Type 1 Diabetes MellitusPhase 1NCT05067270

A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus

A Phase 1 study testing Sodium Citrate, Treprostinil and Humalog diluent in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 2 sites in Germany.

Completed

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

Official record

Search all trials

Trial summary

The main purpose of this study is to evaluate the effect of excipients sodium citrate and treprostinil without insulin on local infusion site pain in participants with type 1 diabetes mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII). Read more about this study

Who is it for?: Ages 18 to 69 years
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: Sodium Citrate, Treprostinil and Humalog diluent
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesGermany
Study dates: 22 Oct 2021to 6 Dec 2021
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 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

T1D for at least 1 year and continuously using insulin for at least 1 year
Using an insulin pump for at least the last 6 months
Have hemoglobin A1c (HbA1c) value of ≤ 9.0%
Have a body mass index (BMI) within the range of 18.5 to 35.0 kilograms per square meter (kg/m²)
Have medical and laboratory test results that are acceptable for the study
Have venous access sufficient to allow for blood sampling

Who cannot join

Hemophilia or any other bleeding disorder
Have a pathologic tuning fork test as assessed with a Rydel-Seiffer tuning fork
Are taking anesthetics or pain medication regularly or intermittently which could interfere with interpretation of pain scale
Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the last 90 days prior to screening
Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within the last 6 months prior to screening
Have any hypersensitivity or allergy to any of the diluents or excipients used in this trial

Show all 9Show fewer

Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Have participated, within the last 30 days, in a clinical trial involving an investigational product
Have used or are currently using Lyumjev® as part of their standard insulin therapy

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Profil Mainz
Mainz, 55116
Profil Institut für Stoffwechselforschung
Neuss, North Rhine-Westphalia, 41460

Other trials in Germany

About this study

Official title: A Study to Investigate Local Infusion Site Pain After Infusion of Excipients Across Infusion Sites and Infusion Depths

Conditions: Type 1 Diabetes Mellitus
Being tested: Sodium Citrate, Treprostinil, Humalog diluent, Magnesium Chloride
Keywords: Humalog - Insulin lispro, Citrate, Infusion Site Pain, Excipients
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.

Sodium CitrateDrug
Administered SC infusion.
TreprostinilDrug
Administered SC infusion.
Humalog diluentDrug
Administered SC infusion.
Magnesium ChlorideDrug
Administered SC infusion.

Study groups in NCT05067270
Study group	Role	What they receive
Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh	Experimental	Participants had cannulas inserted into each of the designated infusion sites (6 millimeter (mm) for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated subcutaneously (SC) with 15 millimolar (mM) sodium citrate and 1 microgram per milliliter (μg/mL) treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 unit per hour (U/h). The same procedure occurred at subsequent infusion sites with an approximately 30-minute (min) interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites. Receives: Drug: Sodium Citrate; Drug: Treprostinil; Drug: Humalog diluent; Drug: Magnesium Chloride
Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock	Experimental	Participants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites. Receives: Drug: Sodium Citrate; Drug: Treprostinil; Drug: Humalog diluent; Drug: Magnesium Chloride
Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region	Experimental	Participants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites. Receives: Drug: Sodium Citrate; Drug: Treprostinil; Drug: Humalog diluent; Drug: Magnesium Chloride
Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm	Experimental	Participants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 units per U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites. Receives: Drug: Sodium Citrate; Drug: Treprostinil; Drug: Humalog diluent; Drug: Magnesium Chloride
Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm	Experimental	Participants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites. Receives: Drug: Sodium Citrate; Drug: Treprostinil; Drug: Humalog diluent; Drug: Magnesium Chloride

What is being measured

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

Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).
Measured: Day 1: 1 min post bolus.

Timeline

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

22 Oct 20216 Dec 2021

First posted5 Oct 2021
Study start22 Oct 2021
Primary completion6 Dec 2021
Study completion6 Dec 2021

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05067270
Sponsor's protocol ID: 18278
Other IDs: I8B-MC-ITTC, 2021-001987-18
Status last verified: Dec 2022
First submitted: 28 Sep 2021
Last updated: 4 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ignaut D, Fukuda T, Bandi R, Ermer M, Stoffel MS, Zijlstra E, Paavola C. An Investigation Into Local Infusion Site Pain After Infusion of Ultra Rapid Lispro Excipients Across Sites and Depths. J Diabetes Sci Technol. 2024 Jul;18(4):920-929. doi: 10.1177/19322968221135217. Epub 2022 Nov 3.
PubMed 36326260

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

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate Local Infusion Site Pain After Infusion of Excipients Across Infusion Sites and Infusion Depths
ClinicalTrials.gov ID: NCT05067270
Acronym / sponsor ID: 18278
Conditions: Type 1 Diabetes Mellitus
Keywords: Humalog - Insulin lispro, Citrate, Infusion Site Pain, Excipients
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 22 Oct 2021 (actual)
Primary completion: 6 Dec 2021 (actual)
Study completion: 6 Dec 2021 (actual)
First posted: 5 Oct 2021 (actual)
Results: Posted 4 Oct 2023

