None listed
Conditions
Interventions
Group 1 Type of group
2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Group name:Group 2 Type of group
2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with type 2 diabetes mellitus, as defined by CMS (WHO) (I), diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with metformin at a stable dose of at less 1.5 g / day for at least 3 months prior to the selection visit. In addition to metformin, patients may receive sulfonylureas (these should be suspended at visit I) and / or thiazolidinediones (this can be continued). • Obtain informed written consent
Exclusion criteria
Exclusion criteria: • In the age of selection 10% • Pregnancy or breastfeeding • Women with reproductive capacity without effective contraceptive method. • Type 1 diabetes mellitus • Metformin not in a stable dose of at least 1.5 g / day for at least 3 months prior to the selection visit. • Use of oral or injectable or hypoglycemic antidiabetic agents other than metformin, sulfonylurea and thiazolidinediones (eg alpha glucosidase inhibitor, other GLP-1 receptor agonists, DPP-IV inhibitors, insulin etc.) within 3 months prior to At the time of selection, use of medications to lose weight if they are not at a stable dose for at least 3 months prior to the selection visit. • History of ignorance of hypoglycemia. • Body Mass Index (BMI) 180 mmHg or> 110 mmHg, respectively • Patients considered by the investigator or some sub-investigator as inappropriate for this study for any reason (eg, inability to meet the specific requirements of the protocol, such as scheduled visits, who are able to self-inject, who are prone to require treatment during the selection phase and treatment phase with drugs not allowed by the clinical study protocol, that the patient is the researcher or some sub-researcher, pharmacist, study coordinator, other study staff or relative from this directly involved in the protocol conduction, etc). • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for a week or more within 3 months prior to the time of selection • Use of any investigational medication within 3 months prior to selection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. Measure:Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 Timepoints:Baseline, Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. Measure:Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24 Timepoints:Baseline, Week 24 ; Outcome name:Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. Measure:Change From Baseline in Glucose Excursion at Week 24 Timepoints:Baseline, Week 24 ; Outcome name:Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required. Measure:Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) P | — |
Countries
Denmark, Estonia, France, Germany, Greece, Hungaria, Italy, Netherlands, Poland, Sweden
Contacts
Public ContactShellah Albites
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed