Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

NCT ID: NCT03529123

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2019-11-25

Brief Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).

Secondary Objectives:

• To assess the effects of the FRC in comparison with insulin glargine on:
• Percentage of patients reaching HbA1c targets (<7% );
• Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);
• Body weight
• Fasting Plasma Glucose (FPG);
• Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);
• 7-point Self-Monitoring Plasma Glucose (SMPG) profile;
• Insulin glargine dose.
• To assess the safety and tolerability in each treatment group.

Detailed Description

The maximum study duration per patient is 33 weeks.

Conditions

Type 2 Diabetes Mellitus

Study Design

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

Study Groups

Tested Drug

Insulin glargine/lixisenatide fixed ratio combination (FRC)

Group Type: EXPERIMENTAL

INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)

Intervention Type: DRUG

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Metformin

Intervention Type: DRUG

Pharmaceutical form: Tablet

Route of administration: Oral

Insulin Glulisine (HMR1964)

Intervention Type: DRUG

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Control Drug

Insulin glargine (Lantus®)

Group Type: ACTIVE_COMPARATOR

INSULIN GLARGINE (HOE901)

Intervention Type: DRUG

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Metformin

Intervention Type: DRUG

Pharmaceutical form: Tablet

Route of administration: Oral

Insulin Glulisine (HMR1964)

Intervention Type: DRUG

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Interventions

INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Intervention Type: DRUG

INSULIN GLARGINE (HOE901)

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Intervention Type: DRUG

Metformin

Pharmaceutical form: Tablet

Route of administration: Oral

Intervention Type: DRUG

Insulin Glulisine (HMR1964)

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Intervention Type: DRUG

Other Intervention Names

Soliqua, Insulin Glargine/Lixisenatide Fixed Ratio Combination; Lantus®; Apidra

Eligibility Criteria

Inclusion Criteria

• Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit,
• At screening:
• Age should be ≥ 18 years of age to < 65 years;
• Glycosylated hemoglobin (HbA1c) at screening visit ≥ 7.5% or ≤ 10%;
• Body mass index (BMI) ≥ 19 kg/m2 and ≤ 40 kg/m2.
• Patients who have been treated with a basal insulin for at least 6 months before the screening visit, and who have been on a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. The stable total daily dose should be within the range of 15-40 U, both inclusive, on the day of screening, but individual fluctuations of ± 20% within 2 months prior to screening are acceptable.

• Previous use of insulin regimen other than basal insulin eg, prandial or pre-mixed insulin (Note: Short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator).
• For patients taking metformin, any contraindication to metformin use, according to local labeling.
• For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
• Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.
• History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
• Average insulin glargine daily dose <20 U or >50 U calculated for the last 3 days before Visit 6.
• Amylase and/or lipase >3 upper limit normal (ULN) at Visit 5 (Week -1).

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
• Maximum Eligible Age: 64 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 01

Bangalore, , India

Investigational Site Number 012

Belagavi, , India

Investigational Site Number 013

Chennai, , India

Investigational Site Number 017

Coimbatore, , India

Investigational Site Number 06

Hyderabad, , India

Investigational Site Number 07

Hyderabad, , India

Investigational Site Number 08

Jaipur, , India

Investigational Site Number 04

Kolkata, , India

Investigational Site Number 018

Lucknow, , India

Investigational Site Number 014

Madurai, , India

Investigational Site Number 05

Nashik, , India

Investigational Site Number 010

New Delhi, , India

Investigational Site Number 016

Pune, , India

Countries

India

Other Identifiers

U1111-1200-1162

Identifier Type: OTHER

Identifier Source: secondary_id

INSLIL08556

Identifier Type: -

Identifier Source: org_study_id