Clinical Trial Details

Overview

Research Study Summary

LixiLan-G EFC13794

Purpose

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.

To Learn more

CW ID: 220607
Date Last Changed: November 7, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Sanofi US
Duration
26 Weeks
Facility Type
N/A

Eligibility

Key Inclusion Criteria:

  • 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;

Key Exclusion: 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;

Contact

Denise Esparza, Sr. CRC
Diabetes Associates Medical Group / Clinical Research
1234 W. Chapman Ave., Suite 106
Orange, CA 92868
Phone: 714-202-8894
Fax: 714-639-3904

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