Type1 Diabetes MellitusPhase 1NCT04972175
Safety and Efficacy of BC LisPram
A Phase 1 study testing 50-Hour Intervention - Rapid Insulin lispro and 50-Hour Intervention - BC LisPram in people with Type1 Diabetes Mellitus, run by Michael Tsoukas at 1 site in Canada.
Trial summary
This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- 50-Hour Intervention - Rapid Insulin lispro and 50-Hour Intervention - BC LisPram
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jul 2021to Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Insulin pump therapy for at least 3 months, with daily insulin needs ranging between 30 and 80 U.
- Most recent HbA1c ≤ 9.5% (over the last two months).
- Effective birth control in female participants of childbearing potential. Medically acceptable contraception methods include condom, pills, and intrauterine device.
Who cannot join
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc....).
- Current use of glucocorticoid medication.
- Use of medication that alters gastrointestinal motility.
- Planned or ongoing pregnancy.
- Breastfeeding individuals
- Severe hypoglycemic episode within one month of admission.
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- Severe diabetic ketoacidosis episode within one month of admission.
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Known hypersensitivity to any of the study drugs or their excipients.
- Allergy to paracetamol (acetaminophen).
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Clinically abnormal significant values for haemato, biochemistry, or urinalysis screening test as judged by the Principle Investigator for underlying disease.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hygea Medical Clinic
Montreal, Quebec, H4A3T2
Louise Ullyatt, 5149380995, louise@cmhygea.com
About this study
Official title: A Randomized Controlled Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics, and Closed-loop Efficacy of BC LisPram Compared to Rapid Insulin in Pump-treated Adults With Type 1 Diabetes
This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery.
Read the detailed description
Subjects will be randomized to intervention sequences. The first 6 participants will be randomly allocated to a sequence of three treatments composed of (i) treatment with active comparator insulin lispro, (ii) treatment with BC LisPram, and (iii) treatment with BC LisPram (dual wave bolus). The following 10 participants will be randomly allocated to a sequence of either two or three treatments. Each treatment period will last 50 hours. PK/PD assessment will be performed under an open-loop system and will be followed by a 24 hour of closed-loop assessment.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- 50-Hour Intervention - Rapid Insulin lispro, 50-Hour Intervention - BC LisPram
- Keywords
- Pramlintide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50-Hour Intervention - Rapid Insulin lisproDrug
Subcutaneous-delivery of insulin lispro using pump therapy.
50-Hour Intervention - BC LisPramDrug
Subcutaneous-delivery of BC LisPram using pump therapy.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Insulin lispro - Conventional bolus | Active comparator | Participants will use subcutaneously-delivered rapid insulin (lispro) through pump therapy. Receives: Drug: 50-Hour Intervention - Rapid Insulin lispro |
| BC LisPram - Conventional bolus | Experimental | Participants will use subcutaneously-delivered BC LisPram through pump therapy. Receives: Drug: 50-Hour Intervention - BC LisPram |
| BC LisPram - Dual wave bolus | Experimental | Participants will use subcutaneously-delivered BC LisPram through pump therapy. During dual wave bolusing, 50% of the prandial bolus is delivered immediately, and the other 50% delivered over the next 30 minutes. Receives: Drug: 50-Hour Intervention - BC LisPram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Pramlintide
Area under the pramlintide concentration-time curve
Measured: Breakfast, lunch, dinner from 0 to 4 hours
Pharmacokinetics of Insulin
Area under the insulin concentration-time curve
Measured: Breakfast, lunch, dinner from 0 to 4 hours
Pharmacokinetics of Paracetamol
Area under the paracetamol concentration-time curve
Measured: Breakfast and dinner from 0 to 4 hours
Glucose Pharmacodynamics
Area under the sensor glucose concentration-time curve
Measured: Breakfast, lunch and dinner from 0 to 4 hours
Glucagon Pharmacodynamics
Area under the plasma glucagon concentration-time curve
Measured: Breakfast and dinner from 0 to 4 hours
Hypoglycaemic episodes
Number of hypoglycaemic episodes during the 0 to 50 hour period.
Measured: 0 to 50 hours
Gastrointestinal symptoms
Frequency of gastrointestinal symptoms during the 0 to 50 hour period.
Measured: 0 to 50 hours
Local tolerability at pump injection site
Local tolerability at pump injection site during the 0 to 50 hour period.
Measured: 0 to 50 hours
Incidence of adverse event
Number of adverse events during the 0 to 50 hour period.
Measured: 0 to 50 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start28 Jul 2021
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Tsoukas
- Sponsor type
- Research network
- Collaborators
- Adocia
- Responsible party
- Sponsor-investigator, Michael Tsoukas, Applied Medical Informatics Research Inc.
