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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)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 1240004
  • Investigational Site Number 1240006
  • Investigational Site Number 1240002
  • Investigational Site Number 1240005
  • Investigational Site Number 1240003
  • Investigational Site Number 1240024
  • Investigational Site Number 1240014
  • Investigational Site Number 1240017
  • Investigational Site Number 1240030
  • Investigational Site Number 1240031
  • Investigational Site Number 1240026
  • Investigational Site Number 1240011
  • Investigational Site Number 1240016
  • Investigational Site Number 1240015
  • Investigational Site Number 1240019
  • Investigational Site Number 1240018
  • Investigational Site Number 1240023
  • Investigational Site Number 1240020
  • Investigational Site Number 1240029
  • Investigational Site Number 1240027
  • Investigational Site Number 1240025
  • Investigational Site Number 1240021
  • Investigational Site Number 1240009
  • Investigational Site Number 1240008
  • Investigational Site Number 1240022
  • Investigational Site Number 1240028
  • Investigational Site Number 1240013
  • Investigational Site Number 1240033
  • Investigational Site Number 1240001
  • Investigational Site Number 1240012
  • Investigational Site Number 1240007
  • Investigational Site Number 1240032

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iGlarlixi DAILY

iGlarlixi WEEKLY

Arm Description

Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached

Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached

Outcomes

Primary Outcome Measures

Change in glycated hemoglobin (HbA1c)%
Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)

Secondary Outcome Measures

Percentage of patients achieving HbA1c ≤7% at Week 26
Percentage of patients achieving A1c ≤7%
Change in fasting plasma glucose (FPG) from baseline to Week 12
Change in FPG from baseline to Week 12
Change in FPG from 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
Change in fasting SMPG from baseline to Week 12
Change in fasting SMPG from baseline to Week 26
Change in fasting SMPG from baseline to Week 26
Change in 7-point SMPG profile from 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
Change in 7-point SMPG profile from baseline to Week 26
Change in body weight from 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
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
Insulin glargine dose (expressed in units)
Percentage of patients requiring rescue therapy
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
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
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
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
Mean number of hypoglycemia episodes (<3.0 mmol/L) per patient year of exposure over 1 year

