Clinical Trial Details

Overview

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

Purpose
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

To Learn more

CW ID: 222885
Date Last Changed: February 2, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Sanofi
Facility Type
N/A

Eligibility

Inclusion criteria:
  • 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. or 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.
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 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.

Contact

John-Paul Suastegui
University of South Florida - Morsani Center for Advanced Healthcare
13330 USF Laurel Dr
Tampa, FL 33612
Phone: (813) 974-1440

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