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Clinical Trials/EUCTR2011-001254-29-IT
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

ELI LILLY0 sites1,325 target enrollmentStarted: December 28, 2011Last updated:
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

Sponsor
ELI LILLY

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