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

Haidar A, Tsoukas MA, Bernier-Twardy S, Yale JF, Rutkowski J, Bossy A, Pytka E, El Fathi A, Strauss N, Legault L

Diabetes care23 Jan 2020Cited by 87 (Europe PMC)

PMID31974099DOI10.2337/dc19-1922PepBankPUB-31974099

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, rapid insulin-and-pramlintide increased time in range versus rapid insulin alone.
In plain wordsIn adults with type 1 diabetes, rapid insulin-and-pramlintide increased time in range versus rapid insulin alone.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseTime in range with rapid insulin
Study
n: not reported in source
Comparator
Rapid insulin-alone artificial pancreas
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 hAs given in this study (human).
Measurements
Time in range (3.9-10.0 mmol/L)
84%
Rapid insulin-and-pramlintide, SD 13%, P=0.0014
Time in range (3.9-10.0 mmol/L)
74%
Rapid insulin-alone, SD 18%
Source sentences
Summary
Compared with the rapid insulin-alone artificial pancreas system, the rapid insulin-and-pramlintide system increased the time in range from 74% (SD 18%) to 84% (13%) (P = 0.0014), whereas the regular insulin-and-pramlintide system did not change the time in range (69% [19%]; P = 0.22).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes.
Report a problemFND-3197409901
02HumanRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, rapid insulin-and-pramlintide increased daytime time in range versus rapid insulin alone.
In plain wordsIn adults with type 1 diabetes, rapid insulin-and-pramlintide increased daytime time in range versus rapid insulin alone.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseDaytime time in range
Study
n: not reported in source
Comparator
Rapid insulin-alone artificial pancreas
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 hAs given in this study (human).
Measurements
Daytime time in range
78%
Rapid insulin-and-pramlintide, SD 16%, P=0.0004
Daytime time in range
63%
Rapid insulin-alone, SD 23%
Source sentences
Summary
The increased time in range with the rapid insulin-and-pramlintide system was due to improved daytime control (daytime time in range increased from 63% [23%] to 78% [16%], P = 0.0004).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes.
Report a problemFND-3197409903
03HumanRandomized controlled trialSafety outcome
In adults with type 1 diabetes, rapid insulin-and-pramlintide had 12 hypoglycemic events versus 11 with rapid insulin alone.
In plain wordsIn adults with type 1 diabetes, rapid insulin-and-pramlintide had 12 hypoglycemic events versus 11 with rapid insulin alone.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseHypoglycemic events with rapid insulin
Study
n: not reported in source
Comparator
Rapid insulin-alone artificial pancreas
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 24 hAs given in this study (human).
Measurements
Hypoglycemic events
12 events
Rapid insulin-and-pramlintide, 1 per 2.3 days
Hypoglycemic events
11 events
Rapid insulin-alone, 1 per 2.5 days
Source sentences
Summary
There were 11 (1 per 2.5 days) hypoglycemic events (<3.3 mmol/L with symptoms or <3.0 mmol/L irrespective of symptoms) with the rapid insulin-alone system, compared with 12 (1 per 2.3 days) and 18 (1 per 1.4 days) with the rapid and regular insulin-and-pramlintide systems, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes.
Report a problemFND-3197409904
04HumanRandomized controlled trialSafety outcome
In adults with type 1 diabetes, gastrointestinal symptoms followed 6% of meals with rapid insulin-and-pramlintide versus 0% with rapid insulin alone.
In plain wordsGastrointestinal symptoms followed 6% of meals with rapid insulin-and-pramlintide versus 0% with rapid insulin alone in adults with type 1 diabetes.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseGastrointestinal symptoms with rapid insulin
Study
n: not reported in source
Comparator
Rapid insulin-alone artificial pancreas
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · 24 hAs given in this study (human).
Measurements
Meals followed by gastrointestinal symptoms
6%
Rapid insulin-and-pramlintide, 6 of 108 meals
Meals followed by gastrointestinal symptoms
0%
Rapid insulin-alone, 0 of 112 meals
Source sentences
Summary
Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes.
Report a problemFND-3197409906

Studies that did not test the peptide alone4

In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Pramlintide (Symlin).

05HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, regular insulin-and-pramlintide did not change time in range versus rapid insulin alone.
In plain wordsIn adults with type 1 diabetes, regular insulin-and-pramlintide did not change time in range versus rapid insulin alone.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeTime in range with regular insulin
Study
n: not reported in source
Comparator
Rapid insulin-alone artificial pancreas
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Time in range (3.9-10.0 mmol/L)
69%
Regular insulin-and-pramlintide, SD 19%, P=0.22
Time in range (3.9-10.0 mmol/L)
74%
Rapid insulin-alone, SD 18%
Source sentences
Summary
Compared with the rapid insulin-alone artificial pancreas system, the rapid insulin-and-pramlintide system increased the time in range from 74% (SD 18%) to 84% (13%) (P = 0.0014), whereas the regular insulin-and-pramlintide system did not change the time in range (69% [19%]; P = 0.22).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-3197409902
06HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes, regular insulin-and-pramlintide had 18 hypoglycemic events versus 11 with rapid insulin alone.
In plain wordsIn adults with type 1 diabetes, regular insulin-and-pramlintide had 18 hypoglycemic events versus 11 with rapid insulin alone.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseHypoglycemic events with regular insulin
Study
n: not reported in source
Comparator
Rapid insulin-alone artificial pancreas
Outcome group
Adverse events · Metabolic and weight
Measurements
Hypoglycemic events
18 events
Regular insulin-and-pramlintide, 1 per 1.4 days
Hypoglycemic events
11 events
Rapid insulin-alone, 1 per 2.5 days
Source sentences
Summary
There were 11 (1 per 2.5 days) hypoglycemic events (<3.3 mmol/L with symptoms or <3.0 mmol/L irrespective of symptoms) with the rapid insulin-alone system, compared with 12 (1 per 2.3 days) and 18 (1 per 1.4 days) with the rapid and regular insulin-and-pramlintide systems, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-3197409905
07HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes, gastrointestinal symptoms followed 11% of meals with regular insulin-and-pramlintide versus 0% with rapid insulin alone.
In plain wordsGastrointestinal symptoms followed 11% of meals with regular insulin-and-pramlintide versus 0% with rapid insulin alone in adults with type 1 diabetes.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseGastrointestinal symptoms with regular insulin
Study
n: not reported in source
Comparator
Rapid insulin-alone artificial pancreas
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Meals followed by gastrointestinal symptoms
11%
Regular insulin-and-pramlintide, 11 of 104 meals
Meals followed by gastrointestinal symptoms
0%
Rapid insulin-alone, 0 of 112 meals
Source sentences
Summary
Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-3197409907
08HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes, neither insulin-and-pramlintide system produced severe gastrointestinal symptoms.
In plain wordsIn adults with type 1 diabetes, neither insulin-and-pramlintide system produced severe gastrointestinal symptoms.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableSevere gastrointestinal symptoms
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
Gastrointestinal symptoms were reported after 0% (0 of 112) of meals with the rapid insulin-alone system, compared with 6% (6 of 108) and 11% (11 of 104) with the rapid and regular insulin-and-pramlintide systems, respectively; none of the symptoms were severe.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a randomized crossover trial comparing a rapid insulin-alone artificial pancreas with rapid insulin-and-pramlintide and with regular insulin-and-pramlintide artificial pancreas systems in adults with type 1 diabetes.
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Report a problemFND-3197409908

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT02814123

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

McGill Universityn = 2813 Jan 2017 to 8 Jul 2018

Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 17 Feb 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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