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

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

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.

The maximum study duration per patient is 33 weeks.

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.