Adjuvant liraglutide and insulin versus insulin monotherapy in the closed-loop system in type 1 diabetes: A randomized open-labeled crossover design trial

Jeniece Trast Ilkowitz, Ranjitha Katikaneni, Martin Cantwell, Neesha Ramchandani, Rubina A. Heptulla

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Background: The closed-loop (CL) system delivers insulin in a glucose-responsive manner and optimal postprandial glycemic control is difficult to achieve with the algorithm and insulin available. We hypothesized that adjunctive therapy with liraglutide, a once-daily glucagon-like peptide-1 agonist, would be more effective in normalizing postprandial hyperglycemia versus insulin monotherapy in the CL system, in patients with type 1 diabetes. Methods: This was a randomized, controlled, open-label, crossover design trial comparing insulin monotherapy versus adjuvant subcutaneous liraglutide 1.2 mg and insulin, using the CL system in 15 patients. Blood glucose (BG), insulin, and glucagon concentrations were analyzed. Results: The liraglutide arm was associated with overall decreased mean BG levels (P = .0002). The average BG levels from 8:00 pm (day 1) to 9:00 pm (day 2) were lower in the liraglutide arm (144.6 ± 36.31 vs 159.7 ± 50.88 mg/dl respectively; P = .0002). Two-hour postbreakfast and lunch BG profiles were better in the liraglutide arm (P < .05) and the insulin and glucagon assay values were lower (P < .0001). Postprandially, the area under the curve (AUC) for 2-hour postbreakfast and lunch BG levels were significant (P = .01, P = .03) and the AUC for glucagon, postbreakfast (P < .0001) and lunch (P < .05), was also significant. The incidence of hypoglycemia did not differ between arms (P = .83, Fisher's exact test). Overall, adjunct liraglutide therapy plus CL was well tolerated even with expected side effects. Conclusion: This is a proof-of-concept study showing liraglutide can be a potential adjunctive therapy in addition to CL with insulin to reduce postprandial hyperglycemia in type 1 diabetes.

Original languageEnglish (US)
Pages (from-to)1108-1114
Number of pages7
JournalJournal of diabetes science and technology
Volume10
Issue number5
DOIs
StatePublished - 2016

Fingerprint

Insulin
Medical problems
Type 1 Diabetes Mellitus
Closed loop systems
Cross-Over Studies
Glucose
Blood Glucose
Blood
Lunch
Glucagon
Hyperglycemia
Area Under Curve
Glucagon-Like Peptide 1
Liraglutide
Hypoglycemia
Peptides
Labels
Assays
Therapeutics
Incidence

Keywords

  • Closed loop
  • Glucagon like peptide-1
  • Liraglutide
  • Type 1 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Bioengineering
  • Medicine(all)
  • Biomedical Engineering

Cite this

Adjuvant liraglutide and insulin versus insulin monotherapy in the closed-loop system in type 1 diabetes : A randomized open-labeled crossover design trial. / Ilkowitz, Jeniece Trast; Katikaneni, Ranjitha; Cantwell, Martin; Ramchandani, Neesha; Heptulla, Rubina A.

In: Journal of diabetes science and technology, Vol. 10, No. 5, 2016, p. 1108-1114.

Research output: Contribution to journalArticle

Ilkowitz, Jeniece Trast ; Katikaneni, Ranjitha ; Cantwell, Martin ; Ramchandani, Neesha ; Heptulla, Rubina A. / Adjuvant liraglutide and insulin versus insulin monotherapy in the closed-loop system in type 1 diabetes : A randomized open-labeled crossover design trial. In: Journal of diabetes science and technology. 2016 ; Vol. 10, No. 5. pp. 1108-1114.
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T1 - Adjuvant liraglutide and insulin versus insulin monotherapy in the closed-loop system in type 1 diabetes

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AU - Katikaneni, Ranjitha

AU - Cantwell, Martin

AU - Ramchandani, Neesha

AU - Heptulla, Rubina A.

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AB - Background: The closed-loop (CL) system delivers insulin in a glucose-responsive manner and optimal postprandial glycemic control is difficult to achieve with the algorithm and insulin available. We hypothesized that adjunctive therapy with liraglutide, a once-daily glucagon-like peptide-1 agonist, would be more effective in normalizing postprandial hyperglycemia versus insulin monotherapy in the CL system, in patients with type 1 diabetes. Methods: This was a randomized, controlled, open-label, crossover design trial comparing insulin monotherapy versus adjuvant subcutaneous liraglutide 1.2 mg and insulin, using the CL system in 15 patients. Blood glucose (BG), insulin, and glucagon concentrations were analyzed. Results: The liraglutide arm was associated with overall decreased mean BG levels (P = .0002). The average BG levels from 8:00 pm (day 1) to 9:00 pm (day 2) were lower in the liraglutide arm (144.6 ± 36.31 vs 159.7 ± 50.88 mg/dl respectively; P = .0002). Two-hour postbreakfast and lunch BG profiles were better in the liraglutide arm (P < .05) and the insulin and glucagon assay values were lower (P < .0001). Postprandially, the area under the curve (AUC) for 2-hour postbreakfast and lunch BG levels were significant (P = .01, P = .03) and the AUC for glucagon, postbreakfast (P < .0001) and lunch (P < .05), was also significant. The incidence of hypoglycemia did not differ between arms (P = .83, Fisher's exact test). Overall, adjunct liraglutide therapy plus CL was well tolerated even with expected side effects. Conclusion: This is a proof-of-concept study showing liraglutide can be a potential adjunctive therapy in addition to CL with insulin to reduce postprandial hyperglycemia in type 1 diabetes.

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KW - Glucagon like peptide-1

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KW - Type 1 diabetes

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