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

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:

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human

U.S. FDA Resources

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:	September 2014
Estimated Primary Completion Date:	September 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

Contacts

Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 40 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:	May 14, 2013
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 May 19, 2013