EUCTR2011-001254-29-ITActive, not recruitingNot Applicable
The Impact of LY2605541 versus Insulin Glargine forPatients with Type 2 Diabetes Mellitus Advanced toMultiple Injection Bolus Insulin with Insulin Lispro: aDouble-Blind, Randomized, 26-Week StudyThe IMAGINE 4 Study - IMAGINE 4
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ELI LILLY
- Enrollment
- 1,325
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •. 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.
Investigators
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Phase 3
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A Study in Type 2 DiabetesMedDRA version: 14.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 DiabetesEUCTR2011-000842-39-ITELI LILLY1,516
