- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774968
Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes
September 3, 2015 updated by: Eli Lilly and Company
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
325
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bayamon, Puerto Rico, 00956
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Las Lomas, Puerto Rico, 00921
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manati, Puerto Rico, 00674
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Juan, Puerto Rico, 00917-3104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Alabama
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Mobile, Alabama, United States, 36617
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arkansas
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Little Rock, Arkansas, United States, 72205
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Concord, California, United States, 94520
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fresno, California, United States, 93720
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Jacksonville, Florida, United States, 32216
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tampa, Florida, United States, 33619
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Palm Beach, Florida, United States, 33401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hawaii
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Honolulu, Hawaii, United States, 96813
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Idaho
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Idaho Falls, Idaho, United States, 83404
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Illinois
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Crystal Lake, Illinois, United States, 60012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Iowa
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Des Moines, Iowa, United States, 50314
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kansas
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Topeka, Kansas, United States, 66606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kentucky
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Louisville, Kentucky, United States, 40206
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maine
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Bangor, Maine, United States, 04401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maryland
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Baltimore, Maryland, United States, 21204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Columbia, Missouri, United States, 65212
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Springfield, Missouri, United States, 65807
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nebraska
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Omaha, Nebraska, United States, 68131
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Las Vegas, Nevada, United States, 89148
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Hampshire
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Nashua, New Hampshire, United States, 03063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Durham, North Carolina, United States, 27713
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Greenville, North Carolina, United States, 27834
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pittsburgh, Pennsylvania, United States, 15224
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Chattanooga, Tennessee, United States, 37411
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nashville, Tennessee, United States, 37212
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Beaumont, Texas, United States, 77701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dallas, Texas, United States, 75390
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
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Norfolk, Virginia, United States, 23507
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Federal Way, Washington, United States, 98003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Olympia, Washington, United States, 98502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Renton, Washington, United States, 98057
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Spokane, Washington, United States, 99202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tacoma, Washington, United States, 98405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Other Names:
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 24
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Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.
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Baseline, Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24
Time Frame: Week 24
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The percentage of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24 was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100.
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Week 24
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30-Day Adjusted Rate of Hypoglycemic Events
Time Frame: Baseline through Week 24
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Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms).
The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
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Baseline through Week 24
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Change From Baseline to Week 24 in Body Weight
Time Frame: Baseline, Week 24
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LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.
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Baseline, Week 24
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Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin
Time Frame: Baseline, Week 24
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Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin.
LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.
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Baseline, Week 24
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Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin
Time Frame: Baseline, Week 24
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Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin.
LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.
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Baseline, Week 24
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Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels
Time Frame: Baseline, Week 24
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LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline FPG as a covariate.
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Baseline, Week 24
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Time to Reach HbA1c Target Values
Time Frame: Baseline through 6, 12, 18, and 24 weeks.
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The cumulative number of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% is summarized at Weeks 6, 12, 18, and 24.
The number of participants at risk (n) is also provided for each target value and timepoint.
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Baseline through 6, 12, 18, and 24 weeks.
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Percentage of Participants With Hypoglycemic Events
Time Frame: Baseline through Week 24
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Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms).
The percentage of participants with HE at 24 weeks was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
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Baseline through Week 24
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Change From Baseline to Week 24 in Number of Insulin Injections
Time Frame: Baseline, Week 24
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The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.
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Baseline, Week 24
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Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)
Time Frame: Baseline, Week 24
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The 7-point SMBG is a participant self-administered blood glucose test which utilizes measurements at specific time points over a 24-hour period, including pre-morning meal (fasting), 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and 3 AM.
LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline SMBG as a covariate.
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Baseline, Week 24
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Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg
Time Frame: Baseline, Week 24
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Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg).
LS means of change from baseline were calculated using MMRM with investigator, baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.
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Baseline, Week 24
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Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg
Time Frame: Baseline, Week 24
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Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg).
Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (DS; an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), or nocturnal (Noc; any documented symptomatic HE that occurred between bedtime and waking).
The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
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Baseline, Week 24
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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
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Participants were stratified by their baseline TDD insulin (≤2.0 units (U)/kg or >2.0 U/kg).
The percentage of participants at risk of developing hypoglycemia (including documented symptomatic, asymptomatic, probable symptomatic, unspecified, or severe hypoglycemia) is presented at Baseline and at Week 24 and was calculated using MMRM fit with options of the binomial distribution and log link function including treatment, TDD (>300 units or ≤300 units), pioglitazone use (yes or no), visit, and treatment-by-visit interaction as fixed effects, and baseline HbA1c value as a covariate.
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Baseline, Week 24
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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
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Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg).
LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.
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Baseline, Week 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kabul S, Hood RC, Duan R, DeLozier AM, Settles J. Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial. Health Qual Life Outcomes. 2016 Sep 30;14(1):139. doi: 10.1186/s12955-016-0541-4.
- Mari A, Rosenstock J, Ma X, Li YG, Jackson JA. OPTIMIZED HUMAN REGULAR U-500 INSULIN TREATMENT IMPROVES beta-CELL FUNCTION IN SEVERELY INSULIN-RESISTANT PATIENTS WITH LONG-STANDING TYPE 2 DIABETES AND HIGH INSULIN REQUIREMENTS. Endocr Pract. 2015 Dec;21(12):1344-52. doi: 10.4158/EP15898.OR. Epub 2015 Aug 26. Erratum In: Endocr Pract. 2016 May;22(5):646.
- Hood RC, Arakaki RF, Wysham C, Li YG, Settles JA, Jackson JA. TWO TREATMENT APPROACHES FOR HUMAN REGULAR U-500 INSULIN IN PATIENTS WITH TYPE 2 DIABETES NOT ACHIEVING ADEQUATE GLYCEMIC CONTROL ON HIGH-DOSE U-100 INSULIN THERAPY WITH OR WITHOUT ORAL AGENTS: A RANDOMIZED, TITRATION-TO-TARGET CLINICAL TRIAL. Endocr Pract. 2015 Jul;21(7):782-93. doi: 10.4158/EP15612.OR. Epub 2015 Mar 26. Erratum In: Endocr Pract. 2016 Jul;22(7):905. Dosage error in article text.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (ACTUAL)
May 1, 2014
Study Completion (ACTUAL)
May 1, 2014
Study Registration Dates
First Submitted
January 22, 2013
First Submitted That Met QC Criteria
January 22, 2013
First Posted (ESTIMATE)
January 24, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 22, 2015
Last Update Submitted That Met QC Criteria
September 3, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14838
- B5K-US-IBHC (OTHER: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of MinnesotaEli Lilly and CompanyCompletedInsulin Resistance | Type 2 Diabetes | High Insulin RequirementsUnited States
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Biocon LimitedProfil Institut für Stoffwechselforschung GmbHCompleted
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Profil Institut für Stoffwechselforschung GmbHEmisphere Technologies, Inc.Completed
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Eli Lilly and CompanyTerminatedDiabetes Mellitus, Type 2United States
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PfizerTerminatedDiabetes MellitusUnited States
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Florian SchmitzbergerCompleted
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Mountain Diabetes and Endocrine CenterCompletedInsulin Resistance | Type 2 DiabetesUnited States
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Robert SilbergleitAmerican Heart AssociationCompletedHealthy | Out-Of-Hospital Cardiac ArrestUnited States
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University of WashingtonNational Institute on Aging (NIA)CompletedMild Cognitive Impairment | Alzheimer's DiseaseUnited States