None listed
Conditions
Interventions
Group 1 Type of group
2-step initiation regimen of AVE0010: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
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 the end of treatment.
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Patients with type 2 diabetes mellitus, as defined by the QMS (I, Appendix A), diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone. • Written informed consent obtained.
Exclusion criteria
Exclusion criteria: • HbA1c = 10% at screening • At the time of screening age less than the legal age of majority • Women with the potential to conceive without an effective contraceptive method (Women with potential to conceive (pre-menopausal, women not surgically sterilized for at least 3 months before the time of screening) should be confirmed negative to the beta-hCG serum of the pregnancy test at the time of screening, they should use a safe contraceptive method through the study, and agree to repeat the beta-HcG serum pregnancy test at the designated visits). • Diabetes mellitus type 1 • No stable treatment with pioglitazone at a stable dose of at least 30 mg / day at least 3 months before screening. • If the treatment with metformin: it is not at a stable dose of at least 1.5 g / day for at least 3 months before the screening visit. • Plasma fasting glucose at screening> 250 mg / dL (> I3.9 mmol / 1) • Body mass index (BMI) 180 mmHg or> 95 mmHg respectively. • Laboratory findings at the time of screening. -AST, ALT or ALP:> 2 times the upper limit of the normal laboratory ranges. • Any significant clinical abnormality identified in the physical examination, laboratory test, ECG or vital signs at the time of screening that in the opinion of the investigator or any sub-investigator thinks it could impede the safe completion of the study or force the evaluation of efficacy • Patients considered by the investigator or any sub investigator as inappropriate for the study for any reason (eg, failure to meet protocol requirements, such as visiting schedule, inability to self-inject, likely probability of requiring treatment during the screening phase and phase of treatment with drugs not allowed by the protocol of the clinical study, researcher or any sub investigator, pharmacist, study coordinator, or other staff member or relatives directly involved in the conduct of the protocol, etc.) • Use of other oral or injectable antidiabetic agents or hypoglycemic agents other than metformin or pioglitazone (eg sulfonylurea, alpha glucosidase inhibitor, other thiazolidinediones, rimonabant, exenatide, DPP-IV inhibitor, insulin, etc.) within 3 months before the time of screening. • Use of systemic glucocorticoids (excluding topical appli
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 time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 Fasting Plasma Glucose (FPG) at Week 24 Timepoints:Week 24 ; Outcome name:Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 Body Weight at Week 24 Timepoints:Week 24 ; Outcome name:Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. 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 Fasting Plasma Insulin (FPI) at Week 24 Timepoints:Week 24 ; Outcome name:The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of res | — |
Countries
Austria, Canada, France, Germany, Greece, Guatemala, India, Mexico, Peru, Romania, Turkey, United States
Contacts
Public Contactsandra Mendez
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed