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A Study of LY2605541 and Glargine and Exercise in Participants With Type 1 Diabetes

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: LY2605541 (Drug); Insulin Glargine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company


The purpose of this study is to measure how much of the study drug or insulin glargine gets into the blood stream and how long it takes the body to get rid of it. The effect of exercise will also be evaluated. This study has two parts. In Part A, each participant will receive a daily injection of LY2605541 or insulin glargine for about 15 days. Some participants may continue into Part B. In Part B, participants will receive a daily injection of LY2605541 or insulin glargine with or without exercise. Part B lasts about 6 days. Participants will remain on their regular physician-prescribed meal time insulin throughout the study.

Clinical Details

Official title: The Pharmacokinetic and Pharmacodynamic Intra-subject Variability of LY2605541 and the Effect of Exercise on LY2605541 Pharmacokinetics in Patients With Type 1 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability

Part A: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Glargine: Intra-Participant Variability

Secondary outcome:

Part A: Pharmacodynamics: Total Amount of Glucose Infused Over the Duration of the Clamp (Gtot): Intra-Participant Variability

Part B: Pharmacokinetics: AUCτ of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise

Part B: Pharmacokinetics: Cmax of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Are males or females that have had a diagnosis of Type I Diabetes Mellitis (T1DM) for

at least 12 months and are receiving multiple daily insulin injections. Total daily insulin dose <1. 2 units per kilogram per day (U/kg/day); daily basal dose >0. 2 U/kg/day

- Female participants are women of child-bearing potential who test negative for

pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study

- Have a body mass index (BMI) of 18 to 30 kilograms per meter square (kg/m^2),


- Have a fasting c-peptide <0. 3 nanomoles per liter (nmol/L)

- Have a hemoglobin A1c (HbA1c) < 9% at screening

Participants with T1DM are eligible for enrollment in Part B of the study only if they meet all of the following criteria:

- Have a maximal oxygen uptake (VO2 max) of ≥ 25 milliliters (ml) of oxygen per

kilogram per minute (O2/kg/min) (for women) or ≥ 30 ml O2/kg/min (for men)

- Perform regular physical cardiorespiratory activity to achieve an average total

energy expenditure of ≥ 500 metabolic equivalent of task (MET)-minutes per week during the last 3 months prior to screening Exclusion Criteria:

- Have known allergies to LY2605541, insulin glargine, related compounds or any

components of the formulation

- Have a history of or current cardiovascular, respiratory, hepatic, renal,

gastrointestinal, endocrine (apart from type 1 diabetes), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

- Have had episodes of severe hypoglycemia in the past 6 months (severe hypoglycemia is

defined as having neurological symptoms consistent with neuroglycopenia and having required assistance in treatment by a second party)

- Have a history of hypoglycemia unawareness

- Regular use or intended use of any over-the-counter or prescription medications or

nutritional supplements that may affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing

- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age

65) and 14 units per week (males over 65 and females), or are unwilling to comply with study requirements regarding alcohol consumption

- Currently smokes > 5 cigarettes per day, or are unwilling to comply with study

requirements regarding smoking or use of tobacco products

- Have a hemoglobin level <8. 0 millimoles per liter (mmol/L) (male) or <6. 4 mmol/L

(female) at screening

- Are currently participating in a weight loss program or plan to do so during the

course of the study

- Are receiving chronic (lasting longer than 14 consecutive days) systemic

glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing

- Have fasting triglycerides >400 milligrams per deciliter (mg/dL) (4. 52 mmol/l)

- Have previous history or family history of deep vein thrombosis

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Neuss, Germany
Additional Information

Starting date: February 2013
Last updated: November 27, 2013

Page last updated: August 23, 2015

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