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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529123
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE May 7, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE June 19, 2018
Actual Primary Completion Date November 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
Change in HbA1c [ Time Frame: From baseline to Week 24 ]
Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
  • Patients with HbA1c <7% [ Time Frame: At Week 24 ]
    Number of patients reaching HbA1c <7 % at the end of Week 24
  • Change in 2-hour Post prandial glucose (PPG) [ Time Frame: From baseline to Week 24 ]
    Change in 2-hour PPG from baseline to Week 24
  • Change in body weight [ Time Frame: From baseline to Week 24 ]
    Change in body weight from baseline to Week 24
  • Patients with HbA1c <7% with no body weight gain and no hypoglycemia [ Time Frame: At Week 24 ]
    Number of patients reaching HbA1c <7% with no body weight gain and no hypoglycemia at the end of Week 24
  • Change in Fasting Plasma Glucose [ Time Frame: From baseline to Week 24 ]
    Mean change in FPG from baseline to Week 24
  • Adverse events (AE) [ Time Frame: Up to 33 weeks ]
    Number of AEs
  • Patients with HbA1c <7% with no body weight gain [ Time Frame: At Week 24 ]
    Number of patients reaching HbA1c <7% with no body weight gain at the end of Week 24
  • Change in SMPG profiles [ Time Frame: From baseline to Week 24 ]
    Change in 7-point self-monitoring plasma glucose (SMPG) profiles 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 Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)
Official Title  ICMJE A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on Basal Insulin With or Without Metformin
Brief Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).

Secondary Objectives:

  • To assess the effects of the FRC in comparison with insulin glargine on:
  • Percentage of patients reaching HbA1c targets (<7% );
  • Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);
  • Body weight
  • Fasting Plasma Glucose (FPG);
  • Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);
  • 7-point Self-Monitoring Plasma Glucose (SMPG) profile;
  • Insulin glargine dose.
  • To assess the safety and tolerability in each treatment group.
Detailed Description The maximum study duration per patient is 33 weeks.
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: Injection

    Route of administration: Subcutaneous

    Other Name: Soliqua, Insulin Glargine/Lixisenatide Fixed Ratio Combination
  • Drug: INSULIN GLARGINE (HOE901)

    Pharmaceutical form: Injection

    Route of administration: Subcutaneous

    Other Name: Lantus®
  • Drug: Metformin

    Pharmaceutical form: Tablet

    Route of administration: Oral

  • Drug: Insulin Glulisine (HMR1964)

    Pharmaceutical form: Injection

    Route of administration: Subcutaneous

    Other Name: Apidra
Study Arms  ICMJE
  • Experimental: Tested Drug
    Insulin glargine/lixisenatide fixed ratio combination (FRC)
    Interventions:
    • Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
    • Drug: Metformin
    • Drug: Insulin Glulisine (HMR1964)
  • Active Comparator: Control Drug
    Insulin glargine (Lantus®)
    Interventions:
    • Drug: INSULIN GLARGINE (HOE901)
    • Drug: Metformin
    • Drug: Insulin Glulisine (HMR1964)
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: November 10, 2020)
247
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2018)
254
Actual Study Completion Date  ICMJE November 25, 2019
Actual Primary Completion Date November 25, 2019   (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,
  • At screening:
  • Age should be ≥ 18 years of age to < 65 years;
  • Glycosylated hemoglobin (HbA1c) at screening visit ≥ 7.5% or ≤ 10%;
  • Body mass index (BMI) ≥ 19 kg/m2 and ≤ 40 kg/m2.
  • Patients who have been treated with a basal insulin for at least 6 months before the screening visit, and who have been on a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. The stable total daily dose should be within the range of 15-40 U, both inclusive, on the day of screening, but individual fluctuations of ± 20% within 2 months prior to screening are acceptable.

Exclusion criteria:

  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening.
  • Previous use of insulin regimen other than basal insulin eg, prandial or pre-mixed insulin (Note: Short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator).
  • For patients taking metformin, any contraindication to metformin use, according to local labeling.
  • For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
  • Average insulin glargine daily dose <20 U or >50 U calculated for the last 3 days before Visit 6.
  • Amylase and/or lipase >3 upper limit normal (ULN) at Visit 5 (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 to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529123
Other Study ID Numbers  ICMJE INSLIL08556
U1111-1200-1162 ( 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 2020

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