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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01774968
First received: January 22, 2013
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Human Regular U-500 Insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Treatment Approaches for Human Regular U-500 Insulin (Thrice-Daily Versus Twice-Daily) in Subjects With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Participants Achieving HbA1c of ≤6.5%; <7.0%; <7.5%; and <8.0% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • 30-Day Adjusted Rate of Hypoglycemic Events [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Week 24 in Body Weight [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Week 24 in Total Daily Dose (TDD) of Insulin [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Time to Reach HbA1c Target Values [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Hypoglycemic Events [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Week 24 in Number of Insulin Injections [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 24 in HbA1c based on Baseline TDD Insulin ≥2.0 units/kilogram and <2.0 units/kg [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events based on Baseline TDD Insulin ≥2.0 units/kilogram and <2.0 units/kg [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Week 24 in Percentage of Participants with Hypoglycemic Events based on Baseline TDD Insulin ≥2.0 units/kg and <2.0 units/kg [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Week 24 in Body Weight based on Baseline TDD Insulin ≥2.0 units/kg and <2.0 units/kg [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 325
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Regular U-500 Insulin TID
Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
Drug: Human Regular U-500 Insulin
Administered SC
Other Names:
  • LY041001
  • Humulin R
Experimental: Human Regular U-500 Insulin BID
U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
Drug: Human Regular U-500 Insulin
Administered SC
Other Names:
  • LY041001
  • Humulin R

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 SC 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774968

  Show 39 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01774968     History of Changes
Other Study ID Numbers: 14838, B5K-US-IBHC
Study First Received: January 22, 2013
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014