NCT01867216

Brief Summary

The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

May 28, 2013

Results QC Date

September 27, 2017

Last Update Submit

July 25, 2018

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.

    Baseline through Study Completion (up to 56 days)

Secondary Outcomes (6)

  • Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470

    Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose

  • Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470

    Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose

  • Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470

    Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose

  • Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28

    Baseline, Day 28

  • Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28

    Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days

Drug: Placebo

LY2922470

EXPERIMENTAL

Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days

Drug: LY2922470

Interventions

PlaceboDRUG

Administered orally as capsules

Placebo
LY2922470DRUG

Administered orally as capsules

LY2922470

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
  • Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
  • Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
  • Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m\^2)
  • Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

You may not qualify if:

  • Are currently participating in another clinical study or completed one in the last 30 days
  • Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
  • Have electrocardiogram (ECG) readings that are not suitable for the study
  • Are infected with hepatitis B or hepatitis C
  • Are infected with human immunodeficiency virus (HIV)
  • Have donated blood equal to or more than 500 mL within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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.

Chula Vista, California, 91911, United States

Location

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.

Eatontown, New Jersey, 07724, United States

Location

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.

New York, New York, 10013, United States

Location

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.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2922470

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

June 3, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 26, 2018

Results First Posted

July 26, 2018

Record last verified: 2018-07

Locations

US(4)