Healthy VolunteersPhase 1NCT01606423
The Effect of LY2409021 on Blood Sugar Levels When Glucagon Levels Are Increased in Healthy Male Participants
A Phase 1 study testing LY2409021 in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
This is a study to measure the effect that various doses of LY2409021 have on blood sugar levels and on the amount of glucose released by the liver, when glucagon is given to increase these. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- 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
- 21 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2007to Mar 2008
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be a healthy male
- Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m^2 inclusive
- Have a fasting blood glucose between 3.0-6.0 millimoles/liter (mmol/L) (inclusive) at screening
Who cannot join
- Are allergic to LY2409021, insulin, glucagon, somatostatin, or similar drugs
- Have a regular alcohol intake greater than 21 units/week, 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)
- Are currently smokers or have used tobacco products on a regular basis in the 6 months prior to screening
- Have received any medication known to affect glucose metabolism in the 1 month before the study
- Have a significant blood disorder and/or donated blood (450 mL or more) in the last 3 months
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
About this study
Official title: The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects
This is a study to measure the effect that various doses of LY2409021 have on blood sugar levels and on the amount of glucose released by the liver, when glucagon is given to increase these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study periods, with a minimum 13-day washout between dosing periods. This study is approximately 9 weeks long, not including screening. A screening appointment is required within 6 weeks prior to the start of the study.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, LY2409021
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Administered orally, single dose
LY2409021Drug
Administered orally, single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Administered once, orally Receives: Drug: Placebo |
| 10 mg LY2409021 | Experimental | 10 mg LY2409021 administered once, orally Receives: Drug: LY2409021 |
| 22.5 mg LY2409021 | Experimental | 22.5 mg LY2409021 administered once, orally Receives: Drug: LY2409021 |
| 60 mg LY2409021 | Experimental | 60 mg LY2409021 administered once, orally Receives: Drug: LY2409021 |
| 200 mg LY2409021 | Experimental | 200 mg LY2409021 administered once, orally Receives: Drug: LY2409021 |
| 500 mg LY2409021 | Experimental | 500 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.
Maximum glucose response during a 3-hour glucagon infusion
Measured: During a 3-hour glucagon infusion
Secondary outcomes (2)
Total glucose released from the liver during a 3-hour glucagon infusion
Measured: During a 3-hour glucagon infusion
Maximum glucose release from the liver during a 3-hour glucagon infusion
Measured: During a 3-hour glucagon infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startNov 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606423
- Sponsor's protocol ID
- 11165
- Other IDs
- I1R-FW-GLBC
- Status last verified
- May 2012
- First submitted
- 23 May 2012
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of LY2409021 on Blood Glucose Concentrations During Hyperglucagonaemia in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01606423
- Acronym / sponsor ID
- 11165
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to measure the effect that various doses of LY2409021 have on blood sugar levels and on the amount of glucose released by the liver, when glucagon is given to increase these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study periods, with a minimum 13-day washout between dosing periods. This study is approximately 9 weeks long, not including screening. A screening appointment is required within 6 weeks prior to the start of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAdministered once, orally |
| 10 mg LY2409021 | Experimental | Drug: LY240902110 mg LY2409021 administered once, orally |
| 22.5 mg LY2409021 | Experimental | Drug: LY240902122.5 mg LY2409021 administered once, orally |
| 60 mg LY2409021 | Experimental | Drug: LY240902160 mg LY2409021 administered once, orally |
| 200 mg LY2409021 | Experimental | Drug: LY2409021200 mg LY2409021 administered once, orally |
| 500 mg LY2409021 | Experimental | Drug: LY2409021500 mg LY2409021 administered once, orally |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be a healthy male
- Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m^2 inclusive
- Have a fasting blood glucose between 3.0-6.0 millimoles/liter (mmol/L) (inclusive) at screening
Key exclusion criteria (5 listed)
- Are allergic to LY2409021, insulin, glucagon, somatostatin, or similar drugs
- Have a regular alcohol intake greater than 21 units/week, 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)
- Are currently smokers or have used tobacco products on a regular basis in the 6 months prior to screening
- Have received any medication known to affect glucose metabolism in the 1 month before the study
- Have a significant blood disorder and/or donated blood (450 mL or more) in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAdministered orally, single dose | Drug | Placebo |
| LY2409021Administered orally, single dose | Drug | 10 mg LY2409021, 200 mg LY2409021, 22.5 mg LY2409021, 500 mg LY2409021, 60 mg LY2409021 |
Primary outcome
Maximum glucose response during a 3-hour glucagon infusion
Time frame: During a 3-hour glucagon infusion
2 secondary outcomes
Total glucose released from the liver during a 3-hour glucagon infusion
Time frame: During a 3-hour glucagon infusion
Maximum glucose release from the liver during a 3-hour glucagon infusion
Time frame: During a 3-hour glucagon infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2409021 in people with Healthy Volunteers, 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 3 inclusion and 5 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?
Maximum glucose response during a 3-hour glucagon infusion (time frame: During a 3-hour glucagon infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.