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

NCT03529123 | Completed Phase 3

• 2 other identifiers: INSLIL08556U1111-1200-1162
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 13

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24

  From baseline to Week 24

Secondary Outcomes (8)

• Patients with HbA1c <7%

  At Week 24

• Change in 2-hour Post prandial glucose (PPG)

  From baseline to Week 24

• Change in body weight

  From baseline to Week 24

• Patients with HbA1c <7% with no body weight gain and no hypoglycemia

  At Week 24

• Change in Fasting Plasma Glucose

  From baseline to Week 24

Study Arms (2)

Tested Drug

EXPERIMENTAL

Insulin glargine/lixisenatide fixed ratio combination (FRC)

Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010); Drug: Metformin; Drug: Insulin Glulisine (HMR1964)

Control Drug

ACTIVE COMPARATOR

Insulin glargine (Lantus®)

Drug: INSULIN GLARGINE (HOE901); Drug: Metformin; Drug: Insulin Glulisine (HMR1964)

Interventions

INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010) DRUG

Pharmaceutical form: Injection Route of administration: Subcutaneous

Also known as: Soliqua, Insulin Glargine/Lixisenatide Fixed Ratio Combination

Tested Drug

INSULIN GLARGINE (HOE901) DRUG

Pharmaceutical form: Injection Route of administration: Subcutaneous

Also known as: Lantus®

Control Drug

Metformin DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Control Drug; Tested Drug

Insulin Glulisine (HMR1964) DRUG

Pharmaceutical form: Injection Route of administration: Subcutaneous

Also known as: Apidra

Control Drug; Tested Drug

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (13)

Investigational Site Number 01

Bangalore, 560092, India

Location

Investigational Site Number 012

Belagavi, 590010, India

Location

Investigational Site Number 013

Chennai, 600086, India

Location

Investigational Site Number 017

Coimbatore, 641009, India

Location

Investigational Site Number 06

Hyderabad, 500063, India

Location

Investigational Site Number 07

Hyderabad, 500072, India

Location

Investigational Site Number 08

Jaipur, India

Location

Investigational Site Number 04

Kolkata, 700107, India

Location

Investigational Site Number 018

Lucknow, India

Location

Investigational Site Number 014

Madurai, 625020, India

Location

Investigational Site Number 05

Nashik, 422002, India

Location

Investigational Site Number 010

New Delhi, 110029, India

Location

Investigational Site Number 016

Pune, 411040, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide; Metformin; insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Study Start: June 19, 2018
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (13)