submitted
14 Sep 2009
Last updated
11 Oct 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lixisenatide (AVE0010), Pen auto-injector and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Sanofi at 92 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 24 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 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, Canada, Mexico, Romania, Brazil 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. 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 11 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?

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24 (time frame: 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 NCT00976937.

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 11 Oct 2016.

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