EUCTR2007-005884-92-AT
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 on top of pioglitazone in patients with type 2 diabetes not adequately controlled with pioglitazone. - GETGOAL-P
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type II diabetes
- Sponsor
- Sanofi-Aventis Recherche & Développement
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with type 2 diabetes mellitus, as defined by WHO (Fasting plasma glucose \=7 mmol/L (126 mg/dL) or 2 hours postprandial plasma glucose \=11\.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with pioglitazone.
- •Written informed consent obtained.
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Related to study methodo
- •\- HbA1c \<7\.0 % or HbA1c \>10 % at screening.
- •\- At the time of screening age \- Women of childbearing potential with no effective contraceptive method (Women of childbearing potential (pre\-menopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative serum ß\-hCG pregnancy test at screening visit. They must use an effective contraceptive method throughout the study, and agree to repeat serum ß\-hCG pregnancy test at designated visits).
- •\- Type 1 diabetes mellitus.
- •\- No stable treatment with pioglitazone at a stable dose of at least 30 mg/day for at least 3 months prior to screening.
- •\- If treatment with metformin: no stable dose of at least 1\.5 g/day for at least 3 months prior to screening visit.
- •\- Fasting Plasma Glucose at screening \>250 mg/dL (\>13\.9 mmol/l).
- •\- Body Mass Index \=20 kg/m².
- •\- Weight change of more than 5 kg during the 3 months preceding the screening visit.
- •\- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
Outcomes
Primary Outcomes
Not specified
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