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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

U-500R

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Profil Institute for Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Part A: U-500R Single Injection

Part A: U-500R CSII

Part B: U-500R TID

Part B: U-500R BID

Arm Description

Bolus of U-500R administered via single subcutaneous (SC) injection.

Bolus of U-500R administered via continuous subcutaneous insulin infusion (CSII).

U-500R administered thrice-daily (TID) via SC injection under steady state conditions for 5 to 10 days

U-500R administered twice-daily (BID) via SC injection under steady state conditions for 5 to 10 days

Outcomes

Primary Outcome Measures

Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R

Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R.

Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R

Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC[0-24]) of U-500R.

Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R

Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R.

Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R

Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R.

Secondary Outcome Measures

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

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.

Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R

Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R.

Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R

Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R.

Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R

Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R.

Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R

Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R.

Full Information

NCT ID

NCT02588950

First Posted

October 27, 2015

Last Updated

October 18, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02588950

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment

Study Start Date

January 12, 2016 (Actual)

Primary Completion Date

May 25, 2017 (Actual)

Study Completion Date

May 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The 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 single dose with continuous infusion 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: U-500R Single Injection

Arm Type

Experimental

Arm Description

Bolus of U-500R administered via single subcutaneous (SC) injection.

Arm Title

Part A: U-500R CSII

Arm Type

Experimental

Arm Description

Bolus of U-500R administered via continuous subcutaneous insulin infusion (CSII).

Arm Title

Part B: U-500R TID

Arm Type

Experimental

Arm Description

U-500R administered thrice-daily (TID) via SC injection under steady state conditions for 5 to 10 days

Arm Title

Part B: U-500R BID

Arm Type

Experimental

Arm Description

U-500R administered twice-daily (BID) via SC injection under steady state conditions for 5 to 10 days

Intervention Type

Drug

Intervention Name(s)

U-500R

Other Intervention Name(s)

Humulin R U-500, LY041001, Humulin

Primary Outcome Measure Information:

Title

Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R

Description

Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R.

Time Frame

Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24 hours (h) post dose

Title

Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R

Description

Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC[0-24]) of U-500R.

Time Frame

Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

Title

Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R

Description

Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R.

Time Frame

Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

Title

Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R

Description

Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R.

Time Frame

Period 3 day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18h post dose

Secondary Outcome Measure Information:

Title

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

Description

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

Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose

Title

Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R

Description

Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R.

Time Frame

Period 1 and 2: 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose

Title

Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R

Description

Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R.

Time Frame

Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

Title

Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R

Description

Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R.

Time Frame

Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

Title

Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R

Description

Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R.

Time Frame

Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Profil Institute for Clinical Research

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.lillytrialguide.com/en-US/studies/type-2%20diabetes/IBHG#?postal=

Description

Click here for more information about this study: A Study of U-500 Insulin (Humulin LY041001) in Participants With Type 2 Diabetes

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

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