Diabetes Mellitus, Type 2Phase 4NCT01774968

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

A Phase 4 study testing Human Regular U-500 Insulin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 39 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Human Regular U-500 Insulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 325 participants
Where: 39 sitesin 2 countries
Study dates: Feb 2013to May 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

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 locations and contacts

39 sites in 2 countries.

Country

City, postcode or hospital

39 sites in 2 countries

United States35 sites

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Baltimore, Maryland, 21204
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Bangor, Maine, 04401
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Beaumont, Texas, 77701
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Chattanooga, Tennessee, 37411
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Columbia, Missouri, 65212
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Concord, California, 94520
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Crystal Lake, Illinois, 60012
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Dallas, Texas, 75390
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Des Moines, Iowa, 50314
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Durham, North Carolina, 27713
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Federal Way, Washington, 98003
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Fresno, California, 93720
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Greenville, North Carolina, 27834
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Honolulu, Hawaii, 96813
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Idaho Falls, Idaho, 83404
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Jacksonville, Florida, 32216
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Las Vegas, Nevada, 89148
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Little Rock, Arkansas, 72205
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Louisville, Kentucky, 40206
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Mobile, Alabama, 36617
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Nashua, New Hampshire, 03063
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Nashville, Tennessee, 37212
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Norfolk, Virginia, 23507
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Oklahoma City, Oklahoma, 73104
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Olympia, Washington, 98502
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Omaha, Nebraska, 68131
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Philadelphia, Pennsylvania, 19107
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Pittsburgh, Pennsylvania, 15224
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Renton, Washington, 98057
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Spokane, Washington, 99202
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Springfield, Missouri, 65807
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Tacoma, Washington, 98405
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Tampa, Florida, 33619
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Topeka, Kansas, 66606
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West Palm Beach, Florida, 33401

Other trials in United States

Puerto Rico4 sites

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.
Bayamón, 00956
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Las Lomas, 00921
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Manati, 00674
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San Juan, 00917-3104

Other trials in Puerto Rico

About this study

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

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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Human Regular U-500 Insulin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human Regular U-500 InsulinDrug
Also called LY041001, Humulin R, U-500R

Study groups in NCT01774968
Study group	Role	What they receive
Human Regular U-500 Insulin TID	Experimental	Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks. Receives: Drug: Human Regular U-500 Insulin
Human Regular U-500 Insulin BID	Experimental	U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks. Receives: Drug: Human Regular U-500 Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)
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.
Measured: Baseline, Week 24

Secondary outcomes (14)

Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24
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.
Measured: Week 24
30-Day Adjusted Rate of Hypoglycemic Events
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.
Measured: Baseline through Week 24
Change From Baseline to Week 24 in Body Weight
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.
Measured: Baseline, Week 24
Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin
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.
Measured: Baseline, Week 24
Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin
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.
Measured: Baseline, Week 24
Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels
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.
Measured: Baseline, Week 24
Time to Reach HbA1c Target Values
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.
Measured: Baseline through 6, 12, 18, and 24 weeks.
Percentage of Participants With Hypoglycemic Events
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.
Measured: Baseline through Week 24
Change From Baseline to Week 24 in Number of Insulin Injections
The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.
Measured: Baseline, Week 24
Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)
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.
Measured: Baseline, Week 24
Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg
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.
Measured: Baseline, Week 24
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
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.
Measured: Baseline, Week 24
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
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.
Measured: Baseline, Week 24
Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg
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.
Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013May 2014

First posted24 Jan 2013 (estimated)
Study startFeb 2013
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 325 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01774968
Sponsor's protocol ID: 14838
Other IDs: B5K-US-IBHC
Status last verified: Sep 2015
First submitted: 22 Jan 2013
Last updated: 22 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 27716283
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.
PubMed 26307903
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.
PubMed 25813411

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01774968
Acronym / sponsor ID: 14838
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 325 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 24 Jan 2013 (estimated)
Results: Posted 12 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Human Regular U-500 Insulin TID	Experimental	Drug: Human Regular U-500 InsulinHuman Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
Human Regular U-500 Insulin BID	Experimental	Drug: Human Regular U-500 InsulinU-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Human Regular U-500 InsulinAlso: LY041001, Humulin R, U-500R	Drug	Human Regular U-500 Insulin BID, Human Regular U-500 Insulin TID

Primary outcome

Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 24
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.

14 secondary outcomes

Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24
Time frame: Week 24
30-Day Adjusted Rate of Hypoglycemic Events
Time frame: Baseline through Week 24
Change From Baseline to Week 24 in Body Weight
Time frame: Baseline, Week 24
Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin
Time frame: Baseline, Week 24
Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin
Time frame: Baseline, Week 24
Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels
Time frame: Baseline, Week 24
Time to Reach HbA1c Target Values
Time frame: Baseline through 6, 12, 18, and 24 weeks.
Percentage of Participants With Hypoglycemic Events
Time frame: Baseline through Week 24
Change From Baseline to Week 24 in Number of Insulin Injections
Time frame: Baseline, Week 24
Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)
Time frame: Baseline, Week 24
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
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
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
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

Results and safety

Results posted to the registry on 12 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Human Regular U-500 Insulin TID	162	132
Human Regular U-500 Insulin BID	163	128

Primary outcome: Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)

Time frame: Baseline, Week 24. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	Human Regular U-500 Insulin TID n = 162	Human Regular U-500 Insulin BID n = 161
Value	-1.12 (0.08)	-1.22 (0.08)

Human Regular U-500 Insulin TID vs Human Regular U-500 Insulin BID: LS Mean Difference: -0.10 (95% CI -0.33 to 0.12), p = 0.3709, Mixed Models Analysis

Population analysed: Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Human Regular U-500 Insulin TID	28 of 162 (17.3%)	80 of 162 (49.4%)	Not reported
Human Regular U-500 Insulin BID	27 of 163 (16.6%)	94 of 163 (57.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27716283Kabul 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.
Derived from this study: PubMed 26307903Mari 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.
Derived from this study: PubMed 25813411Hood 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

39 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Human Regular U-500 Insulin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01774968, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.