Diabetes Mellitus, Type 2Phase 1NCT02942914
A Study of LY3209590 in Healthy Participants and Participants With Type 2 Diabetes
A Phase 1 study testing LY3209590 and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Germany.
Trial summary
This trial is conducted to evaluate the safety of a study drug given by injection under the skin to healthy participants and participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY3209590 and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 20 Dec 2016to 18 Oct 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all study 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 for at least 1 year
- Male participants with female partners who can become pregnant must agree to use an effective method of birth control during the study and for 4 months after study drug dosing
- Have a body mass index (BMI) of greater than 18.5 kilogram per square meter (kg/m²) and less than or equal to 35 kg/m² at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- Have venous access sufficient to allow blood sampling
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- For participants with Type 2 Diabetes Mellitus (T2DM):
- Have T2DM controlled with diet and exercise alone or are stable on metformin for at least 30 days
- If taken, prescription medications for medical conditions (e.g.antihypertensive agents, aspirin or lipid lowering agents) are stable for at least 4 weeks
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.0% and less than or equal to 9.5%
Who cannot join
- For all study participants:
- Are currently participating in another clinical study
- Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- 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
- Have donated blood or have had a loss of 500 milliliters (mL) or more in the last 3 months or have had any blood donation within the last month from screening
- Intend to start any new over-the-counter or prescription medications 7 and 14 days before planned dosing
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- For participants with T2DM:
- Have taken any glucose-lowering medications, other than metformin, including insulin, in the past 3 months before screening
- Have had more than 1 episode of severe hypoglycemia, within 6 months before entry into the study, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- Have had a blood transfusion or severe blood loss in the past 3 months, or any blood disorder that could interfere with the understanding of the results of the study
- Have received chronic (lasting greater than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and inhaled preparations) in the 3 past months, or have received any glucocorticoid therapy within 30 days before screening
Trial locations and contacts
1 site in 1 country.
Germany1 site
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.
Neuss, 41460
About this study
Official title: A First-in-Human, Ascending-Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of a Single, Subcutaneous Dose of LY3209590
This trial is conducted to evaluate the safety of a study drug given by injection under the skin to healthy participants and participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects and tolerability will be documented. This study is approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY3209590, Placebo, Insulin Glargine
- 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.
LY3209590Drug
Administered SC
PlaceboDrug
Administered SC
Insulin GlargineDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3209590 | Experimental | LY3209590 administered subcutaneously (SC). Receives: Drug: LY3209590 |
| Placebo | Placebo comparator | Placebo (sterile saline) administered SC. Receives: Drug: Placebo |
| Insulin Glargine (Lantus) | Active comparator | Insulin Glargine administered SC. Receives: Drug: Insulin Glargine |
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: Baseline through Day 31
Secondary outcomes (2)
Pharmacokinetics: Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) of LY3209590
Measured: Baseline through Day 31
Pharmacodynamics: Average Glucose from 8-Point Glucose Profiles in Participants with T2DM treated with Placebo or LY3209590
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start20 Dec 2016
- Primary completion18 Oct 2017
- Study completion18 Oct 2017
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
- Parallel groups
- 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
- NCT02942914
- Sponsor's protocol ID
- 16129
- Other IDs
- I8H-MC-BDCA, 2016-001048-20, 2016
- Status last verified
- Nov 2017
- First submitted
- 21 Oct 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Ascending-Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of a Single, Subcutaneous Dose of LY3209590
- ClinicalTrials.gov ID
- NCT02942914
- Acronym / sponsor ID
- 16129
- 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
- 20 Dec 2016 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 24 Oct 2016 (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 trial is conducted to evaluate the safety of a study drug given by injection under the skin to healthy participants and participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects and tolerability will be documented. This study is approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3209590 | Experimental | Drug: LY3209590LY3209590 administered subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (sterile saline) administered SC. |
| Insulin Glargine (Lantus) | Active comparator | Drug: Insulin GlargineInsulin Glargine administered SC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 for at least 1 year
- Male participants with female partners who can become pregnant must agree to use an effective method of birth control during the study and for 4 months after study drug dosing
- Have a body mass index (BMI) of greater than 18.5 kilogram per square meter (kg/m²) and less than or equal to 35 kg/m² at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- Have venous access sufficient to allow blood sampling
Key exclusion criteria (11 listed)
- Are currently participating in another clinical study
- Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- 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
- Have donated blood or have had a loss of 500 milliliters (mL) or more in the last 3 months or have had any blood donation within the last month from screening
- Intend to start any new over-the-counter or prescription medications 7 and 14 days before planned dosing
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 |
|---|---|---|
| LY3209590Administered SC | Drug | LY3209590 |
| PlaceboAdministered SC | Drug | Placebo |
| Insulin GlargineAdministered SC | Drug | Insulin Glargine (Lantus) |
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 Day 31
2 secondary outcomes
Pharmacokinetics: Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) of LY3209590
Time frame: Baseline through Day 31
Pharmacodynamics: Average Glucose from 8-Point Glucose Profiles in Participants with T2DM treated with Placebo or LY3209590
Time frame: Day 3
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 7 Nov 2017.
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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 LY3209590 and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Germany.
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 10 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 7 Nov 2017. 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 Germany. 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 Day 31). 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 7 Nov 2017.