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

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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)

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

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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