A Study of LY2881835 in Healthy People and People With Diabetes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: LY2881835 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Oral Doses of LY2881835 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Number of participants with clinically significant adverse effects [ Time Frame: Baseline to study completion (estimate of approximately 3 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics, Area Under the Curve (AUC) [ Time Frame: Predose, and up to 48 hours post dose ] [ Designated as safety issue: No ]
Pharmacokinetics, Maximum concentration (Cmax) [ Time Frame: Predose, and up to 48 hours post dose ] [ Designated as safety issue: No ]
Pharmacokinetics, Time to maximum concentration (tmax) [ Time Frame: Predose, and up to 48 hours post dose ] [ Designated as safety issue: No ]
Glucose, area under the concentration curve (AUC) [ Time Frame: Predose, and up to 48 hours post dose ] [ Designated as safety issue: No ]
Glucagon-like peptide (active GLP-1) area under the concentration curve (AUC) [ Time Frame: Predose, and up to 2.5 hours post dose ] [ Designated as safety issue: No ]
C-peptide, area under the concentration curve (AUC) [ Time Frame: Predose, and up to 24 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2011
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LY2881835 Two cohorts of healthy subjects will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 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 subjects 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 doses.	Drug: LY2881835 Administered orally
Placebo Comparator: placebo Two cohorts of healthy subjects will receive a single oral dose of placebo in 1 of the 4 periods in Part A. One cohort of subjects 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 doses.	Drug: Placebo Administered orally

Arms

Assigned Interventions

Experimental: LY2881835

Two cohorts of healthy subjects will receive single oral doses of LY2881835 in up to 3 of the 4 periods in Part A (dose escalation: 0.5 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 subjects 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 doses.

Drug: LY2881835

Administered orally

Placebo Comparator: placebo

Two cohorts of healthy subjects will receive a single oral dose of placebo in 1 of the 4 periods in Part A. One cohort of subjects 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 doses.

Drug: Placebo

Administered orally

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 who are not taking any drugs to lower blood sugar except metformin
Have a body mass index (BMI) of at least 18.5 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 glycated haemoglobin (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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358981

Locations

Singapore
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.
Singapore, Singapore

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT01358981 History of Changes
Other Study ID Numbers:	13747, I4P-FW-GPFA
Study First Received:	May 20, 2011
Last Updated:	August 26, 2011
Health Authority:	Singapore: Health Sciences Authority

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013