Back to resultsA Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LY2963016
Lantus
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
- have had a duration of diabetes ≥1 year
- have hemoglobin A1c ≤10.0%
- have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
- have a body mass index ≤29 kilograms per square meter (kg/m²)
- have venous access sufficient to allow blood sampling and cannulation for clamp procedures
Exclusion Criteria:
- are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
- have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
- have a history of proliferative retinopathy
- have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
- have an electrocardiogram (ECG) reading considered outside the normal limits
- have an abnormal blood pressure
- have abnormal clinical laboratory tests
- have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
- show evidence of significant active neuropsychiatric disease
- regular use of known drugs of abuse and/or show positive findings on drug screening
- show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
- show evidence of hepatitis C and/or positive hepatitis C antibody
- show evidence of hepatitis B and/or positive hepatitis B surface antigen
- are women with a positive pregnancy test or women who are lactating
- have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)
- had more than 1 episode of severe hypoglycemia within 6 months prior to study
- undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
- had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia
- are receiving systemic glucocorticoid therapy
- have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)
- show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia
- smoke more than 10 cigarettes (or equivalent other tobacco products) per day
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LY2963016
Lantus
Arm Description
A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.
A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
Outcomes
Primary Outcome Measures
Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
Secondary Outcome Measures
Maximum Glucose Infusion Rate (Rmax)
Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.
Total Glucose Infused (Gtot)
Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.
Time of Maximum Glucose Infusion Rate (tRmax)
tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus
Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus
AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01600950
Brief Title
A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
Official Title
Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY2963016
Arm Type
Experimental
Arm Description
A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days.
Arm Title
Lantus
Arm Type
Active Comparator
Arm Description
A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
Intervention Type
Drug
Intervention Name(s)
LY2963016
Intervention Description
Single 0.3 U/kg dose administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Lantus
Intervention Description
Single 0.3 U/kg dose administered subcutaneously
Primary Outcome Measure Information:
Title
Pharmacodynamics: Duration of Action of LY2963016 and Lantus
Description
Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.
Time Frame
Periods 1 and 2: Baseline up to 42 hours postdose
Secondary Outcome Measure Information:
Title
Maximum Glucose Infusion Rate (Rmax)
Description
Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.
Time Frame
Periods 1 and 2: Baseline up to 42 hours postdose
Title
Total Glucose Infused (Gtot)
Description
Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.
Time Frame
Periods 1 and 2: Baseline up to 42 hours postdose
Title
Time of Maximum Glucose Infusion Rate (tRmax)
Description
tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.
Time Frame
Periods 1 and 2: Baseline up to 42 hours postdose
Title
Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus
Description
Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
Time Frame
Periods 1 and 2: Baseline up to 42 hours postdose
Title
Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus
Description
AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.
Time Frame
Periods 1 and 2: Baseline up to 42 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
have type 1 diabetes mellitus (T1DM) based on the disease diagnostic criteria
have had a duration of diabetes ≥1 year
have hemoglobin A1c ≤10.0%
have fasting C-peptide ≤0.3 nanomoles per liter (nmol/L)
have a body mass index ≤29 kilograms per square meter (kg/m²)
have venous access sufficient to allow blood sampling and cannulation for clamp procedures
Exclusion Criteria:
are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device
have a total insulin requirement >1.2 units per kilogram per day (U/kg/day)
have a history of proliferative retinopathy
have known allergies to insulin glargine, insulin lispro, heparin, or related compounds
have an electrocardiogram (ECG) reading considered outside the normal limits
have an abnormal blood pressure
have abnormal clinical laboratory tests
have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
history of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first-degree relatives
show evidence of significant active neuropsychiatric disease
regular use of known drugs of abuse and/or show positive findings on drug screening
show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
show evidence of hepatitis C and/or positive hepatitis C antibody
show evidence of hepatitis B and/or positive hepatitis B surface antigen
are women with a positive pregnancy test or women who are lactating
have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females)
had more than 1 episode of severe hypoglycemia within 6 months prior to study
undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer
had a blood transfusion or severe blood loss within 3 months; made a blood donation within 30 days prior to study entry; or have known hemoglobinopathy, haemolytic anemia, or sickle cell anemia
are receiving systemic glucocorticoid therapy
have irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night)
show a history of adverse reactions to heparin, including heparin-induced thrombocytopenia
smoke more than 10 cigarettes (or equivalent other tobacco products) per day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
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A Study to Compare LY2963016 to Lantus After a Single Dose to Participants With Type 1 Diabetes Mellitus
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