Study Condition(s): Adult Type 2 Diabetes

An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants with Type 2 Diabetes Mellitus (VIVID)

Study Alias: IBHD

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02561078 {{ currentLocaleObject.registryAnchorText }}

Withdrawn Active, not recruiting

Study Purpose

The main purpose of this study is to evaluate the safety and efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18 years
85 years

Time Commitment

Your participation could last up to 26 weeks and include 10 visits to the study center
  • Participant must be diagnosed with type 2 diabetes mellitus (T2DM)

  • Participant must not be diagnosed with type 1 diabetes mellitus (T1DM) or other types of diabetes apart from T2DM

  • Participant must have been on the same insulin for >3 months and have a current Total Daily Dose of insulin >200 units but < 600 units

  • Participant must not have a history of more than 1 episode of severe hypoglycemia requiring the assistance of another person, resulting in coma, seizures or disorientation within the 6 months prior to study entry

  • Participant must not have chronic kidney disease Stage 4 and higher, or history of renal transplantation

  • Participant must not have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia

  • Participant must not have used any weight loss drugs in the 3 months prior to screening

  • Participant must not have a history of bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve

  • Female participant must not be pregnant or breastfeeding, or intend to become pregnant during the course of the study

  • Male participant must agree to practice a medically acceptable birth control method

Where to Participate

57 locations are currently available of 65 planned
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