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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)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
INSULIN GLARGINE (HOE901)
Metformin
Insulin Glulisine (HMR1964)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 01
  • Investigational Site Number 012
  • Investigational Site Number 013
  • Investigational Site Number 017
  • Investigational Site Number 06
  • Investigational Site Number 07
  • Investigational Site Number 08
  • Investigational Site Number 04
  • Investigational Site Number 018
  • Investigational Site Number 014
  • Investigational Site Number 05
  • Investigational Site Number 010
  • Investigational Site Number 016

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tested Drug

Control Drug

Arm Description

Insulin glargine/lixisenatide fixed ratio combination (FRC)

Insulin glargine (Lantus®)

Outcomes

Primary Outcome Measures

Change in HbA1c
Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24

Secondary Outcome Measures

Patients with HbA1c <7%
Number of patients reaching HbA1c <7 % at the end of Week 24
Change in 2-hour Post prandial glucose (PPG)
Change in 2-hour PPG from baseline to Week 24
Change in body weight
Change in body weight from baseline to Week 24
Patients with HbA1c <7% with no body weight gain and no hypoglycemia
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
Mean change in FPG from baseline to Week 24
Adverse events (AE)
Number of AEs
Patients with HbA1c <7% with no body weight gain
Number of patients reaching HbA1c <7% with no body weight gain at the end of Week 24
Change in SMPG profiles
Change in 7-point self-monitoring plasma glucose (SMPG) profiles from baseline to Week 24

Full Information

First Posted
May 7, 2018
Last Updated
April 21, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03529123
Brief Title
Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tested Drug
Arm Type
Experimental
Arm Description
Insulin glargine/lixisenatide fixed ratio combination (FRC)
Arm Title
Control Drug
Arm Type
Active Comparator
Arm Description
Insulin glargine (Lantus®)
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
Other Intervention Name(s)
Soliqua, Insulin Glargine/Lixisenatide Fixed Ratio Combination
Intervention Description
Pharmaceutical form: Injection Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE (HOE901)
Other Intervention Name(s)
Lantus®
Intervention Description
Pharmaceutical form: Injection Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Pharmaceutical form: Tablet Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Insulin Glulisine (HMR1964)
Other Intervention Name(s)
Apidra
Intervention Description
Pharmaceutical form: Injection Route of administration: Subcutaneous
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24
Time Frame
From baseline to Week 24
Secondary Outcome Measure Information:
Title
Patients with HbA1c <7%
Description
Number of patients reaching HbA1c <7 % at the end of Week 24
Time Frame
At Week 24
Title
Change in 2-hour Post prandial glucose (PPG)
Description
Change in 2-hour PPG from baseline to Week 24
Time Frame
From baseline to Week 24
Title
Change in body weight
Description
Change in body weight from baseline to Week 24
Time Frame
From baseline to Week 24
Title
Patients with HbA1c <7% with no body weight gain and no hypoglycemia
Description
Number of patients reaching HbA1c <7% with no body weight gain and no hypoglycemia at the end of Week 24
Time Frame
At Week 24
Title
Change in Fasting Plasma Glucose
Description
Mean change in FPG from baseline to Week 24
Time Frame
From baseline to Week 24
Title
Adverse events (AE)
Description
Number of AEs
Time Frame
Up to 33 weeks
Title
Patients with HbA1c <7% with no body weight gain
Description
Number of patients reaching HbA1c <7% with no body weight gain at the end of Week 24
Time Frame
At Week 24
Title
Change in SMPG profiles
Description
Change in 7-point self-monitoring plasma glucose (SMPG) profiles from baseline to Week 24
Time Frame
From baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 01
City
Bangalore
ZIP/Postal Code
560092
Country
India
Facility Name
Investigational Site Number 012
City
Belgaum
ZIP/Postal Code
590010
Country
India
Facility Name
Investigational Site Number 013
City
Chennai
ZIP/Postal Code
600086
Country
India
Facility Name
Investigational Site Number 017
City
Coimbatore
ZIP/Postal Code
641009
Country
India
Facility Name
Investigational Site Number 06
City
Hyderabad
ZIP/Postal Code
500063
Country
India
Facility Name
Investigational Site Number 07
City
Hyderabad
ZIP/Postal Code
500072
Country
India
Facility Name
Investigational Site Number 08
City
Jaipur
Country
India
Facility Name
Investigational Site Number 04
City
Kolkata
ZIP/Postal Code
700107
Country
India
Facility Name
Investigational Site Number 018
City
Lucknow
Country
India
Facility Name
Investigational Site Number 014
City
Madurai
ZIP/Postal Code
625020
Country
India
Facility Name
Investigational Site Number 05
City
Nasik
ZIP/Postal Code
422002
Country
India
Facility Name
Investigational Site Number 010
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Investigational Site Number 016
City
Pune
ZIP/Postal Code
411040
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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://vivli.org

Learn more about this trial

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

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