Phase 1
Completed N=8
A Study of LY2605541 Versus Insulin Glargine on Blood Sugar
Healthy Volunteers · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01654380 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Part B: Glucodynamics: Endogenous Glucose Output — 64.53; 99.23; 78.05; 97.05 percent of suppression
Summary
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part B: Glucodynamics: Endogenous Glucose Output |
64.53; 99.23; 78.05; 97.05 | — |
| PRIMARY Part B: Glycodynamics: Glucose Disposal |
0.68; 1.42; 0.98; 1.85 | — |
| PRIMARY Part B: Glycodynamics: Maximum Rate of Glucose Disposal |
1.80; 2.89; 2.15; 3.55 | — |
Eligibility Criteria
Inclusion Criteria
All Participants
- Are healthy males or participants with T1DM
- Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m^2)
Healthy Participants ONLY
- Are overtly healthy, as determined by medical history and physical examination
- Have a fasting blood glucose 400 mg/dL
Data sourced from ClinicalTrials.gov (NCT01654380). 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.