NCT01606371

Brief Summary

The main purpose of this study is to determine the safety of LY2409021 in healthy participants and participants with diabetes. The study drug is given as single oral doses. Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing periods. Side effects will be documented. This study is approximately 9 weeks long, not including screening. Screening is required within 6 weeks prior to the start of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

5 months

First QC Date

May 23, 2012

Last Update Submit

May 23, 2012

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Number of participants with one or more drug related adverse events (AEs) or any serious AEs

    From first dose of study drug up to discharge (at least 14 days after last dose)

Secondary Outcomes (7)

  • Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021

    From each dose of study drug up to 14 days post dose

  • Pharmacokinetics: Maximum concentration (Cmax) of LY2409021

    From each dose of study drug up to 14 days post dose

  • Change in fasting blood glucose level

    From each dose of study drug up to 48 hours post dose

  • Change in fasting insulin level

    From each dose of study drug up to 48 hours post dose

  • Change in fasting glucagon level

    From each dose of study drug up to 48 hours post dose

  • +2 more secondary outcomes

Study Arms (11)

Healthy-Placebo

PLACEBO COMPARATOR

Placebo (capsule) administered once, orally

Drug: Placebo

Healthy-2.5 mg LY2409021

EXPERIMENTAL

2.5 mg LY2409021 administered once, orally

Drug: LY2409021

Healthy-10 mg LY2409021

EXPERIMENTAL

10 mg LY2409021 administered once, orally

Drug: LY2409021

Healthy-30 mg LY2409021

EXPERIMENTAL

30 mg LY2409021 administered once, orally

Drug: LY2409021

Healthy-100 mg LY2409021

EXPERIMENTAL

100 mg LY2409021 administered once, orally

Drug: LY2409021

Healthy-250 mg LY2409021

EXPERIMENTAL

250 mg LY2409021 administered once, orally

Drug: LY2409021

Healthy-500 mg LY2409021

EXPERIMENTAL

500 mg LY2409021 administered once, orally

Drug: LY2409021

Diabetic-Placebo

PLACEBO COMPARATOR

Placebo (capsule) administered once, orally

Drug: Placebo

Diabetic-75 mg LY2409021

EXPERIMENTAL

75 mg LY2409021 administered once, orally

Drug: LY2409021

Diabetic-200 mg LY2409021

EXPERIMENTAL

200 mg LY2409021 administered once, orally

Drug: LY2409021

Diabetic-500 mg LY2409021

EXPERIMENTAL

500 mg LY2409021 administered once, orally

Drug: LY2409021

Interventions

PlaceboDRUG

Administered orally

Diabetic-PlaceboHealthy-Placebo
LY2409021DRUG

Administered orally

Diabetic-200 mg LY2409021Diabetic-500 mg LY2409021Diabetic-75 mg LY2409021Healthy-10 mg LY2409021Healthy-100 mg LY2409021Healthy-2.5 mg LY2409021Healthy-250 mg LY2409021Healthy-30 mg LY2409021Healthy-500 mg LY2409021

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For all participants:
  • Must be either a male, or a female who cannot become pregnant, who is either healthy or have type 2 diabetes mellitus (T2DM) but not taking medication for diabetes
  • Have an hemoglobin A1c (HbA1c) value of less than or equal to 10% at screening
  • Have blood and urine laboratory test results that are acceptable for the study
  • For healthy participants:
  • Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m\^2 inclusive
  • Have a fasting blood glucose between 3.0-5.2 millimoles/liter (mmol/L) at screening
  • Have plasma glucose, two hours after ingesting an oral 75 g glucose load, less than 7.8 mmol/L
  • For participants with type 2 diabetes mellitus (T2DM):
  • Have a screening body mass index (BMI) of 18.5 to 35 kg/m\^2 inclusive
  • Must weigh 45 kg or more at screening
  • Have a fasting blood glucose less than 11.1 mmol/L at screening
  • Have plasma glucose, two hours after ingesting an oral 75 g glucose load, greater than or equal to 11.1 mmol/L

You may not qualify if:

  • For all participants:
  • Have participated in a study with a new drug 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 hypertension requiring more than single-agent therapy, or blood pressure greater than 140/90 millimeters of mercury (mmHg) on monotherapy
  • Are allergic to LY2409021 or similar drugs
  • Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
  • Intend to use other over-the-counter or prescribed medicines during 7 or 14 days respectively before the study, or during the study. Medicines for high cholesterol and high blood pressure are allowed if you have diabetes.
  • Have a significant blood disorder and/or donated blood (450 ml or more) in the last 3 months
  • For participants with T2DM:
  • Have signs of having serious problems with diabetes (For example, severe eye problems, poorly healing skin)
  • Have a history of being in a coma due to low blood sugar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Related Publications (1)

  • Kelly RP, Garhyan P, Raddad E, Fu H, Lim CN, Prince MJ, Pinaire JA, Loh MT, Deeg MA. Short-term administration of the glucagon receptor antagonist LY2409021 lowers blood glucose in healthy people and in those with type 2 diabetes. Diabetes Obes Metab. 2015 Apr;17(4):414-22. doi: 10.1111/dom.12446. Epub 2015 Mar 2.

    PMID: 25656305DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

adomeglivant

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-45 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

May 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

SG(1)