Type 2 Diabetes mellitus MedDRA version: 15.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with T2DM diagnosed at least 1 year before the screening visit •Treatment with neutral protamine hagedorn (NPH) or insulin glargine for at least 3 months and at a stable dose (±20%) of at least 10 IU/day (for at least 2 months prior to screening) alone or combined with a stable dose of metformin with without DPP-4 or sulfonylurea •Glycosylated hemoglobin (HbA1c) =6.5 and =9.5% • Body mass index (BMI) between 20 and 40 kg/m2 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: •Pregnant women or breastfeeding women •Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening •Any previous treatment with lixisenatide or participation in a previous study with lixisenatide (AVE0010), and any previous treatment with liraglutide stopped for safety concern or lack of efficacy •Allergic reaction to any GLP-1 agonist in the past (eg, exenatide) or to metacresol •History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease •Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate the effects of repeated subcutaneous doses of lixisenatide 20 µg (once daily) QD as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma glucose (PPG) assessed as area under the plasma glucoseconcentration- time curve (AUC) after a standardized breakfast at the end of a 8- week treatment period in patients with type 2 diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin);Secondary Objective: •To assess the effects of lixisenatide 20 µg QD as compared to liraglutide 1.2 QD or 1.8 mg QD after a 8-week treatment period in patients with T2DM not adequately controlled with insulin glargine (± metformin) on: -Post-prandial C-peptide, glucagon and appetite perceptions after a standardized breakfast -Appetite perceptions after standardized dinner -Gastric emptying after a standardized labelled test meal -Fasting plasma glucose, 24-hour plasma glucose profile -HbA1c -Insulin glargine dose -7-point self monitored plasma glucose (SMPG) -Body weight and waist circumference -24-hour heart rate and blood pressure • To assess lixisenatide and liraglutide safety and tolerability as add on treatment to insulin glargine (± metformin);Primary end point(s): Change from baseline for area under the plasma glucose concentration time profile from time of standardized breakfast start (30 minutes after IMP injection =T0.5) until 4 hours later (T4.5) subtracting the pre-meal plasma glucose value;Timepoint(s) of evaluation of this end point: up to 4h30 after study drug injection on Day-3 and Day 56 (10 timepoints) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline for AUC 0:30-5:30h: area under the glucagon concentration-time curve, from time of standardized breakfast start (30 min after IMP injection=T0.5) until 5 hours later (T5.5) subtracting the pre-meal values Change from baseline for AUC 0:30-5:30h: area under C-peptide concentration time curve, from time of standardized breakfast start (30 min after IMP injection=T0.5) until 5 hours later (T5.5) subtracting the pre-meal values From breath test analysis, change from baseline to Day 55 for gastric emptying coefficient (GEC) Number of patients with 2-hour post-prandial plasma glucose level <140 mg/dL;Timepoint(s) of evaluation of this end point: up to 5h30 after study drug injection on Day-3 and Day 56 (11 timepoints) Day-4 and Day 55 (15 samples per evaluation day) Day-3 and Day 56 | — |
Countries
Germany
Contacts
Public ContactRegulatory Affairs
Sanofi-Aventis Deutschland GmbH
Outcome results
None listed