Diabetes Mellitus, Type 1Phase 1NCT01771250

A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

A Phase 1 study testing Insulin Peglispro and Insulin Glargine in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in Denmark.

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 65 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Insulin Peglispro and Insulin Glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteDenmark
Study dates: Oct 2013to Dec 2014
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

Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5%
Otherwise fit and healthy
Non smoker

Who cannot join

Taking medication or supplements other than insulin to control diabetes.
Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia
Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids

Trial locations and contacts

1 site in 1 country.

Denmark1 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.
Aarhus, 8000

Other trials in Denmark

About this study

Official title: Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus

This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.

Conditions: Diabetes Mellitus, Type 1
Being tested: Insulin Peglispro, 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.

Insulin PeglisproBiological
Also called LY2605541
Daily doses administered SC.
Insulin GlargineBiological
Daily doses administered SC.

Study groups in NCT01771250
Study group	Role	What they receive
Insulin Peglispro	Experimental	Stable dose of insulin peglispro (0.2 - 0.8 units per kilogram [U/kg]) administered subcutaneously (SC) once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen. Receives: Biological: Insulin Peglispro
Insulin Glargine	Active comparator	Stable dose of insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen. Receives: Biological: Insulin Glargine

What is being measured

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

Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.
Measured: Day 22: 240 minutes (min) to 420 min
VLDL-TG Secretion Rate
VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Measured: Day 22: 240 min to 420 min
VLDL-TG Oxidation Rate
VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Measured: Day 22: 240 min to 420 min
VLDL-TG Clearance Rate
VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
Measured: Day 22: 240 min to 420 min

Timeline

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

Oct 2013Dec 2014

First posted18 Jan 2013 (estimated)
Study startOct 2013
Primary completionDec 2014
Study completionDec 2014

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01771250
Sponsor's protocol ID: 14871
Other IDs: I2R-MC-BIDN
Status last verified: Nov 2018
First submitted: 16 Jan 2013
Last updated: 11 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01771250
Acronym / sponsor ID: 14871
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 18 Jan 2013 (estimated)
Results: Posted 11 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: 2

Arm	Type	Receives
Insulin Peglispro	Experimental	Biological: Insulin PeglisproStable dose of insulin peglispro (0.2 - 0.8 units per kilogram [U/kg]) administered subcutaneously (SC) once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.
Insulin Glargine	Active comparator	Biological: Insulin GlargineStable dose of insulin glargine (0.2 - 0.8 U/kg) administered SC once daily for at least 21 days in one of two treatment periods. Dose based on prestudy basal insulin dosing regimen.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5%
Otherwise fit and healthy
Non smoker

Key exclusion criteria (3 listed)

Taking medication or supplements other than insulin to control diabetes.
Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia
Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids

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
Insulin PeglisproAlso: LY2605541Daily doses administered SC.	Biological	Insulin Peglispro
Insulin GlargineDaily doses administered SC.	Biological	Insulin Glargine

Primary outcome

Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
Time frame: Day 22: 240 minutes (min) to 420 min
VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.
VLDL-TG Secretion Rate
Time frame: Day 22: 240 min to 420 min
VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
VLDL-TG Oxidation Rate
Time frame: Day 22: 240 min to 420 min
VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.
VLDL-TG Clearance Rate
Time frame: Day 22: 240 min to 420 min
VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.

Results and safety

Results posted to the registry on 11 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
Insulin Peglispro (LY2605541) Then Insulin Glargine	8	7
Insulin Glargine Then Insulin Peglispro	7	7

Primary outcome: Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations

Time frame: Day 22: 240 minutes (min) to 420 min. Geometric mean (Geometric Coefficient of Variation). Unit: micromole per Liter (μmol/L)

Measure	Insulin Peglispro n = 14	Insulin Glargine n = 14
Value	0.27 (55)	0.17 (66)

Population analysed: All participants who were randomized and received at least one dose of study drug.

Primary outcome: VLDL-TG Secretion Rate

Time frame: Day 22: 240 min to 420 min. Geometric mean (Geometric Coefficient of Variation). Unit: μmol/min

Measure	Insulin Peglispro n = 14	Insulin Glargine n = 14
Value	38.79 (42)	25.61 (58)

Population analysed: All participants who were randomized and took at least one dose of study drug.

Primary outcome: VLDL-TG Oxidation Rate

Time frame: Day 22: 240 min to 420 min. Geometric mean (Geometric Coefficient of Variation). Unit: μmol/min

Measure	Insulin Peglispro n = 14	Insulin Glargine n = 14
Value	20.13 (40)	15.34 (59)

Population analysed: All participants who were randomized and received at least one dose of study drug.

Primary outcome: VLDL-TG Clearance Rate

Time frame: Day 22: 240 min to 420 min. Geometric mean (Geometric Coefficient of Variation). Unit: milliliters per minute (mL/min)

Measure	Insulin Peglispro n = 14	Insulin Glargine n = 14
Value	142.16 (47)	155.11 (49)

Population analysed: All participants who were randomized and received at least one dose of study drug.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Peglispro	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
Insulin Glargine	1 of 14 (7.1%)	5 of 14 (35.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 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 Insulin Peglispro and Insulin Glargine in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in Denmark.

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 3 inclusion and 3 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 11 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 Denmark. 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 11 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?

Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations (time frame: Day 22: 240 minutes (min) to 420 min). The study lists 4 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 NCT01771250.

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 11 Mar 2019.