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh	Experimental	Drug: Sodium Citrate, Drug: Treprostinil, Drug: Humalog diluent, Drug: Magnesium ChlorideParticipants had cannulas inserted into each of the designated infusion sites (6 millimeter (mm) for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated subcutaneously (SC) with 15 millimolar (mM) sodium citrate and 1 microgram per milliliter (μg/mL) treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 unit per hour (U/h). The same procedure occurred at subsequent infusion sites with an approximately 30-minute (min) interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock	Experimental	Drug: Sodium Citrate, Drug: Treprostinil, Drug: Humalog diluent, Drug: Magnesium ChlorideParticipants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region	Experimental	Drug: Sodium Citrate, Drug: Treprostinil, Drug: Humalog diluent, Drug: Magnesium ChlorideParticipants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm	Experimental	Drug: Sodium Citrate, Drug: Treprostinil, Drug: Humalog diluent, Drug: Magnesium ChlorideParticipants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 units per U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm	Experimental	Drug: Sodium Citrate, Drug: Treprostinil, Drug: Humalog diluent, Drug: Magnesium ChlorideParticipants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.

Who may qualify

Ages: 18 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

T1D for at least 1 year and continuously using insulin for at least 1 year
Using an insulin pump for at least the last 6 months
Have hemoglobin A1c (HbA1c) value of ≤ 9.0%
Have a body mass index (BMI) within the range of 18.5 to 35.0 kilograms per square meter (kg/m²)
Have medical and laboratory test results that are acceptable for the study

Key exclusion criteria (9 listed)

Hemophilia or any other bleeding disorder
Have a pathologic tuning fork test as assessed with a Rydel-Seiffer tuning fork
Are taking anesthetics or pain medication regularly or intermittently which could interfere with interpretation of pain scale
Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the last 90 days prior to screening
Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within the last 6 months prior to 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
Sodium CitrateAdministered SC infusion.	Drug	Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh, Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock, Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region, Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm, Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
TreprostinilAdministered SC infusion.	Drug	Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh, Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock, Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region, Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm, Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
Humalog diluentAdministered SC infusion.	Drug	Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh, Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock, Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region, Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm, Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
Magnesium ChlorideAdministered SC infusion.	Drug	Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh, Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock, Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region, Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm, Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm

Primary outcome

Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
Time frame: Day 1: 1 min post bolus.
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).

Results and safety

Results posted to the registry on 4 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh	8	8
Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock	8	8
Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region	8	8
Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm	8	8
Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm	8	8

Primary outcome: Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas

Time frame: Day 1: 1 min post bolus.. Geometric mean (Geometric Coefficient of Variation). Unit: millimeter

Measure	Treatment Given to Arm Region n = 38	Treatment Given to Thigh n = 37	Treatment Given to Abdomen (6 mm) n = 39	Treatment Given to Abdomen (9 mm) n = 40	Treatment Given to Buttock n = 39
1 min post bolus (Bolus time: 3 hours)	3.4 (182)	2.0 (119)	1.8 (112)	1.9 (119)	2.4 (167)
1 min post bolus (Bolus time: 6 hours)	3.7 (164)	2.6 (137)	2.3 (151)	2.0 (113)	3.3 (161)
1 min post bolus (Bolus time: 9 hours)	4.8 (211)	3.4 (155)	2.5 (141)	2.4 (141)	3.8 (196)

Treatment Given to Arm Region vs Treatment Given to Thigh: Geometric Least Squares Mean Ratio: 1.77 (95% CI 1.30 to 2.40)
Treatment Given to Arm Region vs Treatment Given to Abdomen (6 mm): Geometric Least Squares Mean Ratio: 1.91 (95% CI 1.42 to 2.59)
Treatment Given to Arm Region vs Treatment Given to Abdomen (9 mm): Geometric Least Squares Mean Ratio: 1.84 (95% CI 1.37 to 2.49)

Population analysed: All participants who received at least one infusion and had VAS pain scores.

Adverse events

Time frame: Up to 9 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Given to Arm Region	0 of 40 (0%)	5 of 40 (12.5%)	0 of 40
Treatment Given to Thigh	0 of 40 (0%)	9 of 40 (22.5%)	0 of 40
Treatment Given to Abdomen (6 mm)	0 of 40 (0%)	4 of 40 (10%)	0 of 40
Treatment Given to Abdomen (9 mm)	0 of 40 (0%)	4 of 40 (10%)	0 of 40
Treatment Given to Buttock	0 of 40 (0%)	3 of 40 (7.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36326260Ignaut D, Fukuda T, Bandi R, Ermer M, Stoffel MS, Zijlstra E, Paavola C. An Investigation Into Local Infusion Site Pain After Infusion of Ultra Rapid Lispro Excipients Across Sites and Depths. J Diabetes Sci Technol. 2024 Jul;18(4):920-929. doi: 10.1177/19322968221135217. Epub 2022 Nov 3.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes Mellitus

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sodium Citrate, Treprostinil and Humalog diluent in people with Type 1 Diabetes Mellitus, run by Eli Lilly and Company at 2 sites 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 6 inclusion and 9 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 4 Oct 2023). 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?

Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas (time frame: Day 1: 1 min post bolus.). 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 NCT05067270, which also lists 1 linked publication.

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 4 Oct 2023.