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

NCT02588950 | Terminated Phase 1 Results

• 2 other identifiers: 16021B5K-EW-IBHG
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

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

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

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

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

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

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

Secondary Outcomes (5)

• 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

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

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

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

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

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

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

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

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

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

Study Arms (4)

Part A: U-500R Single Injection

EXPERIMENTAL

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

Drug: U-500R

Part A: U-500R CSII

EXPERIMENTAL

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

Drug: U-500R

Part B: U-500R TID

EXPERIMENTAL

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

Drug: U-500R

Part B: U-500R BID

EXPERIMENTAL

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

Drug: U-500R

Interventions

U-500R DRUG

Also known as: Humulin R U-500, LY041001, Humulin

Part A: U-500R CSII; Part A: U-500R Single Injection; Part B: U-500R BID; Part B: U-500R TID

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (%)

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin, Regular, Human

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: January 12, 2016
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: October 23, 2023
• Results First Posted: October 18, 2023

Record last verified: 2023-10

Locations

US (1)