NCT02787551|CompletedPhase 3Results

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

LixiLan-G

A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period

Sanofi ClinicalTrials.gov

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3 other identifiers

EFC137942014-004850-32U1111-1168-4639

Study Type

interventional

Target

514

Locations

8 countries

Sites

120

Timeline

RegisteredJun 2016

StartedJul 2016

CompletionNov 2018

Brief Summary

Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \[SGLT2\] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

514

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes-mellitus

Timeline

Completed

Started Jul 2016

Longer than P75 for phase_3 type-2-diabetes-mellitus

Geographic Reach

8 countries

120 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

May 26, 2016

Completed

6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed

1 month until next milestone

Study Start

First participant enrolled

July 6, 2016

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2018

Completed

7 months until next milestone

Results Posted

Study results publicly available

June 12, 2019

Completed

Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

May 26, 2016

Results QC Date

May 23, 2019

Last Update Submit

March 15, 2022

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.
Baseline, Week 26
Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period
Change in HbA1c was calculated by subtracting baseline value from Week 52 value.
Baseline, Week 52

Secondary Outcomes (16)

Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period
Week 26
Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period
Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period
Baseline, Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period
Baseline, Week 52
Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period
Baseline, Week 26
+11 more secondary outcomes

Study Arms (2)

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)

EXPERIMENTAL

Core period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted. Single arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted.

Drug: Insulin glargine/lixisenatide fixed ratio combinationDrug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)

GLP-1 Receptor Agonist

ACTIVE COMPARATOR

Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily \[BID\], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization.

Drug: liraglutideDrug: exenatideDrug: exenatide extended-releaseDrug: albiglutideDrug: dulaglutideDrug: Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)