Diabetes Mellitus, Type 2Phase 1NCT01995656
A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes
A Phase 1 study testing LY3108743 - Capsule and LY3108743 - Solution in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes. The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. 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?
- LY3108743 - Capsule and LY3108743 - Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2013to Apr 2014
- 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
- Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
- Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m^2), inclusive, at screening
- Have normal blood pressure
- Participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. If on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening
- Participants with diabetes must have a hemoglobin A1c (HbA1c) level between 6 to 11%, inclusive, at screening
Who cannot join
- Have previously completed or withdrawn from this study
- Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
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, 117597
About this study
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY3108743 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes.
The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.
Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant.
The study will have up to 3 parts. Participants may enroll in only one part.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo - Capsule, LY3108743 - Capsule, Placebo - Solution, LY3108743 - Solution
- 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.
Placebo - CapsuleDrug
Administered orally
LY3108743 - CapsuleDrug
Administered orally
Placebo - SolutionDrug
Administered orally
LY3108743 - SolutionDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo - Healthy | Placebo comparator | Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. Receives: Drug: Placebo - Capsule |
| LY3108743 - Healthy | Experimental | Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. Receives: Drug: LY3108743 - Capsule |
| Placebo - Diabetes | Placebo comparator | Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. Receives: Drug: Placebo - Capsule |
| LY3108743 - Diabetes | Experimental | Part B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. Receives: Drug: LY3108743 - Capsule |
| Placebo - Solution | Placebo comparator | Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods. Receives: Drug: Placebo - Solution |
| LY3108743 - Solution | Experimental | Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods. Receives: Drug: LY3108743 - Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: Pre-dose up to Day 6 (5 days post-dose)
Secondary outcomes (3)
Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal
Measured: Baseline up to 24 hours
Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743
Measured: Baseline up to 48 hours
Pharmacokinetics: Area Under the Curve (AUC) of LY3108743
Measured: Baseline up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
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
- NCT01995656
- Sponsor's protocol ID
- 15197
- Other IDs
- I7D-FW-SGAA
- Status last verified
- Jul 2014
- First submitted
- 20 Nov 2013
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY3108743 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01995656
- Acronym / sponsor ID
- 15197
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Nov 2013 (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.
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes.
The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.
Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant.
The study will have up to 3 parts. Participants may enroll in only one part.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo - Healthy | Placebo comparator | Drug: Placebo - CapsulePart A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. |
| LY3108743 - Healthy | Experimental | Drug: LY3108743 - CapsulePart A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. |
| Placebo - Diabetes | Placebo comparator | Drug: Placebo - CapsulePart B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. |
| LY3108743 - Diabetes | Experimental | Drug: LY3108743 - CapsulePart B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. |
| Placebo - Solution | Placebo comparator | Drug: Placebo - SolutionPart C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods. |
| LY3108743 - Solution | Experimental | Drug: LY3108743 - SolutionPart C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
- Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m^2), inclusive, at screening
- Have normal blood pressure
- Participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. If on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening
- Participants with diabetes must have a hemoglobin A1c (HbA1c) level between 6 to 11%, inclusive, at screening
Key exclusion criteria (2 listed)
- Have previously completed or withdrawn from this study
- Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
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 |
|---|---|---|
| Placebo - CapsuleAdministered orally | Drug | Placebo - Diabetes, Placebo - Healthy |
| LY3108743 - CapsuleAdministered orally | Drug | LY3108743 - Diabetes, LY3108743 - Healthy |
| Placebo - SolutionAdministered orally | Drug | Placebo - Solution |
| LY3108743 - SolutionAdministered orally | Drug | LY3108743 - Solution |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Pre-dose up to Day 6 (5 days post-dose)
3 secondary outcomes
Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal
Time frame: Baseline up to 24 hours
Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743
Time frame: Baseline up to 48 hours
Pharmacokinetics: Area Under the Curve (AUC) of LY3108743
Time frame: Baseline up to 48 hours
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 15 Jul 2014.
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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 LY3108743 - Capsule and LY3108743 - Solution 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 5 inclusion and 2 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 15 Jul 2014. 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Pre-dose up to Day 6 (5 days post-dose)). 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 15 Jul 2014.