PER-069-09
Completed
未知
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
sanofi-aventis Recherche & Development,0 sites0 target enrollmentNovember 11, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- sanofi-aventis Recherche & Development,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Patients with obesity (BMI \= 30kg/m2\) and aged from 18 years to less than 50 years.
- •Written informed consent obtained
Exclusion Criteria
- •HbA1c \< 7\.0% or HbA1c \>10% at screening
- •Type 1 diabetes mellitus
- •Pregnancy or lactation
- •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.
- •Fasting Plasma Glucose at screening \> 250 mg/dL (\> 13\.9 mmol/L)
- •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, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g multiple endocrine neoplasia syndromes),
- •History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
- •Hemoglobinopathy or hemolytic anemia or receipt of blood or plasma products within 3 months prior to the time of screening
- •Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
Outcomes
Primary Outcomes
Not specified
Similar Trials
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.Type II DiabetesMedDRA version: 11.1Level: LLTClassification code 10045242Term: <Manually entered code. Term in E.1.1>EUCTR2008-007334-22-DESanofi-Aventis Recherche & Développement300
Completed
Phase 3
A clinical trial to study the effects of two drugs, Dynapar QPS and placebo topical solution in patient suffering from osteoarthritis.Health Condition 1: null- Osteoarthritis of kneeCTRI/2015/02/005510Troikaa Pharmaceuticals Limited212
Completed
Phase 2
To evaluate efficacy, safety and tolerability of two dose strengths of tacrolimus lipid suspension for injection rectally administered in adult patients with ulcerative colitisHealth Condition 1: K519- Ulcerative colitis, unspecifiedCTRI/2015/10/006252Intas Pharmaceuticals Ltd60
Completed
Not Applicable
A study to evaluate the safety and efficacy of a test product in female subjects with varied skin type.CTRI/2023/10/059282DPKA Universal Consumer Ventures Private Limited96
Completed
Phase 3
Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically IllHealth Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereCTRI/2020/05/025271Cadila Pharmaceuticals Limited481