Automated Insulin + Pramlintide Delivery for Type 1 Diabetes (FCL Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?The aim of this clinical trial is to investigate whether a fully automated Lyumjev-and-pramlintide delivery system improves glycemic outcomes in adults with type 1 diabetes. The main question we aim to answer is whether a Lyumjev-pramlintide fully closed loop system improves time in range compared to a hybrid closed loop system with carbohydrate counting. We also aim to find the optimal insulin to pramlintide ratio for glycemic control in the fully automated system.
In this cross-over study, patients will undergo the following three interventions in a random order:
(i) fully automated Lyumjev insulin-and-pramlintide (8 μg/u) (ii) fully automated Lyumjev insulin-and-pramlintide (10 μg/u) (iii) rapid automated Lyumjev insulin-and-placebo with carbohydrate-matched boluses
For all interventions, participants will be required to wear two Ypsomed pumps programmed by our developed EuGlide system.
Is the Fully Automated Insulin and Pramlintide Delivery System a promising treatment for type 1 diabetes?Yes, the Fully Automated Insulin and Pramlintide Delivery System is promising because it can manage blood sugar levels without needing to count carbohydrates or input meal information, making life easier for people with type 1 diabetes.12678
What safety data is available for the automated insulin and pramlintide delivery system?The safety of pramlintide and insulin formulations has been studied in various contexts. Research includes the safety of pramlintide and insulin when mixed or given separately, the safety of a fully closed-loop system using pramlintide and faster-acting insulin aspart, and the safety of a pramlintide/insulin A21G co-formulation (ADO09). Additionally, a systematic review and meta-analysis assessed the safety of pramlintide as an adjunct to insulin therapy, and a study on adolescents found pramlintide to be well-tolerated.24689
What data supports the idea that Automated Insulin + Pramlintide Delivery for Type 1 Diabetes is an effective treatment?The available research shows that adding pramlintide to insulin therapy can improve blood sugar control and help manage body weight in people with type 1 diabetes. One study found that pramlintide lowered blood sugar spikes and was well-tolerated in adolescents. Another study highlighted that pramlintide improved blood sugar control when used with continuous insulin infusion. These findings suggest that the combination of insulin and pramlintide can be an effective treatment for managing type 1 diabetes.23458
Do I have to stop taking my current medications for the trial?The trial requires you to stop using any antihyperglycemic agents other than insulin. If you've used sodium-glucose cotransporter-2 inhibitors (SGLT2I) or Metformin in the last 2 weeks, or glucagon-like peptide-1 receptor agonists (GLP1-RA) in the last month, you cannot participate. You also cannot use glucocorticoids (except low, stable doses and inhaled steroids), medications that alter gastrointestinal motility, or hydroxyurea.
Eligibility Criteria
Adults over 18 with type 1 diabetes using insulin pump therapy for at least three months can join. They must not have had diabetic ketoacidosis or severe hypoglycemia recently, be pregnant or breastfeeding, use certain diabetes medications like SGLT2I or GLP1-RA, and should agree to effective birth control if applicable.Inclusion Criteria
I have been using an insulin pump for at least 3 months.
Exclusion Criteria
I have been hospitalized for severe low blood sugar in the last month.
I am taking medication that affects how my stomach and intestines move.
I am not on high doses of glucocorticoid medication, except for low, stable doses or inhaled steroids.
I am currently taking hydroxyurea.
I had a diabetic ketoacidosis episode within the last month.
I have been diagnosed with gastroparesis.
Treatment Details
The trial tests a fully automated system delivering insulin and pramlintide in different ratios (8 μg/u and 10 μg/u) against an automated system with insulin and placebo. The goal is to see which method keeps blood sugar levels within the target range best using two Ypsomed pumps.
3Treatment groups
Experimental Treatment
Active Control
Group I: Fully automated Lyumjev-and-pramlintide delivery system (8 μg/u)Experimental Treatment3 Interventions
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 8 μg of pramlintide.
