NCT01606397

Brief Summary

The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes :

  • The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses
  • How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks
  • How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other naturally occurring substances before and after a meal
  • How LY2409021 works when given with metformin
  • How daily dosing of LY2409021 affects the cells that produce insulin

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2008

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
2 countries

2 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

Study Start

First participant enrolled

March 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
3.6 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

8 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 28 days after last dose)

Secondary Outcomes (9)

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

    From first study drug dose to Day 28 post last dose

  • Pharmacokinetics: Maximum concentration (Cmax) of LY2409021

    From first study drug dose to Day 28 post last dose

  • Change in fasting blood glucose level

    From Day -1 to Day 28 of dosing

  • Change in incremental area under the curve (AUC) for glucose

    From Day -1 to Day 28 of dosing

  • Change in homeostasis model assessment of beta cell function (HOMA-B)

    From baseline to Day 28

  • +4 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo administered orally once daily for 4 weeks

Drug: Placebo

5 mg LY2409021

EXPERIMENTAL

5 mg LY2409021 administered orally once daily for 4 weeks

Drug: LY2409021

30 mg LY2409021

EXPERIMENTAL

30 mg LY2409021 administered orally once daily for 4 weeks

Drug: LY2409021

60 mg LY2409021

EXPERIMENTAL

60 mg LY2409021 administered orally once daily for 4 weeks

Drug: LY2409021

90 mg LY2409021

EXPERIMENTAL

90 mg LY2409021 administered orally once daily for 4 weeks

Drug: LY2409021

Interventions

PlaceboDRUG

Administered orally (capsule)

Placebo
LY2409021DRUG

Administered orally (capsule)

30 mg LY24090215 mg LY240902160 mg LY240902190 mg LY2409021

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be either a male, or a female who cannot become pregnant, who has type 2 diabetes and is either controlling diabetes through diet and exercise, or taking metformin
  • Have an hemoglobin A1c (HbA1c) value at screening of greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen at the time of measurement
  • Have a screening body mass index (BMI) of 20 to 40 kg/m\^2 inclusive
  • Have a blood pressure reading at screening of between 90 to 160 millimeters of mercury (mmHg) (systolic) and 40 to 95 mmHg (diastolic)

You may not qualify if:

  • Have used insulin for diabetic control within 1 year of study entry
  • Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 1 month, prior to first planned dosing. Metformin is acceptable for this study.
  • Have clinically significant coronary artery disease
  • Have clinically significant peripheral vascular disease
  • Have clinical evidence of active diabetic proliferative retinopathy
  • Have known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis
  • Impaired renal function (serum creatinine greater than 115 micromoles/liter \[μmol/L\] \[1.3 mg/dL\] in women, greater than 130 μmol/L \[1.5 mg/dL\] in men)
  • Have triglycerides greater than 4.5 millimoles per liter (mmol/L) \[approximately 400 mg/dL\] at screening
  • Were hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
  • Are allergic to LY2409021 or similar drugs
  • Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data
  • Have used systemic glucocorticoids within 1 month prior to first dosing
  • Have donated 450 mL or more of blood in the last 3 months or have donated any blood within the last month
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

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.

Plymouth, United Kingdom

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 1-317-615-4559 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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

March 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

GB(1)SG(1)