Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT02787551
Eligibility Criteria:
Inclusion criteria :
* Participants with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit.
* Participants who were treated with one of the following GLP-1 receptor agonists for at least 4 months prior to screening visit 1 (V1), and with stable dose for at least 3 months prior to screening visit (V1):
* Liraglutide (Victoza®) 1.8 milligram (mg) QD or 1.2 mg QD, if the 1.8 mg QD dose was not well tolerated according to the Investigator's judgment or
* Exenatide (Byetta®) 10 microgram (µg) BID or of 5 µg BID, if 10 µg BID dose was not well tolerated according to the Investigator's judgment
in combination with metformin (daily dose greater than equal to \[\>=\] 1500 mg/day or maximum tolerated dose \[MTD\]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening.
or
Participants who were treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):
* Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator's judgment,
* Albiglutide (Tanzeum®) 50 mg QW or 30 mg QW, if 50 mg QW was not well tolerated according to Investigator's judgment,
* Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW was not well tolerated according to Investigator's judgment
in combination with metformin (daily dose ≥1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening;
-Signed written informed consent.
Exclusion criteria:
* At screening visit, age \<18.
* Screening HbA1c \<7% and \>9%.
* Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
* Any use of antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria.
* Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin \[\<=10 days\] due to intercurrent illness including gestational diabetes was allowed at the discretion of the study physician).
* Laboratory findings at the time of screening, including:
* Fasting plasma glucose (FPG) \>250 mg/dL (13.9 millimoles per litre \[mmol/L\]),
* Amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN),
* Alanine transaminase or aspartate transaminase \>3 ULN,
* Calcitonin \>=20 pg/mL (5.9 pmol/L),
* Positive pregnancy test.
* Participant who had renal function impairment with estimated glomerular filtration rate \<30mL/min/1.73m\^2 (using the Modification of Diet in Renal Disease formula) or end-stage renal disease.
* Contraindication to use of insulin glargine, or lixisenatide or GLP-1 receptor agonist (Victoza®, Byetta®, Bydureon®, Tanzeum® or Trulicity®) according to local labeling.
* Any contraindication to metformin or pioglitazone or SGLT2 inhibitor use, according to local labeling.
* History of hypersensitivity to insulin glargine, or to any of the excipients.
* History of allergic reaction to any GLP-1 receptor agonist or to meta-cresol.
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia type 2 syndromes).
* History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy.
* Body mass index \<=20 or \>40 kg/m\^2.
Exclusion criteria for the extension period:
* Participants in the FRC arm with a rescue therapy and HbA1c \>8% at week 22.
* Participants in the FRC arm who discontinued prematurely from FRC treatment before week 26.
* Participants in the GLP-1 RA treatment arm after randomization.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02787551
Study Brief:
Protocol Section:
NCT02787551