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

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Human regular U-500 insulin (CSII); Drug: Human regular U-500 insulin (MDI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02561078

B5K-MC-IBHD (Other Identifier)

14902

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.

Enrollment: 420 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with type 2 diabetes mellitus (T2DM).

• Current TDD >200 but ≤600 units of non U-500R insulin (MDI or CSII) and/or U-500R by MDI with syringe and vial for ≥3 months at entry.

  • If TDD of U-500R and other insulins are combined, then insulin other than U-500R not to exceed 25% of TDD.

• HbA1c ≥7.5% and ≤12.0%.

• Body mass index ≥25 but ≤50 kilograms per meter squared.

• Have a history of stable body weight.

• Concomitant antihyperglycemic agent (AHA) therapy may include metformin (MET), dipeptidyl peptidase-4 inhibitors and/or pioglitazone.

  • Approximately 64 to 96 subjects using glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors will be enrolled in Study Group B.

Exclusion criteria

• Diagnosed with type 1 diabetes mellitus (T1DM) or other types of diabetes apart from T2DM.
• Have obvious clinical or radiographic signs or symptoms of liver disease (except nonalcoholic fatty liver disease), cirrhosis, acute or chronic hepatitis, or alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) levels ≥2.5X upper limit of normal (ULN), alkaline phosphatase ≥2X ULN or total bilirubin ≥2X ULN.
• Have chronic kidney disease Stage 4 and higher or history of renal transplantation.
• Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to screening.
• Have received U-500R insulin by CSII in the 3 months prior to screening.
• 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.
• Are taking chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy.
• Have an irregular sleep/wake cycle.
• Have used any weight loss drugs in the 3 months prior to screening.
• Have a history of bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve.
• Have a history of an active or untreated malignancy, or in remission from a clinically significant malignancy during the last 5 years before screening.
• Significant hearing loss and/or vision impairment deemed by the investigator to interfere with the safe use of OmniPod U-500 system.
• Have cardiac disease with functional status that is New York Heart Association (NYHA) Class III or IV per New York Heart Association Cardiac Disease Functional Classification or have congestive heart failure requiring pharmacologic treatment.
• Are women breastfeeding or pregnant, or intend to become pregnant during the course of the study; are men who intend to impregnate their partners; or are sexually active of procreation potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Human regular U-500 insulin administered by CSII

Experimental group

Description:

Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in.

Treatment:

Drug: Human regular U-500 insulin (CSII)

Human regular U-500 insulin administered by MDI

Active Comparator group

Description:

Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks.

Treatment:

Drug: Human regular U-500 insulin (MDI)