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Trial record 16 of 62 for:    Lixisenatide

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

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ClinicalTrials.gov Identifier: NCT03798054
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 9, 2019
Last Update Posted Date November 19, 2019
Actual Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
Change in HbA1c [ Time Frame: From Baseline to Week 24 ]
Change in glycated hemoglobin (HbA1c) from baseline to Week 24
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03798054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • Change in postprandial plasma glucose (PPG) [ Time Frame: From Baseline to Week 24 ]
    Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 24 (for all patients in iGlarLixi or insulin glargine group and patients who receive morning injection in the lixisenatide group)
  • Change in fasting plasma glucose (FPG) [ Time Frame: From Baseline to Week 24 ]
    Absolute change in FPG from baseline to Week 24
  • Change in self-monitored plasma glucose (SMPG) profile [ Time Frame: From Baseline to Week 24 ]
    Absolute change in 7-point SMPG profiles from baseline to Week 24 (each time point and average daily value)
  • Patients with HbA1c <7.0% [ Time Frame: At Week 24 ]
    Percentage of patients reaching HbA1c <7% at Week 24
  • Patients with HbA1c ≤ 6.5% [ Time Frame: At Week 24 ]
    Percentage of patients reaching HbA1c ≤ 6.5% at Week 24
  • Change in body weight [ Time Frame: From Baseline to Week 24 ]
    Absolute change in body weight from baseline to Week 24
  • Patients with HbA1c <7.0% with no body weight gain [ Time Frame: At Week 24 ]
    Percentage of patients reaching HbA1c <7% with no body weight gain at Week 24
  • Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia [ Time Frame: At Week 24 ]
    Percentage of patients reaching HbA1c <7% with no body weight gain at Week 24 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia during the 24 week treatment period
  • Confirmed hypoglycemia [ Time Frame: From Baseline to Week 24 ]
    Including severe hypoglycemia and episodes of hypoglycemia documented with PG ≤70 mg/dL (3.9 mmol/L) regardless of symptoms from baseline to Week 24
  • Adverse events (AEs) [ Time Frame: From Baseline to Week 24 ]
    Number of AEs, serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 24
  • Immunogenicity (antibody variables) [ Time Frame: From Baseline to Week 24 ]
    Anti-lixisenatide antibodies and anti-insulin antibodies (depending on the treatment group) from baseline to Week 24
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 Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
Official Title  ICMJE A Randomized, 24 Week, Active-controlled, Open-label, 3-arm, Parallel-group Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to Insulin Glargine and Lixisenatide in Type 2 Diabetes Mellitus Patients Insufficiently Controlled With Oral Antidiabetic Drug(s)
Brief Summary

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 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.
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 Names:
    • Soliqua
    • iGlarLixi
  • Drug: Insulin glargine (HOE901)

    Pharmaceutical form: solution

    Route of administration: subcutaneous

    Other Name: Lantus
  • Drug: Lixisenatide (AVE0010)

    Pharmaceutical form: solution

    Route of administration: subcutaneous

    Other Name: Lyxumia
  • Drug: Metformin

    Pharmaceutical form: tablet

    Route of administration: oral

Study Arms  ICMJE
  • Experimental: Soliqua (insulin glargine/lixisenatide)
    iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning on top of metformin for 24 weeks.
    Interventions:
    • Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)
    • Drug: Metformin
  • Active Comparator: Lantus (insulin glargine)
    Insulin glargine will be self-administered subcutaneously once daily at any time of the day on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.
    Interventions:
    • Drug: Insulin glargine (HOE901)
    • Drug: Metformin
  • Active Comparator: Lyxumia (lixisenatide)
    Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period.
    Interventions:
    • Drug: Lixisenatide (AVE0010)
    • Drug: Metformin
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2019)
940
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit (V1), treated for at least 3 months prior to the screening visit (V1) with metformin alone or metformin and a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl peptidase-4 (DPP-4) inhibitor or a sodium-glucose co transporter 2 (SGLT-2) inhibitor and who are not adequately controlled with this treatment.
  • Signed written informed consent.

Exclusion criteria:

  • Age < legal age of majority at the screening visit (V1).
  • Body mass index (BMI) >40 kg/m² at screening.
  • Glycated hemoglobin A1c (HbA1c) at screening visit:
  • <7.5% or >11% for patients previously treated with metformin alone;
  • <7.0% or >10% for patients previously treated with metformin and a second oral antidiabetic treatment.
  • History of hypoglycemia unawareness.
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.
  • Previous treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
  • History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reasons or lack of efficacy.
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
  • Use of weight loss drugs within 3 months prior to screening.
  • Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.
  • Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
  • Planned coronary, carotid, or peripheral artery revascularization procedures to be performed during the study period.
  • Known history of drug or alcohol abuse within 6 months prior to screening.
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.
  • Laboratory findings at screening visit (V1):
  • Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
  • Total bilirubin >1.5 ULN (except in case of Gilbert's syndrome).
  • Calcitonin ≥20 pg/mL (5.9 pmol/L).
  • Hemoglobin <10.5 g/dL and/or neutrophils <1500/mm3 and/or platelets <100 000/mm3.
  • Positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (HCAb).
  • Positive urine pregnancy test in female of childbearing potential.
  • Patient who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
  • Use of SU, glinide, alpha-GI, DPP-4 inhibitor, and SGLT-2 inhibitor after start of run-in (from V2 [Week -4]).
  • HbA1c at V4 (Week -1) : <7.0% or >10%.
  • Fasting plasma glucose >250 mg/dL (13.9 mmol/L) at V4 (Week-1) (can be repeated once to confirm).
  • Metformin maximal tolerated dose <1500 mg/day.
  • Amylase and/or lipase >3 ULN at V4 (Week-1).

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 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com
Listed Location Countries  ICMJE China,   Hong Kong,   Korea, Republic of,   Malaysia,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03798054
Other Study ID Numbers  ICMJE EFC14943
U1111-1190-7669 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date November 2019

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