A Study in Type 2 Diabetes
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 14.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-001254-29-IT
- Lead Sponsor
- ELI LILLY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1325
Male or female patients diagnosed with T2DM (for at least 1 year), aged =18 years, with a body mass index =45.0 kg/m2. Patients should have HbA1c value =7.0% to <12.0% at screening; and be taking at least 1 injection of insulin per day with or without OAMs
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 994
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 331
. Patients should not have had any episode of severe hypoglycemia or have had 2 or more emergency room visits/ hospitalizations due to poor glucose control or 1 or more hospitalizations for episodes of ketoacidosis or hyperosmolar state/coma within 6 months prior to Visit 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method