Full Information

First Posted
December 5, 2018
Last Updated
April 21, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03767543
Brief Title
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)
Acronym
LixilanOne CAN
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iGlarlixi DAILY
Arm Type
Experimental
Arm Description
Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
Arm Title
iGlarlixi WEEKLY
Arm Type
Active Comparator
Arm Description
Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Primary Outcome Measure Information:
Title
Change in glycated hemoglobin (HbA1c)%
Description
Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
Percentage of patients achieving HbA1c ≤7% at Week 26
Description
Percentage of patients achieving A1c ≤7%
Time Frame
At Week 26
Title
Change in fasting plasma glucose (FPG) from baseline to Week 12
Description
Change in FPG from baseline to Week 12
Time Frame
Baseline to Week 12
Title
Change in FPG from baseline to Week 26
Description
Change in FPG from baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in fasting self-monitoring plasma glucose (SMPG) from baseline to Week 12
Description
Change in fasting SMPG from baseline to Week 12
Time Frame
Baseline to Week 12
Title
Change in fasting SMPG from baseline to Week 26
Description
Change in fasting SMPG from baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in 7-point SMPG profile from baseline to Week 12
Description
Change in 7-point SMPG profile from baseline to Week 12
Time Frame
Baseline to Week 12
Title
Change in 7-point SMPG profile from baseline to Week 26
Description
Change in 7-point SMPG profile from baseline to Week 26
Time Frame
Baseline to Week 26
Title
Change in body weight from baseline to Week 26
Description
Change in body weight (kg)
Time Frame
Baseline to Week 26
Title
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
Description
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)
Time Frame
Baseline to Week 26
Title
Insulin glargine dose
Description
Insulin glargine dose (expressed in units)
Time Frame
At Week 26
Title
Percentage of patients requiring rescue therapy
Description
Percentage of patients requiring rescue therapy during the 26-week open-label treatment period
Time Frame
Baseline to Week 26
Title
Percentage of patients experiencing at least 1 hypoglycemia episode (≤3.9 mmol/L) over 26 weeks
Description
Percentage of patients experiencing at least 1 hypoglycemia episode defined as ≤3.9 mmol/L
Time Frame
Baseline to Week 26
Title
Percentage of patients experiencing at least 1 hypoglycemia episode (<3.0 mmol/L) over 26 weeks
Description
Percentage of patients experiencing at least 1 hypoglycemia episode defined as <3.0 mmol/L
Time Frame
Baseline to Week 26
Title
Annualized rate of hypoglycemia (≤3.9 mmol/L) over 26 weeks
Description
Mean number of hypoglycemia episodes (≤3.9 mmol/L) per patient year of exposure over 1 year
Time Frame
Baseline to Week 26
Title
Annualized rate of hypoglycemia (<3.0 mmol/L) over 26 weeks
Description
Mean number of hypoglycemia episodes (<3.0 mmol/L) per patient year of exposure over 1 year
Time Frame
Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 1240004
City
Barrie
ZIP/Postal Code
L4N4L3
Country
Canada
Facility Name
Investigational Site Number 1240006
City
Brampton
ZIP/Postal Code
L6S0C9
Country
Canada
Facility Name
Investigational Site Number 1240002
City
Brampton
ZIP/Postal Code
L6T4V3
Country
Canada
Facility Name
Investigational Site Number 1240005
City
Burlington
ZIP/Postal Code
L7R1A4
Country
Canada
Facility Name
Investigational Site Number 1240003
City
Calgary
ZIP/Postal Code
T2H2G4
Country
Canada
Facility Name
Investigational Site Number 1240024
City
Chicoutimi
ZIP/Postal Code
G7H7K9
Country
Canada
Facility Name
Investigational Site Number 1240014
City
Concord
ZIP/Postal Code
L4K4M2
Country
Canada
Facility Name
Investigational Site Number 1240017
City
Etobicoke
ZIP/Postal Code
M9R4E1
Country
Canada
Facility Name
Investigational Site Number 1240030
City
Greenfield Park
ZIP/Postal Code
J4V2G8
Country
Canada
Facility Name
Investigational Site Number 1240031
City
Halifax
ZIP/Postal Code
B3H1V7
Country
Canada
Facility Name
Investigational Site Number 1240026
City
Hamilton
ZIP/Postal Code
L8S4K1
Country
Canada
Facility Name
Investigational Site Number 1240011
City
Laval
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Investigational Site Number 1240016
City
London
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Investigational Site Number 1240015
City
London
ZIP/Postal Code
N6G 4X8
Country
Canada
Facility Name
Investigational Site Number 1240019
City
Mirabel
ZIP/Postal Code
J7J2K8
Country
Canada
Facility Name
Investigational Site Number 1240018
City
Montreal
ZIP/Postal Code
H1M1B1
Country
Canada
Facility Name
Investigational Site Number 1240023
City
Montreal
ZIP/Postal Code
H4A2C6
Country
Canada
Facility Name
Investigational Site Number 1240020
City
Montreal
ZIP/Postal Code
H4A3T2
Country
Canada
Facility Name
Investigational Site Number 1240029
City
Montreal
ZIP/Postal Code
H4T1Z9
Country
Canada
Facility Name
Investigational Site Number 1240027
City
Nepan
ZIP/Postal Code
K2J0V2
Country
Canada
Facility Name
Investigational Site Number 1240025
City
Newmarket
Country
Canada
Facility Name
Investigational Site Number 1240021
City
Oakville
ZIP/Postal Code
L6M1M1
Country
Canada
Facility Name
Investigational Site Number 1240009
City
Oshawa
ZIP/Postal Code
L1H7K4
Country
Canada
Facility Name
Investigational Site Number 1240008
City
Quebec
ZIP/Postal Code
G1G3Y8
Country
Canada
Facility Name
Investigational Site Number 1240022
City
Quebec
ZIP/Postal Code
G1V4W2
Country
Canada
Facility Name
Investigational Site Number 1240028
City
Saint-Lambert
ZIP/Postal Code
J4P2H4
Country
Canada
Facility Name
Investigational Site Number 1240013
City
St-Marc-des-Carrieres
Country
Canada
Facility Name
Investigational Site Number 1240033
City
Toronto
ZIP/Postal Code
M3J0K2
Country
Canada
Facility Name
Investigational Site Number 1240001
City
Toronto
ZIP/Postal Code
M4G3E8
Country
Canada
Facility Name
Investigational Site Number 1240012
City
Vancouver
ZIP/Postal Code
V5Y3W2
Country
Canada
Facility Name
Investigational Site Number 1240007
City
Victoriaville
ZIP/Postal Code
G6P6P6
Country
Canada
Facility Name
Investigational Site Number 1240032
City
Winnipeg
ZIP/Postal Code
R2V4W3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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://vivli.org
Citations:
PubMed Identifier
35670659
Citation
Hramiak I, Gerstein HC, Leiter LA, Yale JF, Bajaj HS, Stewart J, Toutounji MJ, Harris SB. Comparing a daily versus weekly titration algorithm in people with type 2 diabetes switching from basal insulin to iGlarLixi in the LixiLan ONE CAN randomized trial. Diabetes Obes Metab. 2022 Oct;24(10):1998-2007. doi: 10.1111/dom.14787. Epub 2022 Jun 29.
Results Reference
derived

Learn more about this trial

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)

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