Diabetes Mellitus, Type 2Phase 1NCT03115099
A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes
A Phase 1 study testing LY3325656, Liraglutide and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in Singapore.
Trial summary
The aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY3325656, Liraglutide and Sitagliptin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesSingapore
- Study dates
- 31 May 2017to 5 Apr 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants:
- 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 screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²)
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- For participants with Type 2 Diabetes Mellitus:
- Have diabetes controlled on diet and exercise with or without metformin for at least 30 days prior to screening, or on sulfonylureas with or without metformin
- Have a glycated hemoglobin (HbA1c) value of greater than or equal to 7% and less than or equal to 11% at screening (exercise with or without metformin)
- Have a HbA1c value of greater than or equal to 7% and less than or equal to 8.5% at screening (sulfonylureas with or without metformin)
Who cannot join
- For all participants:
- Are currently participating in another clinical study or completed one in the last 30 days
- Are allergic to LY3325656 or other related drugs
- 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 electrocardiogram (ECG) readings that are not suitable for the study
- Are infected with hepatitis B
Show all 16Show fewer
- Are infected with human immunodeficiency virus (HIV)
- Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in 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)
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- For participants with Type 2 Diabetes Mellitus:
- Have had heart disease or stroke within 6 months before entering the study
- Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
- Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
- Have used insulin to control diabetes in the last 6 months
- Show symptoms of high blood sugar e.g. frequent urination, always feeling thirsty, or unexpected weight loss
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Singapore, 117597
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Singapore
About this study
Official title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3325656 After Single Dose in Healthy Subjects and Patients With Type 2 Diabetes
The aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected.
It will also investigate how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.
The study consists of two parts. Part A will study healthy participants over approximately 12 weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks, excluding screening. Screening is required within 28 days of the start of the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY3325656, Placebo, Liraglutide, Sitagliptin
- 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.
LY3325656Drug
Administered orally
PlaceboDrug
Administered orally
LiraglutideDrug
Administered subcutaneously
SitagliptinDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Part A) | Placebo comparator | Single oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A Receives: Drug: Placebo |
| LY3325656 (Part A) | Experimental | Single ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A Receives: Drug: LY3325656 |
| Placebo (Part B) | Placebo comparator | Single oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B Receives: Drug: Placebo |
| LY3325656 (Part B) | Experimental | Single oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B Receives: Drug: LY3325656 |
| Liraglutide (Part B) | Active comparator | Single subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B Receives: Drug: Liraglutide |
| LY3325656 + Sitagliptin (Part B) | Experimental | Single oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B Receives: Drug: LY3325656; Drug: Sitagliptin |
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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively
Secondary outcomes (2)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656
Pharmacokinetics: Area Under the Concentration Curve of LY3325656 From Time Zero to 24 Hours [AUC(0-24)]
Measured: Baseline up to 72 hours after each dose of study drug
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Measured: Baseline up to 72 hours after each dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start31 May 2017
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
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
- 80 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
- NCT03115099
- Sponsor's protocol ID
- 16433
- Other IDs
- I8U-MC-DMBA
- Status last verified
- Aug 2018
- First submitted
- 11 Apr 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3325656 After Single Dose in Healthy Subjects and Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03115099
- Acronym / sponsor ID
- 16433
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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 aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected.
It will also investigate how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.
The study consists of two parts. Part A will study healthy participants over approximately 12 weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks, excluding screening. Screening is required within 28 days of the start of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo (Part A) | Placebo comparator | Drug: PlaceboSingle oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A |
| LY3325656 (Part A) | Experimental | Drug: LY3325656Single ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboSingle oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B |
| LY3325656 (Part B) | Experimental | Drug: LY3325656Single oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B |
| Liraglutide (Part B) | Active comparator | Drug: LiraglutideSingle subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B |
| LY3325656 + Sitagliptin (Part B) | Experimental | Drug: LY3325656, Drug: SitagliptinSingle oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²)
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- Have diabetes controlled on diet and exercise with or without metformin for at least 30 days prior to screening, or on sulfonylureas with or without metformin
- Have a glycated hemoglobin (HbA1c) value of greater than or equal to 7% and less than or equal to 11% at screening (exercise with or without metformin)
Key exclusion criteria (16 listed)
- Are currently participating in another clinical study or completed one in the last 30 days
- Are allergic to LY3325656 or other related drugs
- 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 electrocardiogram (ECG) readings that are not suitable for the study
- Are infected with hepatitis B
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 |
|---|---|---|
| LY3325656Administered orally | Drug | LY3325656 (Part A), LY3325656 (Part B), LY3325656 + Sitagliptin (Part B) |
| PlaceboAdministered orally | Drug | Placebo (Part A), Placebo (Part B) |
| LiraglutideAdministered subcutaneously | Drug | Liraglutide (Part B) |
| SitagliptinAdministered orally | Drug | LY3325656 + Sitagliptin (Part B) |
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: Baseline through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656
Time frame: Baseline up to 72 hours after each dose of study drug
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Time frame: Baseline up to 72 hours after each dose of study drug
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 23 Aug 2018.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3325656, Liraglutide and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites 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 8 inclusion and 16 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Baseline through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively). 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 23 Aug 2018.