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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529123
• Other study ID #: INSLIL08556
• Secondary ID: U1111-1200-1162
• Status: Completed
• Phase: Phase 3
• Start date: June 19, 2018
• Est. completion date: November 25, 2019

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The maximum study duration per patient is 33 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
Pharmaceutical form: Injection Route of administration: Subcutaneous
• INSULIN GLARGINE (HOE901)
Pharmaceutical form: Injection Route of administration: Subcutaneous
• Metformin
Pharmaceutical form: Tablet Route of administration: Oral
• Insulin Glulisine (HMR1964)
Pharmaceutical form: Injection Route of administration: Subcutaneous

Locations

Country	Name	City	State
India	Investigational Site Number 01	Bangalore
India	Investigational Site Number 012	Belgaum
India	Investigational Site Number 013	Chennai
India	Investigational Site Number 017	Coimbatore
India	Investigational Site Number 06	Hyderabad
India	Investigational Site Number 07	Hyderabad
India	Investigational Site Number 08	Jaipur
India	Investigational Site Number 04	Kolkata
India	Investigational Site Number 018	Lucknow
India	Investigational Site Number 014	Madurai
India	Investigational Site Number 05	Nasik
India	Investigational Site Number 010	New Delhi
India	Investigational Site Number 016	Pune

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24	From baseline to Week 24
Secondary	Patients with HbA1c <7%	Number of patients reaching HbA1c <7 % at the end of Week 24	At Week 24
Secondary	Change in 2-hour Post prandial glucose (PPG)	Change in 2-hour PPG from baseline to Week 24	From baseline to Week 24
Secondary	Change in body weight	Change in body weight from baseline to Week 24	From baseline to Week 24
Secondary	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	At Week 24
Secondary	Change in Fasting Plasma Glucose	Mean change in FPG from baseline to Week 24	From baseline to Week 24
Secondary	Adverse events (AE)	Number of AEs	Up to 33 weeks
Secondary	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	At Week 24
Secondary	Change in SMPG profiles	Change in 7-point self-monitoring plasma glucose (SMPG) profiles from baseline to Week 24	From baseline to Week 24