Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010); Drug: Insulin glargine (HOE901); Drug: Metformin

• Registration Number: NCT03798080
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin.

Secondary Objectives:

* To assess the effects of iGlarLixi in comparison with insulin glargine

* To assess the safety in each treatment group

Detailed Description

The maximum study duration per patient will be approximately 33 weeks: an up to 2-week screening period (it can be exceptionally extended up to one additional week), a 30-week, open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin for both treatments), and a 3-day post-treatment safety follow-up period.

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-09
• Study Start: 2019-02-19
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soliqua (insulin glargine/lixisenatide)	Insulin glargine/Lixisenatide (HOE901/AVE0010)	iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks
Soliqua (insulin glargine/lixisenatide)	Metformin	iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks
Lantus (insulin glargine)	Insulin glargine (HOE901)	Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks
Lantus (insulin glargine)	Metformin	Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	From Baseline to Week 30	Change in glycated hemoglobin (HbA1c) from baseline to Week 30

Secondary Outcome Measures

Name	Time	Method
Patients with HbA1c <7.0%	At Week 30	Percentage of patients reaching HbA1c \<7% at Week 30
Patients with HbA1c ≤ 6.5%	At Week 30	Percentage of patients reaching HbA1c ≤ 6.5% at Week 30
Change in postprandial plasma glucose (PPG)	From Baseline to Week 30	Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 30
Change in self-monitored plasma glucose (SMPG) profile	From Baseline to Week 30	Absolute change in 7-point SMPG profiles from baseline to Week 30 (each time point and average daily value)
Patients with HbA1c <7.0% with no body weight gain	At Week 30	Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 30
Change in body weight	From Baseline to Week 30	Absolute change in body weight from baseline to Week 30
Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia	At Week 30	Percentage of patients reaching HbA1c \<7% with no body weight gain at Week 30 and no documented (plasma glucose \[PG\] ≤70 mg/dL \[3.9mmol/L\]) symptomatic hypoglycemia during the 30-week randomized treatment period
Patients requiring rescue therapy	From Baseline to Week 30	Percentage of patients requiring rescue therapy during the 30-week randomized treatment period
Adverse events (AEs)	From Baseline to Week 30	Number of AEs, Serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 30
Immunogenicity (antibody variables)	From Baseline to Week 30	Anti-lixisenatide antibodies (in iGlarLixi group) and anti-insulin antibodies from baseline to Week 30
Change in fasting plasma glucose (FPG)	From Baseline to Week 30	Absolute change in FPG from baseline to Week 30
Confirmed hypoglycemia	From Baseline to Week 30	Severe hypoglycemia and episodes of hypoglycemia documented with PG ≤ 70 mg/dL (3.9mmol/L) regardless of symptoms

Trial Locations

Locations (45)

Investigational Site Number 1560044; 🇨🇳 Baotou, China

Investigational Site Number 1560001; 🇨🇳 Beijing, China

Investigational Site Number 1560039; 🇨🇳 Beijing, China

Investigational Site Number 1560005; 🇨🇳 Changchun, China

Investigational Site Number 1560054; 🇨🇳 Changchun, China

Investigational Site Number 1560015; 🇨🇳 Changsha, China

Investigational Site Number 1560010; 🇨🇳 Chenzhou, China

Investigational Site Number 1560030; 🇨🇳 Chongqing, China

Investigational Site Number 1560025; 🇨🇳 Fuzhou, China

Investigational Site Number 1560016; 🇨🇳 Guangzhou, China

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