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Diabetes Mellitus, Type 2Phase 1NCT01606371

A First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes

A Phase 1 study testing LY2409021 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY2409021
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteSingapore
Study dates
May 2007to Oct 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • 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

Other trials in Singapore

About this study

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2409021 After Escalating Single Oral Dose Administration in Healthy Subjects and Patients With Type 2 Diabetes Mellitus

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.

Being tested
Placebo, LY2409021
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Administered orally

  • LY2409021Drug

    Administered orally

Study groups in NCT01606371
Study groupRoleWhat they receive
Healthy-PlaceboPlacebo comparatorPlacebo (capsule) administered once, orally
Receives: Drug: Placebo
Healthy-2.5 mg LY2409021Experimental2.5 mg LY2409021 administered once, orally
Receives: Drug: LY2409021
Healthy-10 mg LY2409021Experimental10 mg LY2409021 administered once, orally
Receives: Drug: LY2409021
Healthy-30 mg LY2409021Experimental30 mg LY2409021 administered once, orally
Receives: Drug: LY2409021
Healthy-100 mg LY2409021Experimental100 mg LY2409021 administered once, orally
Receives: Drug: LY2409021
Healthy-250 mg LY2409021Experimental250 mg LY2409021 administered once, orally
Receives: Drug: LY2409021
Healthy-500 mg LY2409021Experimental500 mg LY2409021 administered once, orally
Receives: Drug: LY2409021
Diabetic-PlaceboPlacebo comparatorPlacebo (capsule) administered once, orally
Receives: Drug: Placebo
Diabetic-75 mg LY2409021Experimental75 mg LY2409021 administered once, orally
Receives: Drug: LY2409021
Diabetic-200 mg LY2409021Experimental200 mg LY2409021 administered once, orally
Receives: Drug: LY2409021
Diabetic-500 mg LY2409021Experimental500 mg LY2409021 administered once, orally
Receives: Drug: LY2409021

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (7)

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

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

  2. Pharmacokinetics: Maximum concentration (Cmax) of LY2409021

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

  3. Change in fasting blood glucose level

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

  4. Change in fasting insulin level

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

  5. Change in fasting glucagon level

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

  6. Change in fasting glucagon-like peptide-1 (GLP-1) level

    Measured: From each dose of study drug up to 24 hours post dose

  7. Glucose excursion after meals

    Measured: 28 hours after each dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2012 (estimated)
  2. Study startMay 2007
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01606371
Sponsor's protocol ID
10837
Other IDs
I1R-FW-GLBA
Status last verified
May 2012
First submitted
23 May 2012
Last updated
25 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25656305

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2409021 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with one or more drug related adverse events (AEs) or any serious AEs (time frame: From first dose of study drug up to discharge (at least 14 days after last dose)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01606371, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2012.

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