Diabetes Mellitus, Type 2Phase 1NCT01746017
A Study of LY2922470 in Healthy Participants and Participants With Diabetes
A Phase 1 study testing LY2922470 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The aim of this trial is to evaluate the safety of the study drug in healthy participant and participant with diabetes. It will investigate 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 also be collected. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY2922470
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2012to Mar 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- 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 18.0 kilograms per square meter (kg/m^2)
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- For participants with Type 2 Diabetes Mellitus (T2DM):
- Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening.
- Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening
Who cannot join
- For all participants:
- Are currently participating in another clinical study or completed one in the last 30 days
- Are allergic to LY2922470 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 milliliter (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 T2DM:
- 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 1 year
- Show symptoms of high blood sugar, for example (e.g.), frequent urination, always feeling thirsty, or unexpected weight loss
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: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922470 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
The aim of this trial is to evaluate the safety of the study drug in healthy participant and participant with diabetes. It will investigate 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 also be collected.
The study consists of two parts. Part A will study healthy participants in up to 4 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 5 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, LY2922470
- 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 as capsules
LY2922470Drug
Administered orally as capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Part A) | Placebo comparator | Single oral dose of placebo administered to healthy participants in up to 1 of 4 study periods in Part A Receives: Drug: Placebo |
| LY2922470 (Part A) | Experimental | Single ascending dose of LY2922470 [starting at 1 milligram (mg)] administered orally to healthy participants in up to 3 of 4 study periods in Part A Receives: Drug: LY2922470 |
| Placebo (Part B) | Placebo comparator | Single oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B Receives: Drug: Placebo |
| LY2922470 (Part B) | Experimental | Single ascending dose of LY2922470 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A Receives: Drug: LY2922470 |
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, is located in the Reported Adverse Events module.
Measured: Baseline to study completion up to 33 days
Secondary outcomes (4)
Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]
Measured: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Measured: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)]
Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Measured: Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)]
LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Measured: Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 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
- NCT01746017
- Sponsor's protocol ID
- 14796
- Other IDs
- I6K-FW-GLEA
- Status last verified
- Feb 2019
- First submitted
- 6 Dec 2012
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. 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 LY2922470 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01746017
- Acronym / sponsor ID
- 14796
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Posted 3 Jun 2019
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 the study drug in healthy participant and participant with diabetes. It will investigate 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 also be collected.
The study consists of two parts. Part A will study healthy participants in up to 4 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 5 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo (Part A) | Placebo comparator | Drug: PlaceboSingle oral dose of placebo administered to healthy participants in up to 1 of 4 study periods in Part A |
| LY2922470 (Part A) | Experimental | Drug: LY2922470Single ascending dose of LY2922470 [starting at 1 milligram (mg)] administered orally to healthy participants in up to 3 of 4 study periods in Part A |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboSingle oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B |
| LY2922470 (Part B) | Experimental | Drug: LY2922470Single ascending dose of LY2922470 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 18.0 kilograms per square meter (kg/m^2)
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening.
- Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening
Key exclusion criteria (16 listed)
- Are currently participating in another clinical study or completed one in the last 30 days
- Are allergic to LY2922470 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 |
|---|---|---|
| PlaceboAdministered orally as capsules | Drug | Placebo (Part A), Placebo (Part B) |
| LY2922470Administered orally as capsules | Drug | LY2922470 (Part A), LY2922470 (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 to study completion up to 33 days
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
4 secondary outcomes
Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]
Time frame: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
Time frame: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)]
Time frame: Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)]
Time frame: Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 LY2922470 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 7 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 3 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 to study completion up to 33 days). 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 3 Jun 2019.