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Trial record 30 of 63 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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03767543
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE December 5, 2018
First Posted Date  ICMJE December 6, 2018
Last Update Posted Date April 20, 2020
Actual Study Start Date  ICMJE March 11, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Percentage of patients achieving HbA1c ≤7% at Week 26 [ Time Frame: At Week 26 ]
    Percentage of patients achieving A1c ≤7%
  • 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
  • Change in FPG from baseline to Week 26 [ Time Frame: Baseline to Week 26 ]
    Change in FPG from baseline to Week 26
  • 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
  • Change in fasting SMPG from baseline to Week 26 [ Time Frame: Baseline to Week 26 ]
    Change in fasting SMPG from baseline to Week 26
  • 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
  • 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
  • Change in body weight from baseline to Week 26 [ Time Frame: Baseline to Week 26 ]
    Change in body weight (kg)
  • 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)
  • Insulin glargine dose [ Time Frame: At Week 26 ]
    Insulin glargine dose (expressed in units)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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).

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Study Arms  ICMJE
  • Experimental: iGlarlixi DAILY
    Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
    Intervention: Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
  • Active Comparator: iGlarlixi WEEKLY
    Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
    Intervention: Drug: INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
264
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03767543
Other Study ID Numbers  ICMJE LPS15544
U1111-1215-0238 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP