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Trial record 34 of 61 for:    Lixisenatide

Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM) (LixilanOne CAN)

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ClinicalTrials.gov Identifier: NCT03767543
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling.

Secondary Objective:

To gain additional information on the efficacy and safety of using a simple patient-titration protocol for administration of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi).


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 Phase 3

Detailed Description:
The maximum duration of study per patient is approximately 29 weeks including a 2-week screening, a 26-week randomized active-controlled treatment period, and 3-day post-treatment safety follow-up period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, 26-week, Open-label, 2-treatment Arm, Parallel Group Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated Using a Simple Titration Algorithm (One Unit Daily Adjustment) Compared With Insulin Glargine/Lixisenatide Fixed-ratio Combination (Soliqua™) Titrated by Weekly Adjustment in Patients With Type 2 Diabetes Mellitus (T2DM)
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: iGlarlixi DAILY
Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Active Comparator: iGlarlixi WEEKLY
Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous




Primary Outcome Measures :
  1. Change in glycated hemoglobin (HbA1c)% [ Time Frame: Baseline to Week 26 ]
    Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)


Secondary Outcome Measures :
  1. Percentage of patients achieving HbA1c ≤7% at Week 26 [ Time Frame: At Week 26 ]
    Percentage of patients achieving A1c ≤7%

  2. Change in fasting plasma glucose (FPG) from baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
    Change in FPG from baseline to Week 12

  3. Change in FPG from baseline to Week 26 [ Time Frame: Baseline to Week 26 ]
    Change in FPG from baseline to Week 26

  4. Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
    Change in fasting SMPG from baseline to Week 12

  5. Change in fasting SMPG from baseline to Week 26 [ Time Frame: Baseline to Week 26 ]
    Change in fasting SMPG from baseline to Week 26

  6. Change in 7-point SMPG profile from baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
    Change in 7-point SMPG profile from baseline to Week 12

  7. Change in 7-point SMPG profile from baseline to Week 26 [ Time Frame: Baseline to Week 26 ]
    Change in 7-point SMPG profile from baseline to Week 26

  8. Change in body weight from baseline to Week 26 [ Time Frame: Baseline to Week 26 ]
    Change in body weight (kg)

  9. Percentage of patients achieving A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L) at Week 26 [ Time Frame: Baseline to Week 26 ]
    Composite endpoint expressed as percentage of patients A1c ≤7% with no body weight gain and/or hypoglycemia (severe or documented symptomatic (≤3.9 mmol/L)

  10. Insulin glargine dose [ Time Frame: At Week 26 ]
    Insulin glargine dose (expressed in units)

  11. Percentage of patients requiring rescue therapy [ Time Frame: Baseline to Week 26 ]
    Percentage of patients requiring rescue therapy during the 26-week open-label treatment period

  12. Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks [ Time Frame: Baseline to Week 26 ]
    Percentage of patients experiencing at least 1 hypoglycemia episode defined as ≤3.9 mmol/L

  13. Percentage of patients experiencing at least 1 hypoglycemia episode (<3.0 mmol/L) over 26 weeks [ Time Frame: Baseline to Week 26 ]
    Percentage of patients experiencing at least 1 hypoglycemia episode defined as <3.0 mmol/L

  14. Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks [ Time Frame: Baseline to Week 26 ]
    Mean number of hypoglycemia episodes (≤3.9 mmol/L) per patient year of exposure over 1 year

  15. Annualized rate of hypoglycemia (<3.0 mmol/L) over 26 weeks [ Time Frame: Baseline to Week 26 ]
    Mean number of hypoglycemia episodes (<3.0 mmol/L) per patient year of exposure over 1 year



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

Inclusion criteria:

  • Adult subject ≥ 18 years
  • Patients with type 2 diabetes mellitus (T2DM) based on Diabetes Canada 2018 Clinical Practice Guidelines criteria and diagnosed at least 6 months prior to the screening visit
  • Uncontrolled glycemia with an A1c ≥7.5% and ≤10.5%
  • Patients treated for at least 6 months on any basal insulin (including but not limited to insulin glargine, Toujeo®, Degludec®, etc.) ± oral anti-diabetic drug (OADs)
  • The total basal insulin dose must be ≤ 40 units/day
  • The OADs allowed at inclusion are metformin, insulin secretagogues, dipeptidyl-peptidase-4 inhibitors (DPP4) inhibitors and SGLT2 inhibitors; with no change in OAD dose for at least 2 months prior to randomization
  • Body mass index (BMI) between 20 kg/m2 and 40 kg/m2 inclusively

Exclusion criteria:

  • History of severe hypoglycemia or hypoglycemia unawareness
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening visit
  • Current or previous (known intolerance to GLP-1s) treatment with glucagon like peptide-1 (GLP-1) receptor agonist
  • Current use of rapid-acting insulin or premix insulins or use of these insulins within 3 months prior to the screening visit
  • Use of systemic glucocorticoids (excluding topical and inhaled forms) for a total duration of 1 week or more within 3 months prior to the screening visit
  • Use of weight loss drugs within 3 months prior to the screening visit
  • Patients with conditions/concomitant diseases that will affect safe participation in this study (e.g. active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require treatment within the study period, etc.)
  • Women of childbearing potential (WOCBP) not protected by an effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
  • Positive serum pregnancy test in WOCBP, pregnancy or lactation
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) or uncontrolled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening visit
  • History of pancreatitis (unless pancreatitis was related to gallstones and treated with cholecystectomy), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, or stomach/gastric surgery
  • Personal or immediate family history of medullary thyroid cancer or genetic conditions that predispose the patient to medullary thyroid cancer (e.g. multiple endocrine neoplasia syndromes)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT03767543


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
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Canada
Investigational Site Number 1240002 Recruiting
Brampton, Canada, L6T4V3
Investigational Site Number 1240017 Recruiting
Etobicoke, Canada, M9R4E1
Investigational Site Number 1240020 Recruiting
Montreal, Canada, H4A3T2
Investigational Site Number 1240027 Recruiting
Nepan, Canada, K2J0V2
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03767543     History of Changes
Other Study ID Numbers: LPS15544
U1111-1215-0238 ( Other Identifier: UTN )
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs