Phase 1
Completed N=76
A Study of LY2605541 and Glargine and Exercise in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01784211 ↗
Enrolled (actual)
76
Serious AEs
1.3%
Results posted
Mar 2019
Primary outcomePrimary: Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability — 11.3; 19.2 %CV
Summary
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 mealtime insulin throughout the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability |
11.3; 19.2 | — |
| PRIMARY Part A: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Glargine: Intra-Participant Variability |
12.6; 27.7 | — |
| SECONDARY Part A: Pharmacodynamics: Total Amount of Glucose Infused Over the Duration of the Clamp (Gtot): Intra-Participant Variability |
41.4; 63.9 | — |
| SECONDARY Part B: Pharmacokinetics: AUCτ of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise |
147000; 130000; 2950; 2650 | — |
| SECONDARY Part B: Pharmacokinetics: Cmax of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise |
11100; 6760; 166; 153 | — |
Eligibility Criteria
Inclusion Criteria
- Are males or females that have had a diagnosis of Type I Diabetes Mellitus (T1DM) for at least 12 months and are receiving multiple daily insulin injections. Total daily insulin 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 squared (kg/m^2), inclusive
- Have a fasting c-peptide 5 cigarettes per day, or are unwilling to comply with study requirements regarding smoking or use of tobacco products
- Have a hemoglobin level 400 milligrams per deciliter (mg/dL) (4.52 mmol/L)
- Have previous history or family history of deep vein thrombosis
Data sourced from ClinicalTrials.gov (NCT01784211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.