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NCT04972175
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
Phase 1 trial testing 50-Hour Intervention - Rapid Insulin lispro in Type1 Diabetes Mellitus in 16 participants. Status unknown.
1 June 2022
Quick facts
| Lead sponsor | Michael Tsoukas |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 28 July 2021 |
| Primary completion | 1 June 2022 |
| Estimated completion | 1 June 2022 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- 50-Hour Intervention - Rapid Insulin lispro — full drug profile →
- 50-Hour Intervention - BC LisPram — full drug profile →
Conditions studied
- Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →
Sponsor
Michael Tsoukas — full company profile →
Who can join
18 and older, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04972175
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type1 Diabetes Mellitus
Currently open trials in the same condition.
- NCT03945747 — MEtabolic and Renal Effects of AutoMAted Insulin Delivery Systems in Youth With Type 1 Diabetes Mellitus · active not recruiting
- NCT03369821 — EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study) · recruiting
- NCT03811470 — China Diabetes Registry by Metabolic Management Center · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04972175 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Michael Tsoukas
- Last refreshed: 14 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04972175.