Diabetes Mellitus, Type 1Phase 1NCT01769404

A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes

A Phase 1 study testing LY2605541 and Insulin Glargine in people with Diabetes Mellitus, Type 1, run by Eli Lilly and Company at 1 site in Germany.

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?: LY2605541 and Insulin Glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteGermany
Study dates: Feb 2013to Dec 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 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) less than 9%
Otherwise fit and healthy
Nonsmoker

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 has poor awareness of hypoglycemia

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

Other trials in Germany

About this study

Official title: Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus

This study has 2 parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.

Conditions: 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.

LY2605541Biological
Insulin GlargineBiological

Study groups in NCT01769404
Study group	Role	What they receive
LY2605541	Experimental	Stable dose of LY2605541 (0.2 to 0.6 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen. Receives: Biological: LY2605541
Insulin Glargine	Active comparator	Stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 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.

Concentration of Epinephrine
Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.
Measured: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

Secondary outcomes (6)

Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL
The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.
Measured: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Amount of Glucose Required to Maintain BG of 72 mg/dL
The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.
Measured: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Cortisol
Cortisol levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
Measured: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Glucagon
Glucagon levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
Measured: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Growth Hormone
Growth hormone levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.
Measured: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Norepinephrine
Norepinephrine values are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.
Measured: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

Timeline

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

Feb 2013Dec 2013

First posted16 Jan 2013 (estimated)
Study startFeb 2013
Primary completionDec 2013
Study completionDec 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 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: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01769404
Sponsor's protocol ID: 14870
Other IDs: I2R-MC-BIDM
Status last verified: Mar 2019
First submitted: 14 Jan 2013
Last updated: 24 Jun 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 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01769404
Acronym / sponsor ID: 14870
Conditions: Diabetes Mellitus, Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 16 Jan 2013 (estimated)
Results: Posted 24 Jun 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
LY2605541	Experimental	Biological: LY2605541Stable dose of LY2605541 (0.2 to 0.6 units per kilogram [U/kg]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.
Insulin Glargine	Active comparator	Biological: Insulin GlargineStable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 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) less than 9%
Otherwise fit and healthy
Nonsmoker

Key exclusion criteria (2 listed)

Taking medication or supplements other than insulin to control diabetes
Suffered a hypoglycemic event in the last 12 months that required hospitalization or has poor awareness of hypoglycemia

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
LY2605541	Biological	LY2605541
Insulin Glargine	Biological	Insulin Glargine

Primary outcome

Concentration of Epinephrine
Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.

6 secondary outcomes

Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL
Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Amount of Glucose Required to Maintain BG of 72 mg/dL
Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Cortisol
Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Glucagon
Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Growth Hormone
Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp
Concentration of Norepinephrine
Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp

Results and safety

Results posted to the registry on 24 Jun 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
Cohort 1 (LY2605541, Then Insulin Glargine)	12	7
Cohort 2 (Insulin Glargine, Then LY2605541)	13	13

Primary outcome: Concentration of Epinephrine

Time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp. Mean (Standard Deviation). Unit: picomole per liter (pmol/L)

Measure	LY2605541 n = 13	Insulin Glargine n = 13
Baseline	157.2 (90.9)	196.5 (207.0)
BG nadir	607.5 (281.0)	525.2 (305.4)

Population analysed: All participants in Cohort 2 who received at least 1 dose of study drug with evaluable epinephrine data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: 0.2-0.6 U/kg LY2605541	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
Cohort 1: 0.2-0.6 U/kg Insulin Glargine	0 of 7 (0%)	3 of 7 (42.9%)	Not reported
Cohort 2: 0.2-0.6 U/kg LY2605541	0 of 13 (0%)	1 of 13 (7.7%)	Not reported
Cohort 2: 0.2-0.6 U/kg Insulin Glargine	0 of 13 (0%)	3 of 13 (23.1%)	Not reported

Limitations and caveats (from the sponsor): As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 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 LY2605541 and Insulin Glargine 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 3 inclusion and 2 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 24 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 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. 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 24 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?

Concentration of Epinephrine (time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp). 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 NCT01769404.

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 24 Jun 2019.