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.

Andersen G, Eloy R, Famulla S, Heise T, Meiffren G, Seroussi C, Gaudier M, Mégret C, Chan YP, Soula O, Riddle M

Diabetes, obesity & metabolism31 Jan 2023Cited by 7 (Europe PMC)

PMID36633505DOI10.1111/dom.14972PepBankPUB-36633505

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 study11

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone11

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).

01HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with T1D, ADO09 lowered post-meal glucose increments by 39% versus aspart in the low-dose group, without statistical significance.
In plain wordsIn adults with T1D, ADO09 produced a statistically nonsignificant reduction in post-meal glucose versus aspart in the low-dose group.
Peptide
Pramlintide (Symlin)
Outcome
No significant changePost-meal glucose increment, low-dose group
Study
n = 28
Comparator
insulin aspart
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Glucose increment reduction
39%
low-dose group versus aspart
Source sentences
Summary
Glucose increments from 0 to 4 h after mixed-meal-tolerance test (primary endpoint) were 39% (not statistically significantly) lower with ADO09 in the low-dose group and 69% lower in the high-dose group.
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350501
02HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with T1D, ADO09 lowered post-meal glucose increments by 69% versus aspart in the high-dose group.
In plain wordsIn adults with T1D, ADO09 reduced post-meal glucose more than aspart in the high-dose group.
Peptide
Pramlintide (Symlin)
Outcome
DecreasePost-meal glucose increment, high-dose group
Study
n = 16
Comparator
insulin aspart
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Glucose increment reduction
69%
high-dose group versus aspart
Source sentences
Summary
Glucose increments from 0 to 4 h after mixed-meal-tolerance test (primary endpoint) were 39% (not statistically significantly) lower with ADO09 in the low-dose group and 69% lower in the high-dose group.
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350502
03HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with T1D, ADO09 lowered mean monitored glucose versus aspart in the low-dose group.
In plain wordsIn adults with T1D, ADO09 lowered average glucose more than aspart in the low-dose group.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseMean glucose, low-dose group
Study
n = 28
Comparator
insulin aspart
Outcome group
Glycemic control · Metabolic and weight
Measurements
Mean glucose difference
−8.2 mg/dl
low-dose ADO09 versus aspart
p value
0.0001
low-dose mean glucose
Source sentences
Summary
Mean continuous glucose monitoring glucose during ambulatory treatment was lower with ADO09 than with aspart (LD: -8.2 ± 7.9 mg/dl, p = .0001; HD: -7.0 ± 10 mg/ml, p = .0127)
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350503
04HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with T1D, ADO09 improved time in range versus aspart in the low-dose group.
In plain wordsIn adults with T1D, ADO09 increased time within the glucose target range versus aspart in the low-dose group.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseTime in range, low-dose group
Study
n = 28
Comparator
insulin aspart
Outcome group
Glycemic control · Metabolic and weight
Measurements
Time-in-range improvement
4%
low-dose ADO09 versus aspart
p value
0.0134
low-dose time in range
Source sentences
Summary
Mean continuous glucose monitoring glucose during ambulatory treatment was lower with ADO09 than with aspart (LD: -8.2 ± 7.9 mg/dl, p = .0001; HD: -7.0 ± 10 mg/ml, p = .0127), and time-in-range (70-180 mg/dl) improved (LD: +4%, p = .0134; HD: +4%, p = .0432).
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350505
05HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with T1D, body weight declined significantly with ADO09 in the low-dose group.
In plain wordsIn adults with T1D, body weight decreased during ADO09 treatment in the low-dose group.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight, low-dose group
Study
n = 28
Outcome group
Body weight · Metabolic and weight
Measurements
Body weight change
−0.8 kg
low-dose ADO09
Source sentences
Summary
Body weight declined significantly with ADO09 (LD: -0.8 kg; HD: -1.6 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350507
06HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with T1D, hypoglycemic events were slightly more frequent with ADO09 than aspart in the low-dose group.
In plain wordsIn adults with T1D, ADO09 caused slightly more low-glucose events than aspart in the low-dose group.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseHypoglycemic events, low-dose group
Study
n = 28
Comparator
insulin aspart
Outcome group
Adverse events · Metabolic and weight
