Recruitment

Recruitment Status
Completed

Inclusion Criteria

Have a serum creatinine value within normal limits at screening
Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment
Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening
...
Have a serum creatinine value within normal limits at screening
Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment
Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening
Have a haemoglobin A1c (HbA1c) value ≤75 millimoles per mole (mmol/mol) (9.0%) at screening
Have a body mass index (BMI) of 20.0-30.0 kilograms per meter squared (kg/m^2), inclusive, at screening

Exclusion Criteria

Have proliferative retinopathy or maculopathy
Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
Have any wound healing disorder or are prone to keloid or hypertrophic scar formation
...
Have proliferative retinopathy or maculopathy
Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
Have any wound healing disorder or are prone to keloid or hypertrophic scar formation
Have results of screening prothrombin time (PT) and international normalized ratio (INR) tests that are significantly prolonged
Regular use or intended use of non-selective beta blockers
Have a total daily insulin dose greater than 1.2 units per kilogram (U/kg)
Are women who are pregnant or lactating
Are unwilling to avoid excessive sun exposure, steam baths, saunas, and swimming during the study. Sun cream should be used during sun bathing for the 6-month period following the study
Regular use or intended use of monoamine oxidase (MAO) inhibitors
Have renal insufficiency or major renal disorders
Have lipodystrophy
Are unwilling to avoid extensive consumption of food containing inulin during the study and in the 48-hour period leading up to the clamp
Have an abnormal blood pressure for the population as determined by the investigator
Are receiving chronic systemic or inhaled glucocorticoid or have received such therapy within the 4 weeks before dosing
Have known or suspected allergies or hypersensitivities to LY2605541, human insulin, sinistrin, related compounds or any components of the formulations
Have a fasting triglycerides value > 4.52 millimoles per liter (mmol/L) (400 milligrams/deciliter (mg/dL))
Are currently participating in a weight loss program or plan to do so during the course of the study

Summary

Conditions
  • Diabetes Mellitus - Type 1
  • Diabetes Mellitus, Type 1
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criteria

Have a serum creatinine value within normal limits at screening
Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment
Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening
...
Have a serum creatinine value within normal limits at screening
Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) based on medical history for at least 1 year prior to enrollment
Have a c-peptide value ≤0.3 nanomoles per liter (nmol/L) at screening
Have a haemoglobin A1c (HbA1c) value ≤75 millimoles per mole (mmol/mol) (9.0%) at screening
Have a body mass index (BMI) of 20.0-30.0 kilograms per meter squared (kg/m^2), inclusive, at screening

Exclusion Criteria

Have proliferative retinopathy or maculopathy
Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
Have any wound healing disorder or are prone to keloid or hypertrophic scar formation
...
Have proliferative retinopathy or maculopathy
Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
Have any wound healing disorder or are prone to keloid or hypertrophic scar formation
Have results of screening prothrombin time (PT) and international normalized ratio (INR) tests that are significantly prolonged
Regular use or intended use of non-selective beta blockers
Have a total daily insulin dose greater than 1.2 units per kilogram (U/kg)
Are women who are pregnant or lactating
Are unwilling to avoid excessive sun exposure, steam baths, saunas, and swimming during the study. Sun cream should be used during sun bathing for the 6-month period following the study
Regular use or intended use of monoamine oxidase (MAO) inhibitors
Have renal insufficiency or major renal disorders
Have lipodystrophy
Are unwilling to avoid extensive consumption of food containing inulin during the study and in the 48-hour period leading up to the clamp
Have an abnormal blood pressure for the population as determined by the investigator
Are receiving chronic systemic or inhaled glucocorticoid or have received such therapy within the 4 weeks before dosing
Have known or suspected allergies or hypersensitivities to LY2605541, human insulin, sinistrin, related compounds or any components of the formulations
Have a fasting triglycerides value > 4.52 millimoles per liter (mmol/L) (400 milligrams/deciliter (mg/dL))
Are currently participating in a weight loss program or plan to do so during the course of the study

Tracking Information

NCT #
NCT02109029
Collaborators
Not Provided
Investigators
Study Director: 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
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