LixiLan-G EFC13794

  • STATUS
    Recruiting
  • sponsor
    Sanofi US
Updated on 8 November 2020

Summary

LixiLan-G EFC13794

Description

A 26-week open-label 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 ± pioglitazone.

Details
Clinical Study IdentifierTX146000
SponsorSanofi US
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Patients with type 2 diabetes mellitus diagnosed at least one year prior to screening visit
Patients who have been treated with one of the following GLP-1 receptor agonists for at least 4 months prior to screening visit (V1), and with stable dose for at least 3 months prior to screening visit (V1)
Liraglutide (Victoza®) 1.8 mg QD or 1.2 mg QD, if 1.8 mg QD is not well tolerated according to Investigator's judgment
or Exenatide BID (Byetta®) 10 µg BID or of 5 µg BID, if 10 µg BID is not well tolerated according to Investigator's judgment; in combination with metformin (daily dose =1500 mg/day or Maximum Tolerated Dose [MTD]), with or without pioglitazone, both at stable dose for at least 3 months prior to screening; or Patients who have been treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1)
Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator's judgment
Albiglutide (Tanzeum®, Eperzan®) 50 mg QW or 30 mg QW, if 50 mg QW is not well tolerated according to Investigator's judgment
Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW is not well tolerated according to Investigator's judgment in combination with metformin (daily dose =1500 mg/day or MTD), with or without pioglitazone, both at stable dose for at least 3 months prior to screening

Exclusion Criteria

EXCLUSION CRITERIA
At screening visit, age under legal age of adulthood
At screening visit, HbA1c <7% (53 mmol/mol) and >9% (75 mmol/mol)
Use of weight loss drugs within 3 months prior to screening visit; or any history of bariatric surgery
Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening visit
Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization
Known history of drug or alcohol abuse within 6 months prior to the time of screening visit
Pregnant or breastfeeding woman; Woman of childbearing potential not protected by highly-effective method(s) of birth control, unwilling or unable to be tested for pregnancy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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