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)

NCT ID: NCT03767543

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2020-10-23

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iGlarlixi DAILY

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

Group Type: EXPERIMENTAL

INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010

Intervention Type: DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

iGlarlixi WEEKLY

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

Group Type: ACTIVE_COMPARATOR

INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010

Intervention Type: DRUG

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Interventions

INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 1240004

Barrie, , Canada

Investigational Site Number 1240006

Brampton, , Canada

Investigational Site Number 1240002

Brampton, , Canada

Investigational Site Number 1240005

Burlington, , Canada

Investigational Site Number 1240003

Calgary, , Canada

Investigational Site Number 1240024

Chicoutimi, , Canada

Investigational Site Number 1240014

Concord, , Canada

Investigational Site Number 1240017

Etobicoke, , Canada

Investigational Site Number 1240030

Greenfield Park, , Canada

Investigational Site Number 1240031

Halifax, , Canada

Investigational Site Number 1240026

Hamilton, , Canada

Investigational Site Number 1240011

Laval, , Canada

Investigational Site Number 1240016

London, , Canada

Investigational Site Number 1240015

London, , Canada

Investigational Site Number 1240019

Mirabel, , Canada

Investigational Site Number 1240018

Montreal, , Canada

Investigational Site Number 1240023

Montreal, , Canada

Investigational Site Number 1240020

Montreal, , Canada

Investigational Site Number 1240029

Montreal, , Canada

Investigational Site Number 1240027

Nepan, , Canada

Investigational Site Number 1240025

Newmarket, , Canada

Investigational Site Number 1240021

Oakville, , Canada

Investigational Site Number 1240009

Oshawa, , Canada

Investigational Site Number 1240008

Québec, , Canada

Investigational Site Number 1240022

Québec, , Canada

Investigational Site Number 1240028

Saint-Lambert, , Canada

Investigational Site Number 1240013

Saint-Marc-des-Carrieres, , Canada

Investigational Site Number 1240033

Toronto, , Canada

Investigational Site Number 1240001

Toronto, , Canada

Investigational Site Number 1240012

Vancouver, , Canada

Investigational Site Number 1240007

Victoriaville, , Canada

Investigational Site Number 1240032

Winnipeg, , Canada

Countries

Canada

References

Yale JF, Roborel de Climens A, Aggarwal N, Dex T, Gerstein HC, Harris S, Hramiak I, Stewart J, Leiter LA. Ease of Use of the iGlarLixi SoloStar Pen from the LixiLan ONE CAN Pen Sub-Study: Questionnaire Findings from People Living with Type 2 Diabetes and Their HealthCare Providers. Diabetes Ther. 2023 Feb;14(2):377-386. doi: 10.1007/s13300-022-01353-6. Epub 2022 Dec 27.

Reference Type: DERIVED

PMID: 36574199 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35670659 (View on PubMed)

Other Identifiers

U1111-1215-0238

Identifier Type: OTHER

Identifier Source: secondary_id

LPS15544

Identifier Type: -

Identifier Source: org_study_id