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A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02588950
Recruitment Status : Terminated (Slow enrollment)
First Posted : October 28, 2015
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This purpose of this two-part study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In Part A, each participant will receive two treatments, a single dose and a continuous dose of U-500R insulin, both administered just under the skin. Participants who complete Part A will continue into Part B where they will be assigned to 1 of 2 treatments with U-500R insulin, injected either twice or three times daily under the skin for 5-10 days. This study can last from 7-14 weeks including initial screening and follow up.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: U-500R Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparative Pharmacokinetics and Pharmacodynamics of Human Regular U-500 Insulin Administered Subcutaneously as a Bolus Via Syringe Versus Continuous Subcutaneous Insulin Infusion and Characterization of TID and BID Dosing at Steady State in High-Dose Insulin-Treated Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : January 12, 2016
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : May 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A: U-500R Single Injection
Bolus of U-500R administered via single subcutaneous (SC) injection in one of the two periods
Drug: U-500R
Administered SC
Other Name: Humulin, LY041001

Experimental: Part A: U-500R CSII
Bolus of U-500R administered via continuous subcutaneous insulin infusion (CSII) in one of the two periods
Drug: U-500R
Administered SC
Other Name: Humulin, LY041001

Experimental: Part B: U-500R TID
U-500R administered thrice-daily (TID) via SC injection under steady state conditions for 5 to 10 days
Drug: U-500R
Administered SC
Other Name: Humulin, LY041001

Experimental: Part B: U-500R BID
U-500R administered twice-daily (BID) via SC injection under steady state conditions for 5 to 10 days
Drug: U-500R
Administered SC
Other Name: Humulin, LY041001




Primary Outcome Measures :
  1. Part A: Pharmacokinetics: Time to Maximum Drug Concentration (Tmax) of U-500R [ Time Frame: Predose through 24 hours postdose ]
  2. Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC[0-24]) of U-500R [ Time Frame: Predose (Day 1 of Study Period 3) through 24 hours postdose ]
  3. Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R [ Time Frame: Predose (Day 1 of Study Period 3) through 24 hours postdose ]
  4. Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R [ Time Frame: Predose (Day 1 of Study Period 3) through 24 hours post-clamp procedure ]

Secondary Outcome Measures :
  1. Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R [ Time Frame: Predose through 24 hours postdose ]
  2. Part A: Pharmacodynamics: Time to Rmax (tRmax) of U-500R [ Time Frame: Predose through 24 hours post-clamp procedure ]
  3. Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R [ Time Frame: Predose (Day 1 of Study Period 3) through 24 hours postdose ]
  4. Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R [ Time Frame: Predose (Day 1 of Study Period 3) through 24 hours post-clamp procedure ]
  5. Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R [ Time Frame: Predose (Day 1 of Study Period 3) through 24 hours post-clamp procedure ]


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females with type 2 diabetes mellitus (T2DM)
  • Are current users of U-100, U-200 and/or U-300 insulin/analog as, basal, premixed and/or basal/bolus delivered with any injection device (pens and/or syringe/vial but excluding continuous subcutaneous infusion (CSII)/insulin pump use in the preceding 3 months), taking a total daily dose (TDD) of greater than or equal to (≥) 150 units (U) or at least one dose greater than (>) 100 U as part of a multiple daily injection (MDI) regimen and TDD less than or equal to (≤)3.0 units per kilogram (U/kg)
  • Concomitant antihyperglycemic agent(s) (AHA) therapy may include: metformin (MET), dipeptidyl peptidase 4 inhibitors, pioglitazone (doses ≤30 milligrams per day (mg/day)), glucagon like peptide (GLP)-1 receptor agonists, sodium-glucose co-transporter-2 (SGLT2) inhibitors, except in combination with GLP-1 receptor agonists
  • Participant's antihyperglycemic agent (AHA) therapy must have been stable for ≥3 months (except for weekly GLP-1 receptor agonists which must have been stable for ≥4 months)
  • Have hemoglobin A1c (HbA1c) 7.5-11.5 percent (%)

Exclusion Criteria:

  • Have type 1 diabetes mellitus (T1DM), or other types of diabetes mellitus apart from T2DM
  • Have known hypersensitivities or allergies to insulin, excipients contained in insulin products, or related compounds
  • Have used U-500R within 3 months prior to screening
  • Have used rosiglitazone, pramlintide, once weekly or twice daily exenatide, or other injectable or oral antihyperglycemic agent(s) not listed in the inclusion criterion; or are taking oral antidiabetic medications at doses exceeding the respective product labels
  • Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia which may affect reliability of HbA1c measurements

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): NCT02588950


Locations
United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02588950     History of Changes
Other Study ID Numbers: 16021
B5K-EW-IBHG ( Other Identifier: Eli Lilly and Company )
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017

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