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

Conditions

• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Insulin glargine/lixisenatide fixed ratio combination — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous
• liraglutide — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous
• exenatide — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous
• exenatide extended-release — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous
• albiglutide — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous
• dulaglutide — DRUG
  Pharmaceutical form: solution for injection Route of administration: subcutaneous
• Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor) — DRUG
  Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.

Study Details

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.

Key Dates

Start date

Jul 6, 2016

Status verified

Mar 2022

Primary completion

May 25, 2018

Completion

Nov 17, 2018

Study Design

Enrollment

514 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)
  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.
• Active Comparator: GLP-1 Receptor Agonist
  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.

Primary Outcome Measure

Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period [ Time Frame: Baseline, Week 26 ]

Locations (74)

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