Type 2 Diabetes Mellitus MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: Insulin glargine and lixisenatide in fixed ratio combination
Product Code: HOE901/AVE0010
Pharmaceutical Form: Solution for injection in pre-filled pen
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit. -Patients who have been treated with one of the following glucagon-like peptide 1 (GLP-1) receptor agonists for at least 4 months prior to screening visit (V1), and with stable dose for at least 3 months prior to screening visit (V1): -Liraglutide (Victoza®) 1.8 mg QD or 1.2 mg QD, if the 1.8 mg QD dose is not well tolerated according to the Investigator's judgment or -Exenatide (Byetta®) 10 µg BID or of 5 µg BID, if 10 µg BID dose is not well tolerated according to the Investigator's judgment in combination with metformin (daily dose =1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening. or Patients who have been treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1): -Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator’s judgment, -Albiglutide (Tanzeum®) 50 mg QW or 30 mg QW, if 50 mg QW is not well tolerated according to Investigator’s judgment, -Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW is not well tolerated according to Investigator’s judgment in combination with metformin (daily dose =1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening; -Signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 616 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 154
Exclusion criteria
Exclusion criteria: -At screening visit, age 9%. -Pregnancy or lactation, women of childbearing potential with no effective contraceptive method. -Any use of antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria. -Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin [=10 days] due to intercurrent illness including gestational diabetes is allowed at the discretion of the study physician). -Laboratory findings at the time of screening, including: -Fasting plasma glucose (FPG) >250 mg/dL (13.9 mmol/L), -Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN), -Alanine transaminase or aspartate transaminase >3 ULN, -Calcitonin =20 pg/mL (5.9 pmol/L), -Positive pregnancy test. -Patient who has renal function impairment with estimated glomerular filtration rate 40 kg/m^2. Exclusion criteria for the extension period: -Patients in the FRC arm with a rescue therapy and HbA1c >8% at week 22. -Patients in the FRC arm who discontinued prematurely from FRC treatment before week 26. -Patients in the GLP-1RA treatment arm after randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.; Secondary Objective: To compare the overall efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination (FRC) to GLP-1 receptor agonist (GLP-1 RA) on top of metformin (with or without pioglitazone, with or without SGLT2 inhibitor) in patients with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period. ;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: Baseline to 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Percentage of participants reaching HbA1c targets 2- Change from baseline in FPG 3- Change from baseline in 7-point self-monitored plasma glucose (SMPG) profiles 4- Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test 5- Change from baseline in blood glucose excursion during standardized meal test 6- Percentage of patients requiring rescue therapy 7- Change from baseline in body weight 8- Percentage of participants with symptomatic hypoglycemia 9- Number of adverse events ; Timepoint(s) of evaluation of this end point: 1-2-3-4-5-6-7 Baseline to 26 weeks 8-9 26 weeks | — |
Countries
Canada, Estonia, Germany, Israel, Italy, Romania, Slovakia, Spain, United States
Contacts
Public Contactwww.sanofi.cz
sanofi-aventis, s.r.o.
Outcome results
None listed