Trial · Interventional

CompletedPhase 2Registry data

Effect of Basal-Bolus Closed-Loop Co-Administration of Insulin and Pramlintide on Improving the Glycemic Control in Type 1 Diabetes

NCTNCT02814123Other idMAP-1

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 28 participants (actual)
Sponsor: McGill University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Canada
Start: 13 Jan 2017
Primary completion: 8 Jul 2018
Completion: 8 Jul 2018
First posted: 27 Jun 2016 (estimated)
Last update posted: 17 Feb 2020
Conditions: Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 2
Effect of Basal-Bolus Closed-Loop Co-Administration of Insulin and Pramlintide on Improving the Glycemic Control in Type 1 Diabetes
NCT02814123
13 Jan 2017 to 8 Jul 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The closed-loop delivery system is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. Pramlintide is a drug and an analog of amylin, a hormone that is co-secreted with insulin in healthy individuals, and is deficient in people with type 1 diabetes. Co-injection of pramlintide with insulin at meal times improves glucose control in type 1 diabetes. Literature data suggests that regular insulin may better match the effect of pramlintide compared to rapid insulin in regulating post-prandial glucose levels. The purpose of this study is to compare the effectiveness of 3 strategies to control your day-and-night glucose levels: 1. rapid insulin-alone closed-loop delivery; 2. rapid insulin-plus-pramlintide closed-loop delivery; 3. regular insulin-plus-pramlintide closed-loop delivery. The primary hypotheses are: 1. During closed-loop control, the simultaneous basal-bolus infusion of pramlintide and fast-acting insulin improves glucose control compared to fast-acting insulin-alone infusion. 2. During closed-loop control, the simultaneous basal-bolus infusion of pramlintide and regular insulin improves glucose control compared to fast-acting insulin-alone infusion.

Interventions

24-hour inpatient interventionOther

Arms3

Active comparator
Rapid Insulin-alone closed-loop delivery
Rapid Insulin will be delivered by subcutaneous infusion. Interventions: 24-hour inpatient intervention Drug: Rapid acting Insulin (aspart, lispro, glulisine)
Experimental
Rapid Insulin-plus-pramlintide closed-loop delivery
Rapid insulin and pramlintide will be delivered by subcutaneous infusion using a fixed ratio (6 µg pramlintide/unit insulin). Interventions: 24-hour inpatient intervention Drug: Rapid acting Insulin (aspart, lispro, glulisine) Drug: Pramlintide
Experimental
Regular Insulin-plus-pramlintide closed-loop delivery
Regular insulin and pramlintide will be delivered by subcutaneous infusion using a fixed ratio (6 µg pramlintide/unit insulin). Interventions: 24-hour inpatient intervention Drug: Regular Insulin (humulin R) Drug: Pramlintide

Primary outcomes2

Outcomes the sponsor listed as primary.

Percentage of time of plasma glucose levels spent in target range. Target range is defined to be between 3.9 and 10.0 mmol/L of fast-acting insulin-plus-pramlintide closed-loop delivery vs. fast-acting insulin-alone closed-loop delivery.
Time frame · Up to 24 hours
Percentage of time of plasma glucose levels spent in target range. Target range is defined to be between 3.9 and 10.0 mmol/L of regular insulin-plus-pramlintide closed-loop delivery vs. fast-acting insulin-alone closed-loop delivery.
Time frame · Up to 24 hours

Secondary outcomes(12)

Percentage of time of plasma glucose levels spent in target range, comparing fast-acting insulin-plus-pramlintide closed-loop delivery vs. regular insulin-plus-pramlintide closed-loop delivery.
Time frame · Up to 24 hours
Percentage of time (8:00-8:00) of plasma glucose levels spent: a. 3.9-7.8 mmol/L; b. 3.9-10 mmol/L; c. <3.9 mmol/L; d. <3.3 mmol/L; e. <2.8 mmol/L; f. >7.8 mmol/L; g. >10 mmol/L; h. >13.9 mmol/L; i. >16.7 mmol/L
Time frame · Up to 24 hours
Percentage of overnight time (23:00-8:00) of plasma glucose levels: a. 3.9-7.8 mmol/L; b. 3.9-10 mmol/L; c. <3.9 mmol/L; d. <3.3 mmol/L; e. <2.8 mmol/L; f. >7.8 mmol/L; g. >10 mmol/L; h. >13.9 mmol/L; i. >16.7 mmol/L
Time frame · Up to 24 hours
Standard deviation of glucose levels as a measure of glucose variability.
Time frame · Up to 24 hours
Total insulin delivery.
Time frame · Up to 24 hours
Total pramlintide delivery.
Time frame · Up to 24 hours
Mean plasma glucose level during: a. the overall study period; b. overnight period.
Time frame · Up to 24 hours
Mean plasma insulin concentration.
Time frame · Up to 24 hours
Mean plasma glucagon concentration.
Time frame · Up to 24 hours
Mean plasma amylin concentration.
Time frame · Up to 24 hours
Number of subjects experiencing hypoglycemia requiring oral treatment during: a. the overall study period; b. the night.
Time frame · Up to 24 hours
Gastrointestinal symptoms during the treatment optimization (i.e., the minimum 10 days prior to the 24-hour closed-loop visits) and during the 24-hour closed-loop visits.
Time frame · Up to 24 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

8 results

A Novel Dual-Hormone Insulin-and-Pramlintide Artificial Pancreas for Type 1 Diabetes: A Randomized Controlled Crossover Trial.

Haidar et al. 2020Diabetes carecited by 87

PMID 31974099DOI 10.2337/dc19-1922PUB-31974099

Full text at the publisher8 results

Publisher page See results (8)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedTsoukas M, Rutkowski J, El-Fathi A, Yale JF, Bernier-Twardy S, Bossy A, Pytka E, Legault L, Haidar A. Accuracy of FreeStyle Libre in Adults with Type 1 Diabetes: The Effect of Sensor Age. Diabetes Technol Ther. 2020 Mar;22(3):203-207. doi: 10.1089/dia.2019.0262. Epub 2020 Jan 23. PMID 31613140

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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.) * The subject will have been on insulin pump therapy for at least 6 months. * HbA1c ≤ 10%. Exclusion Criteria: * Current or ≤ 1 month use of other antihyperglycemic agents (SGLT2, GLP-1, Metformin, Acarbose, etc.…). * Severe hypoglycemic episode within one month of screening. * Severe diabetes keto-acidosis episode within one month of screening. * Planned or ongoing pregnancy. * Known or suspected allergy to the study drugs. * Gastroparesis. * Use of prokinetic drugs that stimulate gastric emptying (domperidone, cisapride, metoclopramide). * 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. * Current use of glucocorticoid medication. * Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. * Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc.).

PepBank is a research reference. Talk to a doctor before you use any peptide.