Measurements
Hypoglycemic events
142 events
low-dose ADO09
Hypoglycemic events
115 events
low-dose aspart
Source sentences
Summary
Hypoglycaemic events were slightly more frequent with ADO09 versus aspart (LD: 142 vs. 115; HD: 96 vs. 79).
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350509
07HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with T1D, ADO09 lowered mean monitored glucose versus aspart in the high-dose group.
In plain wordsIn adults with T1D, ADO09 lowered average glucose more than aspart in the high-dose group.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseMean glucose, high-dose group
Study
n = 16
Comparator
insulin aspart
Outcome group
Glycemic control · Metabolic and weight
Measurements
Mean glucose difference
−7 mg/ml
high-dose ADO09 versus aspart
p value
0.0127
high-dose mean glucose
Source sentences
Summary
Mean continuous glucose monitoring glucose during ambulatory treatment was lower with ADO09 than with aspart (LD: -8.2 ± 7.9 mg/dl, p = .0001; HD: -7.0 ± 10 mg/ml, p = .0127)
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350504
08HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with T1D, ADO09 improved time in range versus aspart in the high-dose group.
In plain wordsIn adults with T1D, ADO09 increased time within the glucose target range versus aspart in the high-dose group.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseTime in range, high-dose group
Study
n = 16
Comparator
insulin aspart
Outcome group
Glycemic control · Metabolic and weight
Measurements
Time-in-range improvement
4%
high-dose ADO09 versus aspart
p value
0.0432
high-dose time in range
Source sentences
Summary
Mean continuous glucose monitoring glucose during ambulatory treatment was lower with ADO09 than with aspart (LD: -8.2 ± 7.9 mg/dl, p = .0001; HD: -7.0 ± 10 mg/ml, p = .0127), and time-in-range (70-180 mg/dl) improved (LD: +4%, p = .0134; HD: +4%, p = .0432).
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350506
09HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with T1D, body weight declined significantly with ADO09 in the high-dose group.
In plain wordsIn adults with T1D, body weight decreased during ADO09 treatment in the high-dose group.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseBody weight, high-dose group
Study
n = 16
Outcome group
Body weight · Metabolic and weight
Measurements
Body weight change
−1.6 kg
high-dose ADO09
Source sentences
Summary
Body weight declined significantly with ADO09 (LD: -0.8 kg; HD: -1.6 kg).
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350508
10HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with T1D, hypoglycemic events were slightly more frequent with ADO09 than aspart in the high-dose group.
In plain wordsIn adults with T1D, ADO09 caused slightly more low-glucose events than aspart in the high-dose group.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseHypoglycemic events, high-dose group
Study
n = 16
Comparator
insulin aspart
Outcome group
Adverse events · Metabolic and weight
Measurements
Hypoglycemic events
96 events
high-dose ADO09
Hypoglycemic events
79 events
high-dose aspart
Source sentences
Summary
Hypoglycaemic events were slightly more frequent with ADO09 versus aspart (LD: 142 vs. 115; HD: 96 vs. 79).
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350510
11HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with T1D, ADO09 produced more gastrointestinal events than aspart, but these were generally transient.
In plain wordsIn adults with T1D, ADO09 caused more digestive side effects than aspart, but these generally passed.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseGastrointestinal events
Study
n: not reported in source
Comparator
insulin aspart
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
Gastrointestinal events occurred more frequently with ADO09 but were generally transient, and no other safety signals were identified.
2 context sentences(design, population, supporting numbers)
Summary · context
We investigated the pharmacokinetics/pharmacodynamics, efficacy and safety of ADO09, pramlintide/insulin A21G co-formulation, in type 1 diabetes (T1D).
Summary · context
This double-blinded, randomized, two-period cross-over study compared prandial administration of ADO09 or insulin aspart over 24 days in T1D using either ≤40 U bolus insulin per day [low-dose group (LD), n = 28] or 40-75 U [high-dose group (HD), n = 16].
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-3663350511

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 1/2NCT03981627

A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

Adocian = 446 Jun 2019 to 27 Jun 2020

Type 1 Diabetes Mellitus

Trial page ClinicalTrials.govUpdated 30 Nov 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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