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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010); Drug: INSULIN GLARGINE (HOE901); Drug: Metformin; Drug: Insulin Glulisine (HMR1964)

• Registration Number: NCT03529123
• Lead Sponsor: Sanofi

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-18
• Study Start: 2018-06-19
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tested Drug	INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)	Insulin glargine/lixisenatide fixed ratio combination (FRC)
Tested Drug	Insulin Glulisine (HMR1964)	Insulin glargine/lixisenatide fixed ratio combination (FRC)
Control Drug	INSULIN GLARGINE (HOE901)	Insulin glargine (Lantus®)
Control Drug	Metformin	Insulin glargine (Lantus®)
Control Drug	Insulin Glulisine (HMR1964)	Insulin glargine (Lantus®)
Tested Drug	Metformin	Insulin glargine/lixisenatide fixed ratio combination (FRC)

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	From baseline to Week 24	Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Change in 2-hour Post prandial glucose (PPG)	From baseline to Week 24	Change in 2-hour PPG from baseline to Week 24
Patients with HbA1c <7%	At Week 24	Number of patients reaching HbA1c \<7 % at the end of Week 24
Change in body weight	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	Number of patients reaching HbA1c \<7% with no body weight gain and no hypoglycemia at the end of Week 24
Change in Fasting Plasma Glucose	From baseline to Week 24	Mean change in FPG from baseline to Week 24
Adverse events (AE)	Up to 33 weeks	Number of AEs
Patients with HbA1c <7% with no body weight gain	At Week 24	Number of patients reaching HbA1c \<7% with no body weight gain at the end of Week 24
Change in SMPG profiles	From baseline to Week 24	Change in 7-point self-monitoring plasma glucose (SMPG) profiles from baseline to Week 24

Trial Locations

Locations (13)

Investigational Site Number 08; 🇮🇳 Jaipur, India

Investigational Site Number 012; 🇮🇳 Belgaum, India

Investigational Site Number 017; 🇮🇳 Coimbatore, India

Investigational Site Number 013; 🇮🇳 Chennai, India

Investigational Site Number 06; 🇮🇳 Hyderabad, India

Investigational Site Number 016; 🇮🇳 Pune, India

Investigational Site Number 014; 🇮🇳 Madurai, India

Investigational Site Number 01; 🇮🇳 Bangalore, India

Investigational Site Number 07; 🇮🇳 Hyderabad, India

Investigational Site Number 018; 🇮🇳 Lucknow, India

Investigational Site Number 04; 🇮🇳 Kolkata, India

Investigational Site Number 05; 🇮🇳 Nasik, India

Investigational Site Number 010; 🇮🇳 New Delhi, India