Group II: Fully automated Lyumjev-and-pramlintide delivery system (10 μg/u)Experimental Treatment3 Interventions
Lyumjev and pramlintide fully automated delivery system with no meal announcement. Ratio of 1 unit of insulin for 10 μg of pramlintide.
Group III: Hybrid automated Lyumjev-and-placebo delivery system with carbohydrate-matched bolusesActive Control1 Intervention
Lyumjev and saline placebo hybrid automated delivery system with meal announcement. Participants must input the carbohydrate content of their meals to inform the insulin bolus doses based on their pre-programmed insulin-to-carbohydrate ratios.
Fully Automated Insulin and Pramlintide Delivery System is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Pramlintide for:
- Type 1 diabetes management when used with mealtime insulin
🇪🇺 Approved in European Union as Pramlintide for:
- Type 1 diabetes management when used with mealtime insulin
Find a clinic near you
Research locations nearbySelect from list below to view details:
Research Institute of the McGill University Health CenterMontreal, Canada
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
Juvenile Diabetes Research FoundationCollaborator
References
The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. [2019]Postprandial hyperglycemia and preprandial hypoglycemia contribute to poor glycemic control in type 1 diabetes. We hypothesized that postprandial glycemic excursions could be normalized in type 1 diabetes by suppressing glucagon with pramlintide acetate in the immediate postprandial period and supplementing glucagon in the late postprandial period. A total of 11 control subjects were compared with 8 type 1 diabetic subjects on insulin pump therapy, using the usual insulin bolus-to-carbohydrate ratio during a standard liquid meal. Type 1 diabetic subjects were then randomized to two open-labeled studies. On one occasion, type 1 diabetic subjects received a 60% increase in the insulin bolus-to-carbohydrate ratio with minidose glucagon rescue injections, and on the other occasion type 1 diabetic subjects received 30-45 microg pramlintide with their usual insulin bolus-to-carbohydrate ratio. Glucose, glucagon, amylin (pramlintide), and insulin concentrations were measured for 420 min. The plasma glucose area under the curve (AUC) for 0-420 min was lower in control versus type 1 diabetic subjects (316 +/- 5 vs. 929 +/- 18 mg x h(-1) x dl(-1), P
Properties of pramlintide and insulin upon mixing. [2019]The pharmacokinetics, pharmacodynamics, and safety of pramlintide and various insulin formulations in patients with type 1 diabetes mellitus (DM) when given as separate injections or mixed in the same syringe before injection were studied.
A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. [2022]To assess safety, efficacy, and tolerability of pramlintide dose escalation with proactive mealtime insulin reduction, followed by insulin optimization, in patients with type 1 diabetes.
Pramlintide lowered glucose excursions and was well-tolerated in adolescents with type 1 diabetes: results from a randomized, single-blind, placebo-controlled, crossover study. [2022]To evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of pramlintide in treating adolescents with type 1 diabetes.
Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy. [2022]To assess the safety and efficacy of the addition of pramlintide to continuous subcutaneous insulin infusion (CSII) therapy in patients with type 1 diabetes mellitus (T1DM).
Efficacy and safety of pramlintide injection adjunct to insulin therapy in patients with type 1 diabetes mellitus: a systematic review and meta-analysis. [2019]We aim to assess the efficacy and safety of pramlintide plus insulin therapy in patients with type 1 diabetes.
Fully Automated Artificial Pancreas for Adults With Type 1 Diabetes Using Multiple Hormones: Exploratory Experiments. [2022]A fully automated insulin-pramlintide-glucagon artificial pancreas that alleviates the burden of carbohydrate counting without degrading glycemic control was iteratively enhanced until convergence through pilot experiments on adults with type 1 diabetes.
A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomised controlled, crossover, non-inferiority trial. [2022]For people with type 1 diabetes, there is currently no automated insulin delivery system that does not require meal input. We aimed to assess the efficacy of a novel faster-acting insulin aspart (Fiasp) plus pramlintide fully closed-loop system that does not require meal input.
A co-formulation of pramlintide and insulin A21G (ADO09) improves postprandial glucose and short-term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes. [2023]Pramlintide improves postprandial glucose but requires additional injections. We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).