EUCTR2008-007334-22-DE
Active, not recruiting
Not Applicable
A randomized, double-blind, double-dummy, 2-arm parallel-group, multicenter 24-week study comparing the efficacy and safety of AVE0010 to sitagliptin as add-on to metformin in obese type 2 diabetic patients younger than 50 and not adequately controlled with metformin.
ConditionsType II DiabetesMedDRA version: 11.1Level: LLTClassification code 10045242Term: <Manually entered code. Term in E.1.1>
DrugsJanuvia®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type II Diabetes
- Sponsor
- Sanofi-Aventis Recherche & Développement
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with type 2 diabetes mellitus, as defined by WHO, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with metformin at a stable dose of at least 1\.5 g/day for at least 3 months prior to the screening visit.
- •2\. Patients with obesity (BMI \= 30kg/m2\) and aged from 18 years to less than 50 years.
- •3\. 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) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Exclusion criteria related to study methodology:
- •1\. HbA1c \< 7\.0% or HbA1c \>10% at screening
- •2\. Type 1 diabetes mellitus
- •3\. Pregnancy or lactation
- •4\. 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 pregnancy test at screening visit.
- •5\. Fasting Plasma Glucose at screening \> 250 mg/dL (\> 13\.9 mmol/L)
- •6\. Weight change of more than 5 kg during the 3 months preceding the screening visit
- •7\. History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g multiple endocrine neoplasia syndromes),
- •8\. History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to
- •9\. Hemoglobinopathy or hemolytic anemia or receipt of blood or plasma products within 3 months prior to the time of screening
Outcomes
Primary Outcomes
Not specified
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