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Insulin Analog

BC LisPram - Dual wave bolus for Type 1 Diabetes

Phase 1
Waitlist Available
Led By Michael Tsoukas, MD
Research Sponsored by Michael Tsoukas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 50 hours
Awards & highlights

Study 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.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 50 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 50 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gastrointestinal symptoms
Glucagon Pharmacodynamics
Glucose Pharmacodynamics
+6 more

Side effects data

From 2016 Phase 3 trial • 577 Patients • NCT01621178
37%
Blood creatinine increased
16%
Diarrhoea
14%
Nausea
11%
Glomerular filtration rate decreased
8%
Vomiting
8%
Influenza
7%
Upper respiratory tract infection
7%
Hypertension
6%
Oedema peripheral
6%
Dizziness
5%
Constipation
5%
Nasopharyngitis
5%
Urinary tract infection
5%
Weight increased
4%
Hyperkalaemia
4%
Back pain
4%
Cough
3%
Hypoglycaemia
3%
Acute kidney injury
3%
Acute myocardial infarction
3%
Decreased appetite
2%
Sinusitis
2%
Pneumonia
2%
Anaemia
1%
Dehydration
1%
Non-cardiac chest pain
1%
Drug hypersensitivity
1%
Pyrexia
1%
Cholecystitis acute
1%
Portal vein thrombosis
1%
Postpericardiotomy syndrome
1%
Renal injury
1%
Clostridium difficile colitis
1%
Gastroenteritis
1%
Gastroenteritis viral
1%
Groin abscess
1%
Osteomyelitis
1%
Pneumonia haemophilus
1%
Tracheobronchitis
1%
Toxicity to various agents
1%
Rhabdomyolysis
1%
Musculoskeletal chest pain
1%
Cardiac failure
1%
Cardiac failure acute
1%
Cardiac failure congestive
1%
Coronary artery disease
1%
Ischaemic cardiomyopathy
1%
Myocardial infarction
1%
Abdominal abscess
1%
Appendicitis
1%
Gastric cancer
1%
Carotid artery stenosis
1%
Cerebrovascular accident
1%
Cervical radiculopathy
1%
Iiird nerve paralysis
1%
Ischaemic stroke
1%
Sciatica
1%
Syncope
1%
Aspiration
1%
Hypertensive crisis
1%
Visual acuity reduced
1%
Peripheral vascular disorder
1%
Acute coronary syndrome
1%
Angina unstable
1%
Abdominal pain lower
1%
Gastritis
1%
Gastrointestinal haemorrhage
1%
Death
1%
Haemoglobin decreased
1%
Fluid retention
1%
End stage renal disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dulaglutide 0.75 mg
Insulin Glargine
Dulaglutide 1.5 mg

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: BC LisPram - Dual wave bolusExperimental Treatment1 Intervention
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.
Group II: BC LisPram - Conventional bolusExperimental Treatment1 Intervention
Participants will use subcutaneously-delivered BC LisPram through pump therapy.
Group III: Rapid Insulin lispro - Conventional bolusActive Control1 Intervention
Participants will use subcutaneously-delivered rapid insulin (lispro) through pump therapy.

Find a Location

Who is running the clinical trial?

Michael TsoukasLead Sponsor
AdociaIndustry Sponsor
28 Previous Clinical Trials
1,388 Total Patients Enrolled
Michael Tsoukas, MDPrincipal InvestigatorApplied Medical Informatics Research Inc.
4 Previous Clinical Trials
134 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of BC LisPram
Michael Tsoukas 2021. "Safety and Efficacy of BC LisPram". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04972175.
~4 spots leftby Apr 2025
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