Research Study Summary
A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin ± Pioglitazone, Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period
The maximum duration for GLP1-RA patients will be approximately 29 weeks: an up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety followup period.
Maximum duration for FRC patients will be approximately 55 weeks: an up to 2- week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period. All primary and secondary efficacy, safety and other endpoints will be also assessed at the end of the extension period
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CW ID: 222885
Date Last Changed:
February 2, 2017
Clinical Trial Snapshot
- Both Male and Female
- 18 and up
- Overall Status
- Facility Type
- Patients with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit.
- Patients who have been treated with one of the following glucagon-like peptide 1 (GLP-1) receptor agonists for at least 4 months prior to screening visit (V1), and with stable dose for at least 3 months prior to screening visit (V1):
- Liraglutide (Victoza®) 1.8 mg QD or 1.2 mg QD, if the 1.8 mg QD dose is not well tolerated according to the Investigator's judgment or
- Exenatide (Byetta®) 10 µg BID or of 5 µg BID, if 10 µg BID dose is not well tolerated according to the Investigator's judgment in combination with metformin (daily dose =1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, both at stable dose for at least 3 months prior to screening.
Patients who have been 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 is not well tolerated according to Investigator's judgment,
- Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW is not well tolerated according to Investigator's judgment in combination with metformin (daily dose =1500 mg/day or MTD), with or without pioglitazone, both at stable dose for at least 3 months prior to screening;
- Signed written informed consent.
- 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 is 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 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.
- Patient who has renal function impairment with estimated glomerular filtration rate <30 mL/min (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 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:
- Patients in the FRC arm with a rescue therapy and HbA1c >8% at week 22.
- Patients in the FRC arm who discontinued prematurely from FRC treatment before week 26.
- Patients in the GLP-1RA treatment arm after randomization.
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