Back to resultsA Study of LY2881835 in Healthy People and People With Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
LY2881835
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
All subjects:
- Are a healthy male or a healthy female who cannot become pregnant, or are patients with Type 2 Diabetes Mellitus (T2DM) who are not taking any drugs to lower blood sugar except metformin
- Have a body mass index (BMI) of at least 18.5 kilograms per meter squared (kg/m²) at screening
- Have blood pressure, pulse rate and clinical laboratory tests within the normal range for the population or investigator site, or with abnormalities deemed clinical insignificant by the investigator
- Have veins that are suitable for easy blood collection
- Are reliable and willing to be available for the whole study and are willing to follow study procedures
- Must have given written informed consent
Subjects with Type 2 Diabetes Mellitus (T2DM) only:
- Do not have any change to their diabetes treatment for at least 4 weeks prior to screening
- Have a glycosylated hemoglobin (HbA1c) level greater than or equal to 6% and less than or equal to 11% at screening
Exclusion Criteria:
All subjects:
- Are currently participating in or were in another new drug or medical research study in the last 30 days
- Have participated in this study before
- Have known allergies to compounds related to the study drug
- Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
- Intend to use over-the-counter or prescription medications within 14 days prior to dosing or during the study. Hormone replacement therapy and intermittent use of paracetamol during the study is acceptable. For patients with Type 2 Diabetes Mellitus, medicines for control of high fats (For example, cholesterol), high blood pressure, are allowed.
- Have electrocardiogram (ECG) readings that are not suitable for the study
- Are unwilling to follow dietary restrictions/requirements for the study including 1) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay and 2) consume only the meals provided during inpatient stays at the clinical research unit
- Have a history of drug or alcohol abuse
- Are infected with hepatitis B
- Are infected with human immunodeficiency disease virus (HIV)
- Have donated 450 milliliters (mL) or more of blood in the last 3 months or provided any blood donation within the last month from screening
- Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- The study doctor thinks the subject should not participate for any other reasons
Subjects with Type 2 Diabetes Mellitus (T2DM) only:
- Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment, as determined by the study doctor
- Were hospitalised for poor control of their diabetes (ketoacidotic episode) in the last 6 months
- Currently using or have used insulin in the last 1 year to control their diabetes
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
Placebo Comparator
Arm Label
LY2881835
placebo
Arm Description
One cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose levels). One cohort of participants with Type 2 Diabetes Mellitus (T2DM) will receive single oral doses of LY2881835 in up to 2 of the 3 periods in Part B (dose escalation: starting dose based on review of safety, tolerability, glycaemic response and available PK data from Part A). There is a washout period of at least 5 days between periods (doses).
One cohort of healthy participants will receive a single oral dose of placebo in 1 of the 4 periods in Part A. Another cohort of participants with T2DM will receive a single oral dose of placebo in 1 of the 3 periods in Part B. There is a washout period of at least 5 days between periods (doses).
Outcomes
Primary Outcome Measures
Number of Participants With Clinically Significant Adverse Effects
Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.
Secondary Outcome Measures
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours [AUC(0-24 hours)] is provided.
Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided.
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided.
Glucose Area Under the Effective Concentration Curve (AUEC)
Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours.
Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC)
Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours.
C-Peptide Area Under the Effective Concentration Curve (AUEC)
C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01358981
Brief Title
A Study of LY2881835 in Healthy People and People With Diabetes
Official Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Oral Doses of LY2881835 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 24, 2011 (Actual)
Primary Completion Date
August 17, 2011 (Actual)
Study Completion Date
August 17, 2011 (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
This will be the first study in which LY2881835 is given to humans in order to evaluate the safety and any side effects of LY2881835 in humans as well as how long LY2881835 stays in the body and its effect on blood sugar levels.
The study consists of two parts. In part A, healthy subjects will participate and in part B, patients with type 2 Diabetes Mellitus (T2DM) will participate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY2881835
Arm Type
Experimental
Arm Description
One cohort of healthy participants will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 milligram (mg), 1.5 mg, subsequent doses determined based on review of safety, tolerability, glycaemic response and available pharmacokinetic (PK) data from the first 2 dose levels). One cohort of participants with Type 2 Diabetes Mellitus (T2DM) will receive single oral doses of LY2881835 in up to 2 of the 3 periods in Part B (dose escalation: starting dose based on review of safety, tolerability, glycaemic response and available PK data from Part A).
There is a washout period of at least 5 days between periods (doses).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
One cohort of healthy participants will receive a single oral dose of placebo in 1 of the 4 periods in Part A. Another cohort of participants with T2DM will receive a single oral dose of placebo in 1 of the 3 periods in Part B.
There is a washout period of at least 5 days between periods (doses).
Intervention Type
Drug
Intervention Name(s)
LY2881835
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of Participants With Clinically Significant Adverse Effects
Description
Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.
Time Frame
Baseline to study completion up to 3 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835
Description
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours [AUC(0-24 hours)] is provided.
Time Frame
Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835
Description
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided.
Time Frame
Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
Title
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835
Description
Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided.
Time Frame
Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose
Title
Glucose Area Under the Effective Concentration Curve (AUEC)
Description
Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours.
Time Frame
Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose
Title
Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC)
Description
Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours.
Time Frame
Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose
Title
C-Peptide Area Under the Effective Concentration Curve (AUEC)
Description
C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours.
Time Frame
Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All subjects:
Are a healthy male or a healthy female who cannot become pregnant, or are patients with Type 2 Diabetes Mellitus (T2DM) who are not taking any drugs to lower blood sugar except metformin
Have a body mass index (BMI) of at least 18.5 kilograms per meter squared (kg/m²) at screening
Have blood pressure, pulse rate and clinical laboratory tests within the normal range for the population or investigator site, or with abnormalities deemed clinical insignificant by the investigator
Have veins that are suitable for easy blood collection
Are reliable and willing to be available for the whole study and are willing to follow study procedures
Must have given written informed consent
Subjects with Type 2 Diabetes Mellitus (T2DM) only:
Do not have any change to their diabetes treatment for at least 4 weeks prior to screening
Have a glycosylated hemoglobin (HbA1c) level greater than or equal to 6% and less than or equal to 11% at screening
Exclusion Criteria:
All subjects:
Are currently participating in or were in another new drug or medical research study in the last 30 days
Have participated in this study before
Have known allergies to compounds related to the study drug
Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
Intend to use over-the-counter or prescription medications within 14 days prior to dosing or during the study. Hormone replacement therapy and intermittent use of paracetamol during the study is acceptable. For patients with Type 2 Diabetes Mellitus, medicines for control of high fats (For example, cholesterol), high blood pressure, are allowed.
Have electrocardiogram (ECG) readings that are not suitable for the study
Are unwilling to follow dietary restrictions/requirements for the study including 1) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay and 2) consume only the meals provided during inpatient stays at the clinical research unit
Have a history of drug or alcohol abuse
Are infected with hepatitis B
Are infected with human immunodeficiency disease virus (HIV)
Have donated 450 milliliters (mL) or more of blood in the last 3 months or provided any blood donation within the last month from screening
Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
The study doctor thinks the subject should not participate for any other reasons
Subjects with Type 2 Diabetes Mellitus (T2DM) only:
Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment, as determined by the study doctor
Were hospitalised for poor control of their diabetes (ketoacidotic episode) in the last 6 months
Currently using or have used insulin in the last 1 year to control their diabetes
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 9AM - 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
Singapore
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Learn more about this trial
A Study of LY2881835 in Healthy People and People With Diabetes
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