- Investigators
- Michael Tsoukas, MD, Principal investigator, Applied Medical Informatics Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972175
- Sponsor's protocol ID
- 2021-00050920
- Other IDs
- Pro00050920
- Status last verified
- Feb 2022
- First submitted
- 15 Jul 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics, and Closed-loop Efficacy of BC LisPram Compared to Rapid Insulin in Pump-treated Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04972175
- Acronym / sponsor ID
- 2021-00050920
- Conditions
- Type1 Diabetes Mellitus
- Keywords
- Pramlintide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Michael TsoukasResearch network
- Collaborators
- Adocia
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery.
Detailed description
Subjects will be randomized to intervention sequences. The first 6 participants will be randomly allocated to a sequence of three treatments composed of (i) treatment with active comparator insulin lispro, (ii) treatment with BC LisPram, and (iii) treatment with BC LisPram (dual wave bolus). The following 10 participants will be randomly allocated to a sequence of either two or three treatments. Each treatment period will last 50 hours. PK/PD assessment will be performed under an open-loop system and will be followed by a 24 hour of closed-loop assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rapid Insulin lispro - Conventional bolus | Active comparator | Drug: 50-Hour Intervention - Rapid Insulin lisproParticipants will use subcutaneously-delivered rapid insulin (lispro) through pump therapy. |
| BC LisPram - Conventional bolus | Experimental | Drug: 50-Hour Intervention - BC LisPramParticipants will use subcutaneously-delivered BC LisPram through pump therapy. |
| BC LisPram - Dual wave bolus | Experimental | Drug: 50-Hour Intervention - BC LisPramParticipants will use subcutaneously-delivered BC LisPram through pump therapy. During dual wave bolusing, 50% of the prandial bolus is delivered immediately, and the other 50% delivered over the next 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 18 years of age.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Insulin pump therapy for at least 3 months, with daily insulin needs ranging between 30 and 80 U.
- Most recent HbA1c ≤ 9.5% (over the last two months).
- Effective birth control in female participants of childbearing potential. Medically acceptable contraception methods include condom, pills, and intrauterine device.
Key exclusion criteria (14 listed)
- Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc....).
- Current use of glucocorticoid medication.
- Use of medication that alters gastrointestinal motility.
- Planned or ongoing pregnancy.
- Breastfeeding individuals
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 |
|---|---|---|
| 50-Hour Intervention - Rapid Insulin lisproSubcutaneous-delivery of insulin lispro using pump therapy. | Drug | Rapid Insulin lispro - Conventional bolus |
| 50-Hour Intervention - BC LisPramSubcutaneous-delivery of BC LisPram using pump therapy. | Drug | BC LisPram - Conventional bolus, BC LisPram - Dual wave bolus |
Primary outcome
Pharmacokinetics of Pramlintide
Time frame: Breakfast, lunch, dinner from 0 to 4 hours
Area under the pramlintide concentration-time curve
Pharmacokinetics of Insulin
Time frame: Breakfast, lunch, dinner from 0 to 4 hours
Area under the insulin concentration-time curve
Pharmacokinetics of Paracetamol
Time frame: Breakfast and dinner from 0 to 4 hours
Area under the paracetamol concentration-time curve
Glucose Pharmacodynamics
Time frame: Breakfast, lunch and dinner from 0 to 4 hours
Area under the sensor glucose concentration-time curve
Glucagon Pharmacodynamics
Time frame: Breakfast and dinner from 0 to 4 hours
Area under the plasma glucagon concentration-time curve
Hypoglycaemic episodes
Time frame: 0 to 50 hours
Number of hypoglycaemic episodes during the 0 to 50 hour period.
Gastrointestinal symptoms
Time frame: 0 to 50 hours
Frequency of gastrointestinal symptoms during the 0 to 50 hour period.
Local tolerability at pump injection site
Time frame: 0 to 50 hours
Local tolerability at pump injection site during the 0 to 50 hour period.
Incidence of adverse event
Time frame: 0 to 50 hours
Number of adverse events during the 0 to 50 hour period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Michael Tsoukas, MD principal investigator
Applied Medical Informatics Research Inc.
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 50-Hour Intervention - Rapid Insulin lispro and 50-Hour Intervention - BC LisPram in people with Type1 Diabetes Mellitus, run by Michael Tsoukas at 1 site in Canada.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 16 Feb 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexia Macina (+1 514-623-2520, alexia.macina@affiliate.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of Pramlintide (time frame: Breakfast, lunch, dinner from 0 to 4 hours). The study lists 9 primary outcomes in all. 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 16 Feb 2022.