Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Human Regular U-500 Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01774968

14838

B5K-US-IBHC (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.

Enrollment: 325 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• Have type 2 diabetes mellitus (World Health Organization [WHO] Classification of Diabetes)
• Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m^2)
• Have Glycated Hemoglobin A1c (HbA1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry
• Current U-100 insulin/analogue users on >200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization
• Have a history of stable body weight for at least 3 months prior to study entry
• Concomitant medications may include metformin (MET), dipeptidyl peptidase-4 (DPP-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (SUs)/glinides (repaglinide or nateglinide). Participant's oral antihyperglycemic drug (OAD) dose(s) must have been stable for ≥3 months

Major Exclusion Criteria:

• Have type 1 diabetes mellitus or other types of diabetes mellitus apart from type 2 diabetes mellitus
• Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range
• 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 study entry
• Have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry
• Have received U-500R in the 3 months prior to study entry
• Have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia
• Are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry
• Have an irregular sleep/wake cycle
• Have used rosiglitazone, once- or twice-daily glucagon-like peptide-1 (GLP-1) receptor agents, pramlintide, or other injectable or oral antihyperglycemic therapy not listed in the inclusion criteria in the 3 months prior to study entry. Participants may not have used once-weekly GLP-1 receptor agents in the 4 months prior to study entry
• Have used any weight loss drugs in the 3 months prior to study entry
• Have a history of bariatric surgery
• Have a history of malignancy other than basal cell or squamous cell skin cancer
• Have New York Heart Association (NYHA) Class III or IV per NYHA Cardiac Disease Functional Classification
• Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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325 participants in 2 patient groups

Human Regular U-500 Insulin TID

Experimental group

Description:

Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.

Treatment:

Drug: Human Regular U-500 Insulin

Human Regular U-500 Insulin BID

Experimental group

Description:

U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.

Treatment:

Drug: Human Regular U-500 Insulin