A Study of LY2881835 in Healthy People and People With Diabetes

NCT01358981 | Completed Phase 1 Results

• 2 other identifiers: 13747I4P-FW-GPFA
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Adverse Effects

  Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.

  Baseline to study completion up to 3 months

Secondary Outcomes (6)

• Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835

  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

• Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835

  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

• Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835

  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

• Glucose Area Under the Effective Concentration Curve (AUEC)

  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

• Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC)

  Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose

Study Arms (2)

LY2881835

EXPERIMENTAL

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).

Drug: LY2881835

placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

LY2881835 DRUG

Administered orally

LY2881835

Placebo DRUG

Administered orally

placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2881835

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: May 24, 2011
• Primary Completion: August 17, 2011
• Study Completion: August 17, 2011
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)