Last updated on October 2020

Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

Brief description of study

Primary Objectives:

The co-primary objective of this study is:

  • To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change.
  • To demonstrate the non-inferiority of iGlarLixi versus insulin glargine on glycemic control as assessed by HbA1c change.

Secondary Objectives:

  • To assess the effects of iGlarLixi in comparison with insulin glargine alone and lixisenatide alone.
  • To assess the safety in each treatment group.

Detailed Study Description

The maximum study duration per patient will be approximately 31 weeks: an up-to 6-week screening and run-in period (with an up-to 2-week screening phase and a 4-week run-in phase), followed by a 24-week randomized treatment period and a 3-day post-treatment safety follow up period.

Clinical Study Identifier: NCT03798054

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Investigational Site Number 4100010

Guri-Si, Gyeonggi-Do, Korea, Republic of
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Investigational Site Number 4100003

Seongnam-Si, Korea, Republic of
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Investigational Site Number 4100014

Uijeongbu-Si, Korea, Republic of
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Recruitment Status: Open

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