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Trial record 18 of 61 for:    Lixisenatide

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan (LIXILAN JP-O1)

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ClinicalTrials.gov Identifier: NCT02749890
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE April 20, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date July 11, 2018
Actual Study Start Date  ICMJE May 9, 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2016)
Change from baseline in HbA1c [ Time Frame: Baseline, 26 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02749890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2016)
  • Percentage of patients reaching HbA1c <7% or ≤6.5% [ Time Frame: 26 weeks ]
  • Change from baseline in fasting plasma glucose [ Time Frame: Baseline, 26 weeks ]
  • Change in from baseline in 7 point self-monitored plasma profiles [ Time Frame: Baseline, 26 weeks ]
  • Percentage of patients reaching HbA1c <7% with no body weight gain [ Time Frame: 26 weeks ]
  • Change from baseline in body weight [ Time Frame: Baseline, 26 weeks ]
  • Percentage of patients requiring a rescue therapy [ Time Frame: 26 weeks ]
  • Change in daily dose of insulin glargine for the combination group [ Time Frame: Day 1, 26 weeks ]
  • Number of hypoglycemic events [ Time Frame: 26 weeks, 52 weeks ]
  • Number of adverse events [ Time Frame: 26 weeks, 52 weeks ]
  • Measurement of anti-lixisenatide antibodies from baseline [ Time Frame: Baseline, 26 weeks, 52 weeks ]
  • Measurement of anti-insulin antibodies from baseline [ Time Frame: Baseline, 26 weeks, 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan
Official Title  ICMJE A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period
Brief Summary

Primary Objective:

To compare LixiLan to lixisenatide in glycated hemoglobin (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus.

Secondary Objective:

To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.

Detailed Description Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)

    Pharmaceutical form: solution

    Route of administration: subcutaneous

    Other Name: LixiLan
  • Drug: Lixisenatide (AVE0010)

    Pharmaceutical form: solution

    Route of administration: subcutaneous

  • Drug: Oral anti-diabetic drugs

    Pharmaceutical form: tablet

    Route of administration: Oral

Study Arms  ICMJE
  • Experimental: LixiLan

    LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted.

    Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.

    Interventions:
    • Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)
    • Drug: Oral anti-diabetic drugs
  • Active Comparator: lixisenatide

    Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period.

    Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.

    Interventions:
    • Drug: Lixisenatide (AVE0010)
    • Drug: Oral anti-diabetic drugs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2018)
321
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2016)
318
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be biguanide, thiazolidinedione, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor.
  • Signed written informed consent.

Exclusion criteria:

  • At the screening visit: age <20 years.
  • At the screening visit: HbA1c <7.5% or >10%.
  • At the screening visit: fasting plasma glucose (FPG) >250 mg/dL (13.8 mmol/L).
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria during the 3 months before the screening visit.
  • Previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician).
  • Laboratory findings at the screening visit, including:
  • Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN,
  • Calcitonin ≥20 pg/mL (5.9 pmol/L),
  • Positive serum pregnancy test.
  • Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any glucagon-like peptide-1 receptor agonist (GLP-1RA) or to metacresol.
  • Contraindication to use of insulin glargine according to the local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.
  • Patient who has a severe renal function impairment with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m^2 or end-stage renal disease for patient not treated with metformin.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02749890
Other Study ID Numbers  ICMJE EFC14112
U1111-1176-8357 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP