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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02588950
• Other study ID #: 16021
• Secondary ID: B5K-EW-IBHG
• Status: Terminated
• Phase: Phase 1
• Start date: January 12, 2016
• Est. completion date: May 25, 2017

Study information

• Verified date: October 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• U-500R

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose
Secondary	Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R	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
Secondary	Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R	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
Secondary	Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R	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
Secondary	Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R	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

External Links

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