Clinical trial NCT03529123: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-05-18
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: From baseline to Week 24
Secondary outcomes:
measure: Patients with HbA1c <7%
timeFrame: At Week 24
measure: Change in 2-hour Post prandial glucose (PPG)
timeFrame: From baseline to Week 24
measure: Change in body weight
timeFrame: From baseline to Week 24
measure: Patients with HbA1c <7% with no body weight gain and no hypoglycemia
timeFrame: At Week 24
measure: Change in Fasting Plasma Glucose
timeFrame: From baseline to Week 24
measure: Adverse events (AE)
timeFrame: Up to 33 weeks
measure: Patients with HbA1c <7% with no body weight gain
timeFrame: At Week 24
measure: Change in SMPG profiles
timeFrame: From baseline to Week 24
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Investigational Site Number 01
city: Belgaum
country: India
facility: Investigational Site Number 012
city: Chennai
country: India
facility: Investigational Site Number 013
city: Coimbatore
country: India
facility: Investigational Site Number 017
city: Hyderabad
country: India
facility: Investigational Site Number 06
city: Hyderabad
country: India
facility: Investigational Site Number 07
city: Jaipur
country: India
facility: Investigational Site Number 08
city: Kolkata
country: India
facility: Investigational Site Number 04
city: Lucknow
country: India
facility: Investigational Site Number 018
city: Madurai
country: India
facility: Investigational Site Number 014
city: Nasik
country: India
facility: Investigational Site Number 05
city: New Delhi
country: India
facility: Investigational Site Number 010
city: Pune
country: India
facility: Investigational Site Number 016
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: