Diabetes Mellitus, Type 1Phase 1NCT01640834
Study of LY2409021 in Participants With Type 1 Diabetes
A Phase 1 study testing LY2409021 and Glucagon in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in Germany.
Trial summary
This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- LY2409021 and Glucagon
- 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
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Sep 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight
- Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening
- Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m^2)
- Have given written informed consent approved by Lilly
Who cannot join
- Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening
- Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness
- Are pregnant or intend to become pregnant during the course of the study
- Women who are breastfeeding
- Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening
- Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.65 millimoles per liter [mmol/L])
Show all 10Show fewer
- Have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase [ALT] or aspartate transaminase [AST] greater than 2 times the upper limit of normal at screening)
- Have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine >2.0 mg/dL (177 micromoles per liter [μmol/L])
- Have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment
- Are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
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 from 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: Pilot Study of the Effects of LY2409021 in Patients With Type 1 Diabetes Mellitus
This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- LY2409021, Placebo, Glucagon
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2409021Drug
Administered orally
PlaceboDrug
Administered orally
GlucagonDrug
Administered via intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 100 mg LY2409021 | Experimental | LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.
Placebo: 2 capsules, administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3. Receives: Drug: LY2409021; Drug: Placebo; Drug: Glucagon |
| 300 mg LY2409021 | Experimental | LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3. Receives: Drug: LY2409021; Drug: Glucagon |
| Placebo | Placebo comparator | Placebo: 3 capsules administered as a single oral dose on Day 2.
Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3. Receives: Drug: Placebo; Drug: Glucagon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose
The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Measured: Baseline (Day 1), Day 2
Secondary outcomes (7)
Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin
The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Measured: Baseline (Day 1), Day 2
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
Measured: Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.
Measured: Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period
Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.
Measured: Baseline (Day 1), Day 3 up to Day 6
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia
Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.
Measured: Baseline (Day 1), Day 3 up to Day 6
Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3
The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.
Measured: Day 3
Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3
Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.
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 posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
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 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT01640834
- Sponsor's protocol ID
- 14576
- Other IDs
- I1R-MC-GLBR, 2011-006178-19
- Status last verified
- Mar 2018
- First submitted
- 12 Jul 2012
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effects of LY2409021 in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01640834
- Acronym / sponsor ID
- 14576
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Posted 29 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100 mg LY2409021 | Experimental | Drug: LY2409021, Drug: Placebo, Drug: GlucagonLY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
| 300 mg LY2409021 | Experimental | Drug: LY2409021, Drug: GlucagonLY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: GlucagonPlacebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight
- Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening
- Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m^2)
- Have given written informed consent approved by Lilly
Key exclusion criteria (10 listed)
- Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening
- Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness
- Are pregnant or intend to become pregnant during the course of the study
- Women who are breastfeeding
- Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening
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 |
|---|---|---|
| LY2409021Administered orally | Drug | 100 mg LY2409021, 300 mg LY2409021 |
| PlaceboAdministered orally | Drug | 100 mg LY2409021, Placebo |
| GlucagonAdministered via intramuscular injection | Drug | 100 mg LY2409021, 300 mg LY2409021, Placebo |
Primary outcome
Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose
Time frame: Baseline (Day 1), Day 2
The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
7 secondary outcomes
Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin
Time frame: Baseline (Day 1), Day 2
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
Time frame: Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
Time frame: Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period
Time frame: Baseline (Day 1), Day 3 up to Day 6
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia
Time frame: Baseline (Day 1), Day 3 up to Day 6
Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3
Time frame: Day 3
Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3
Time frame: Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- 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 LY2409021 and Glucagon in people with Diabetes Mellitus, Type 1, 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 4 inclusion and 10 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 29 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2018). 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?
Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose (time frame: Baseline (Day 1), Day 2). 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 29 Oct 2018.