Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide FRC to insulin glargine (with or without metformin) over a 30 week treatment period in participants with type 2 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Lixisenatide; Metformin

Criteria

Inclusion criteria :

• Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.

• Treatment with basal insulin for at least 6 months before the screening visit.

• Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.

• Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.

• For participants receiving basal insulin and 1 or 2 oral anti-diabetic drugs (OADs):

the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs could be 1 to 2 out of:

• metformin (more than or equal to 1500 mg/day or maximal tolerated dose),

• a sulfonylurea,

• a glinide,

• a dipeptidyl-peptidase-4 inhibitor,

• a sodium glucose co-transporter 2 inhibitor,

• Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit.

• Signed written informed consent.

Exclusion criteria:

• Age under legal age of adulthood at screening visit.

• HbA1c at screening visit less than 7.5% or above 10%.

• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.

• Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening.

• Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed.

• History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy.

• Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had previously received lixisenatide.

• Use of weight loss drugs within 3 months prior to screening visit.

• Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.

• History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.

• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).

• Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit.

• At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m^2.

• At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.

• At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 3 ULN.

• At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L).

• Any contraindication to metformin use, according to local labeling, if the participant was taking metformin.

• Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin.

Exclusion criteria for randomization:

• HbA1c less than 7% or above 10% .

• Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).

• Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).

• Amylase and/or lipase more than 3 ULN .

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.