Volume 24, Issue 6 p. 1021-1028
ORIGINAL ARTICLE

Pramlintide for post-bariatric hypoglycaemia

Amanda Sheehan NP

Amanda Sheehan NP

Research Division, Joslin Diabetes Center, Boston, Massachusetts, USA

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Allison Goldfine MD

Allison Goldfine MD

Research Division, Joslin Diabetes Center, Boston, Massachusetts, USA

Harvard Medical School, Boston, Massachusetts, USA

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Muhammed Bajwa MD

Muhammed Bajwa MD

Research Division, Joslin Diabetes Center, Boston, Massachusetts, USA

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Danielle Wolfs MPH

Danielle Wolfs MPH

Research Division, Joslin Diabetes Center, Boston, Massachusetts, USA

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Chisayo Kozuka PhD

Chisayo Kozuka PhD

Research Division, Joslin Diabetes Center, Boston, Massachusetts, USA

Harvard Medical School, Boston, Massachusetts, USA

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Jacqueline Piper BSN

Jacqueline Piper BSN

Research Division, Joslin Diabetes Center, Boston, Massachusetts, USA

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Kristen Fowler NP

Kristen Fowler NP

Research Division, Joslin Diabetes Center, Boston, Massachusetts, USA

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Mary Elizabeth Patti MD

Corresponding Author

Mary Elizabeth Patti MD

Research Division, Joslin Diabetes Center, Boston, Massachusetts, USA

Harvard Medical School, Boston, Massachusetts, USA

Correspondence

Mary-Elizabeth Patti, Adult Endocrinologist and Investigator, Joslin Diabetes Center, 1 Joslin Place, Boston, MA 02215, USA.

Email: [email protected]

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First published: 08 February 2022
Citations: 2

Amanda Sheehan and Allison Goldfine contributed equally to the work.

Funding information: Bristol-Myers Squibb; NIH Clinical Center, Grant/Award Number: NIH P30 DK036836

Abstract

Aims

The aim of this study was to examine the hypothesis that pramlintide would reduce hypoglycaemia by slowing gastric emptying and reducing postprandial glucagon secretion, thus limiting postprandial glycaemic excursions and insulin secretion, and thus to determine the efficacy of pramlintide on frequency and severity of hypoglycaemia in post-bariatric hypoglycaemia (PBH).

Materials and Methods

Participants with PBH following gastric bypass were recruited from outpatient clinics at the Joslin Diabetes Center, Boston, Massachusetts for an open-label study of pramlintide efficacy over 8 weeks. Twenty-three participants were assessed for eligibility, 20 participants had at least one pramlintide dose, and 14 completed the study. A mixed-meal tolerance test (MMTT) was performed at baseline and after 8 weeks of subcutaneous pramlintide with a sequential dose increase to a maximum of 120 micrograms (mean 69 ± 32 mcg) three times daily. The primary endpoint was change in glucose excursions during the MMTT. Secondary measures included MMTT insulin response, satiety and dumping score, percentage time with sensor glucose (SG) <3.9 mM, and number of days with minimum SG <3 mM, during masked continuous glucose monitoring.

Results

There were no differences in MMTT glucose, glucagon or insulin between baseline and post treatment. We observed no significant change in satiety or dumping scores. The overall frequency of low SG values did not change, although there was substantial inter-individual variability.

Conclusions

In PBH, pramlintide does not modulate glycaemic or insulin responses, satiety, or dumping scores during an MMTT and does not impact glycaemic excursions or decrease low SG levels in the outpatient setting.

CONFLICT OF INTEREST

MEP has received clinical trial product support from Dexcom, has consulted for Eiger, Poxel, Hanmi, Astra Zeneca, MBX Biosciences, and Fractyl and has an investigator-initiated research grant for current studies from Dexcom. She was previously was a coinvestigator on an NIH R44 grant together with Xeris Pharmaceuticals. These are unrelated to the present manuscript. ABG is now employed at Novartis Institutes of Biomedical Research. All other authors declare no competing interests.

PEER REVIEW

The peer review history for this article is available at https://publons.com/publon/10.1111/dom.14665.

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available from the corresponding author upon reasonable request.