Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \[SGLT2\] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

Key facts

Study ID

NCT02787551

Run by

Sanofi

People needed

514

Starts

2016-07-06

Expected to finish

2018-11-17

Last updated by the study team

2022-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 8400073 — Fountain Hills, Arizona, United States
• Investigational Site Number 8400047 — Phoenix, Arizona, United States
• Investigational Site Number 8400103 — Bakersfield, California, United States
• Investigational Site Number 8400137 — Fresno, California, United States
• Investigational Site Number 8400043 — Huntington Park, California, United States
• Investigational Site Number 8400124 — Lamont, California, United States
• Investigational Site Number 8400027 — Lancaster, California, United States
• Investigational Site Number 8400098 — Los Angeles, California, United States
• Investigational Site Number 8400013 — Los Angeles, California, United States
• Investigational Site Number 8400042 — Mission Hills, California, United States
• Investigational Site Number 8400006 — Northridge, California, United States
• Investigational Site Number 8400021 — Orange, California, United States
• Investigational Site Number 8400126 — Rialto, California, United States
• Investigational Site Number 8400094 — Santa Ana, California, United States
• Investigational Site Number 8400009 — Ventura, California, United States
• Investigational Site Number 8400071 — Denver, Colorado, United States
• Investigational Site Number 8400036 — Denver, Colorado, United States
• Investigational Site Number 8400114 — Jacksonville, Florida, United States
• Investigational Site Number 8400133 — Miami, Florida, United States
• Investigational Site Number 8400058 — Port Charlotte, Florida, United States
• Investigational Site Number 8400084 — Tampa, Florida, United States
• Investigational Site Number 8400112 — West Palm Beach, Florida, United States
• Investigational Site Number 8400045 — Lawrenceville, Georgia, United States
• Investigational Site Number 8400096 — Snellville, Georgia, United States
• Investigational Site Number 8400064 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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