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Trial record 2 of 5 for:    lixisenatide | Recruiting, Not yet recruiting, Available Studies

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 (LixiLan-G)

This study is currently recruiting participants.
Verified December 2017 by Sanofi
Sponsor:
ClinicalTrials.gov Identifier:
NCT02787551
First Posted: June 1, 2016
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

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 fixed ratio combination (FRC) to GLP-1 receptor agonist (GLP-1 RA) on top of metformin (with or without pioglitazone, with or without SGLT2 inhibitor) in patients with type 2 diabetes.

To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.


Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: insulin glargine/lixisenatide fixed ratio combination Drug: liraglutide Drug: exenatide Drug: exenatide extended-release Drug: albiglutide Drug: dulaglutide Drug: metformin Drug: pioglitazone Drug: SGLT2 inhibitor Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: Baseline to 26 weeks ]

Secondary Outcome Measures:
  • Percentage of participants reaching HbA1c targets [ Time Frame: Baseline to 26 weeks ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline to 26 weeks ]
  • Change from baseline in 7-point self-monitored plasma glucose (SMPG) profiles [ Time Frame: Baseline to 26 weeks ]
  • Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test [ Time Frame: Baseline to 26 weeks ]
  • Change from baseline in blood glucose excursion during standardized meal test [ Time Frame: Baseline to 26 weeks ]
  • Change from baseline in body weight [ Time Frame: Baseline to 26 weeks ]
  • Percentage of participants with symptomatic hypoglycemia [ Time Frame: 26 weeks ]
  • Number of adverse events [ Time Frame: 26 weeks ]
  • Percentage of patients requiring rescue therapy [ Time Frame: Baseline to 26 weeks ]

Estimated Enrollment: 500
Study Start Date: July 6, 2016
Estimated Study Completion Date: December 24, 2018
Estimated Primary Completion Date: June 27, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin glargine/lixisenatide fixed ratio combination
Insulin glargine/lixisenatide fixed ratio combination (FRC) is injected subcutaneously (SC, under the skin) once daily (QD). Dose individually adjusted. Metformin, pioglitazone (if taken prior to entry in the trial), and SGLT2 inhibitor (if taken prior to entry in the trial) treatments should be continued.
Drug: insulin glargine/lixisenatide fixed ratio combination

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Name: HOE901/AVE0010
Drug: metformin

Pharmaceutical form: tablet

Route of administration: oral

Drug: pioglitazone

Pharmaceutical form: tablet

Route of administration: oral

Drug: SGLT2 inhibitor

Pharmaceutical form: tablet

Route of administration: oral

Active Comparator: Liraglutide/Exenatide/Exenatide ER/Albiglutide/Dulaglutide
Liraglutide will be injected SC (under the skin) QD, and exenatide will be injected SC (under the skin) twice daily (BID). Exenatide extended-release, albiglutide, and dulaglutide are injected SC (under the skin) once weekly. Metformin, pioglitazone (if taken prior to entry in the trial), and SGLT2 inhibitor (if taken prior to entry in the trial) treatments should be continued.
Drug: liraglutide

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Name: Victoza
Drug: exenatide

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Name: Byetta
Drug: exenatide extended-release

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Name: Bydureon
Drug: albiglutide

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Name: Tanzeum
Drug: dulaglutide

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Name: Trulicity
Drug: metformin

Pharmaceutical form: tablet

Route of administration: oral

Drug: pioglitazone

Pharmaceutical form: tablet

Route of administration: oral

Drug: SGLT2 inhibitor

Pharmaceutical form: tablet

Route of administration: oral


Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, with or without SGLT2 inhibitor, all 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, 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 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 <30mL/min/1.73m2 (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:

  • 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-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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787551


Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 129 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02787551     History of Changes
Other Study ID Numbers: EFC13794
2014-004850-32
U1111-1168-4639 ( Other Identifier: UTN )
First Submitted: May 26, 2016
First Posted: June 1, 2016
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Additional relevant MeSH terms:
Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Pioglitazone
Exenatide
Dulaglutide
Insulin
Metformin
Insulin Glargine
Liraglutide
rGLP-1 protein
Glucagon-Like Peptide 1
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors