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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01774968
Recruitment Status : Completed
First Posted : January 24, 2013
Results First Posted : May 12, 2015
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Other Names:
  • LY041001
  • Humulin R
  • U-500R
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
Other Names:
  • LY041001
  • Humulin R
  • U-500R


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24 [ Time Frame: 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.

  2. 30-Day Adjusted Rate of Hypoglycemic Events [ Time Frame: Baseline through Week 24 ]
    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.

  3. Change From Baseline to Week 24 in Body Weight [ Time Frame: Baseline, Week 24 ]
    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.

  4. Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin [ Time Frame: Baseline, Week 24 ]
    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.

  5. Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin [ Time Frame: Baseline, Week 24 ]
    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.

  6. Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels [ Time Frame: Baseline, Week 24 ]
    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.

  7. Time to Reach HbA1c Target Values [ Time Frame: Baseline through 6, 12, 18, and 24 weeks. ]
    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.

  8. Percentage of Participants With Hypoglycemic Events [ Time Frame: Baseline through Week 24 ]
    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.

  9. Change From Baseline to Week 24 in Number of Insulin Injections [ Time Frame: Baseline, Week 24 ]
    The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.

  10. Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline, Week 24 ]
    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.

  11. 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 ]
    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.

  12. 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 ]
    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.

  13. 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 ]
    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.

  14. 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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774968


Locations
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United States, Alabama
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Mobile, Alabama, United States, 36617
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Concord, California, United States, 94520
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Fresno, California, United States, 93720
United States, Florida
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Jacksonville, Florida, United States, 32216
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Tampa, Florida, United States, 33619
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West Palm Beach, Florida, United States, 33401
United States, Hawaii
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Honolulu, Hawaii, United States, 96813
United States, Idaho
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Crystal Lake, Illinois, United States, 60012
United States, Iowa
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Des Moines, Iowa, United States, 50314
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Louisville, Kentucky, United States, 40206
United States, Maine
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Bangor, Maine, United States, 04401
United States, Maryland
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Baltimore, Maryland, United States, 21204
United States, Missouri
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Columbia, Missouri, United States, 65212
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Springfield, Missouri, United States, 65807
United States, Nebraska
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Omaha, Nebraska, United States, 68131
United States, Nevada
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Las Vegas, Nevada, United States, 89148
United States, New Hampshire
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Nashua, New Hampshire, United States, 03063
United States, North Carolina
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Durham, North Carolina, United States, 27713
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Greenville, North Carolina, United States, 27834
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
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Chattanooga, Tennessee, United States, 37411
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Nashville, Tennessee, United States, 37212
United States, Texas
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Beaumont, Texas, United States, 77701
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Dallas, Texas, United States, 75390
United States, Virginia
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Norfolk, Virginia, United States, 23507
United States, Washington
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Federal Way, Washington, United States, 98003
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Olympia, Washington, United States, 98502
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Renton, Washington, United States, 98057
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Spokane, Washington, United States, 99202
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Tacoma, Washington, United States, 98405
Puerto Rico
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Bayamon, Puerto Rico, 00956
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Las Lomas, Puerto Rico, 00921
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Manati, Puerto Rico, 00674
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San Juan, Puerto Rico, 00917-3104
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01774968    
Other Study ID Numbers: 14838
B5K-US-IBHC ( Other Identifier: Eli Lilly and Company )
First Posted: January 24, 2013    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: September 22, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs