Healthy VolunteersPhase 1NCT01654380

A Study of LY2605541 Versus Insulin Glargine on Blood Sugar

A Phase 1 study testing LY2605541 and Insulin glargine in people with Healthy Volunteers and Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Diabetes Mellitus, Type 1
What is being tested?: LY2605541 and Insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Oct 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 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

All Participants
Are healthy males or participants with T1DM
Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m^2)
Healthy Participants ONLY
Are overtly healthy, as determined by medical history and physical examination
Have a fasting blood glucose <108 milligrams/deciliter (mg/dL) (6.0 millimoles/liter [mmol/L]) at screening

Show all 11Show fewer

Participants with T1DM ONLY
Have a diagnosis of T1DM for at least 1 year based on medical history
Have a screening c-peptide <0.5 nanograms/milliliter (ng/mL)
Have a hemoglobin A1c (HbA1c) of 6.0 to 9.0% at screening
Have had no episodes of severe hypoglycemia in the past 6 months

Who cannot join

All Participants
Have a hemoglobin level <12.0 grams/deciliter (g/dL)
Are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study
Healthy Participants ONLY
Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).
Participants with T1DM ONLY

Show all 10Show fewer

Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
Require a total daily insulin dose exceeding 100 units (U)
Have fasting triglycerides >400 mg/dL

Trial locations and contacts

1 site in 1 country.

United States1 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.
San Diego, California

Other trials in United States

About this study

Official title: Comparison of the Effects of LY2605541 and Insulin Glargine on Endogenous Glucose Output and Peripheral Glucose Disposal in Healthy Subjects and Patients With Type 1 Diabetes Mellitus

LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.

Conditions: Healthy Volunteers, Diabetes Mellitus, Type 1
Being tested: LY2605541, Insulin glargine
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.

LY2605541Drug
LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).
Insulin glargineOther
Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.

Study groups in NCT01654380
Study group	Role	What they receive
Part A, Cohort A; LY2605541	Experimental	Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours. All periods were separated by a minimum 6-day washout period Receives: Drug: LY2605541
Part A, Cohort A; Insulin Glargine	Active comparator	Healthy participants received insulin glargine (30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period Receives: Other: Insulin glargine
Part A, Cohort B; LY2605541	Experimental	Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours. All periods were separated by a minimum 6-day washout period. Receives: Drug: LY2605541
Part A, Cohort B; Insulin Glargine	Active comparator	Healthy participants received insulin glargine (60 mU/m^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period. Receives: Other: Insulin glargine
Part B; LY2605541	Experimental	Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period. Receives: Drug: LY2605541
Part B; Insulin Glargine	Active comparator	Participants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period. Receives: Other: Insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

Part B: Glucodynamics: Endogenous Glucose Output
The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-[last 2 hours of EGP/basal EGP])*100.
The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Measured: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
Part B: Glycodynamics: Glucose Disposal
The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR.
The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Measured: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
Part B: Glycodynamics: Maximum Rate of Glucose Disposal
The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Measured: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Oct 2013

First posted31 Jul 2012 (estimated)
Study startJul 2012
Primary completionOct 2013
Study completionOct 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 Healthy VolunteersStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01654380
Sponsor's protocol ID: 12157
Other IDs: I2R-MC-BIAV
Status last verified: Nov 2018
First submitted: 27 Jul 2012
Last updated: 8 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effects of LY2605541 and Insulin Glargine on Endogenous Glucose Output and Peripheral Glucose Disposal in Healthy Subjects and Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01654380
Acronym / sponsor ID: 12157
Conditions: Healthy Volunteers, Diabetes Mellitus, Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 31 Jul 2012 (estimated)
Results: Posted 8 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Part A, Cohort A; LY2605541	Experimental	Drug: LY2605541Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours. All periods were separated by a minimum 6-day washout period
Part A, Cohort A; Insulin Glargine	Active comparator	Other: Insulin glargineHealthy participants received insulin glargine (30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period
Part A, Cohort B; LY2605541	Experimental	Drug: LY2605541Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours. All periods were separated by a minimum 6-day washout period.
Part A, Cohort B; Insulin Glargine	Active comparator	Other: Insulin glargineHealthy participants received insulin glargine (60 mU/m^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period.
Part B; LY2605541	Experimental	Drug: LY2605541Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period.
Part B; Insulin Glargine	Active comparator	Other: Insulin glargineParticipants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

All Participants
Are healthy males or participants with T1DM
Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m^2)
Healthy Participants ONLY
Are overtly healthy, as determined by medical history and physical examination

Key exclusion criteria (10 listed)

All Participants
Have a hemoglobin level <12.0 grams/deciliter (g/dL)
Are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study
Healthy Participants ONLY
Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).

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
LY2605541LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).	Drug	Part A, Cohort A; LY2605541, Part A, Cohort B; LY2605541, Part B; LY2605541
Insulin glargineInsulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.	Other	Part A, Cohort A; Insulin Glargine, Part A, Cohort B; Insulin Glargine, Part B; Insulin Glargine

Primary outcome

Part B: Glucodynamics: Endogenous Glucose Output
Time frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-[last 2 hours of EGP/basal EGP])*100. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Part B: Glycodynamics: Glucose Disposal
Time frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Part B: Glycodynamics: Maximum Rate of Glucose Disposal
Time frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.

Results and safety

Results posted to the registry on 8 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A, Cohort A: LY2605541 First, Then Insulin Glargine	4	4
Part A, Cohort B: LY2605541 First, Then Insulin Glargine	4	4
Part B: LY2605541	0	0
Part B: Insulin Glargine	0	0

Primary outcome: Part B: Glucodynamics: Endogenous Glucose Output

Time frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp). Mean (Standard Deviation). Unit: percent of suppression

Measure	15.3 mU/Min LY2605541 n = 14	74.1 mU/Min LY2605541 n = 13	10 mU/m^2/Min Insulin Glargine n = 13	20 mU/m^2/Min Insulin Glargine n = 12
Value	64.53 (19.35)	99.23 (1.76)	78.05 (17.33)	97.05 (6.47)

Population analysed: Participants who received at least 1 dose of study drug with evaluable EGP data

Primary outcome: Part B: Glycodynamics: Glucose Disposal

Time frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp). Mean (Standard Deviation). Unit: fold change

Measure	15.3 mU/Min LY2605541 n = 14	74.1 mU/Min LY2605541 n = 13	10 mU/m^2/Min Insulin Glargine n = 13	20 mU/m^2/Min Insulin Glargine n = 12
Value	0.68 (0.09)	1.42 (0.35)	0.98 (0.39)	1.85 (0.59)

Population analysed: Participants who received at least 1 dose of study drug with evaluable GDR data.

Primary outcome: Part B: Glycodynamics: Maximum Rate of Glucose Disposal

Time frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp). Geometric mean (Geometric Coefficient of Variation). Unit: milligrams/minute/kilograms (mg/min/kg)

Measure	15.3 mU/Min LY2605541 n = 14	74.1 mU/Min LY2605541 n = 13	10 mU/m^2/Min Insulin Glargine n = 13	20 mU/m^2/Min Insulin Glargine n = 13
Value	1.80 (24)	2.89 (23)	2.15 (28)	3.55 (40)

Population analysed: Participants who received at least 1 dose of study drug with evaluable Rdmax data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A, Cohort A: 5.1 mU/Min LY2605541	0 of 4 (0%)	0 of 4 (0%)	Not reported
Part A, Cohort A: 10.2 mU/Min LY2605541	0 of 4 (0%)	2 of 4 (50%)	Not reported
Part A, Cohort A or Cohort B: 15.3 mU/Min LY2605541	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Part A, Cohort A: 30 mU/m^2/Min Insulin Glargine	0 of 4 (0%)	2 of 4 (50%)	Not reported
Part A, Cohort B: 37.0 mU/Min LY2605541	0 of 4 (0%)	1 of 4 (25%)	Not reported
Part A, Cohort B: 74.1 mU/Min LY2605541	0 of 4 (0%)	0 of 4 (0%)	Not reported
Part A, Cohort B: 20 mU/m^2/Min Insulin Glargine	0 of 4 (0%)	1 of 4 (25%)	Not reported
Part B: 15.3 mU/Min LY2605541	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
Part B: 74.1 mU/Min LY2605541	0 of 13 (0%)	3 of 13 (23.1%)	Not reported
Part B: 10 mU/m^2/Min Insulin Glargine	0 of 13 (0%)	2 of 13 (15.4%)	Not reported
Part B: 20 mU/m^2/Min Insulin Glargine	0 of 13 (0%)	5 of 13 (38.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 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 LY2605541 and Insulin glargine in people with Healthy Volunteers and Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in United States.

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 11 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 8 Mar 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 United States. 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. 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 8 Mar 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?

Part B: Glucodynamics: Endogenous Glucose Output (time frame: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01654380.

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 8 Mar 2019.