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Cited by 101Diabetes Management and ResearchDiabetes Treatment and ManagementDiabetes and associated disorders

Addition of liraglutide to insulin in patients with type 1 diabetes: a randomized placebo-controlled clinical trial of 12 weeks

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Kuhadiya, Nitesh D., Dhindsa, Sandeep, Ghanim, Husam, Mehta, Aditya, Makdissi, Antoine, Batra, Manav, Sandhu, Sartaj, Hejna, Jeanne +5 more·2016·Diabetes Care
DOI 10.2337/dc15-1136PMC PMC5864130
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Abstract

OBJECTIVE: To investigate whether addition of three different doses of liraglutide to insulin in patients with type 1 diabetes (T1D) results in significant reduction in glycemia, body weight, and insulin dose. RESEARCH DESIGN AND METHODS: We randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks. RESULTS: In the 1.2-mg and 1.8-mg groups, the mean weekly reduction in average blood glucose was −0.55 ± 0.11 mmol/L (10 ± 2 mg/dL) and −0.55 ± 0.05 mmol/L (10 ± 1 mg/dL), respectively (P < 0.0001), while it remained unchanged in the 0.6-mg and placebo groups. In the 1.2-mg group, HbA1c fell significantly (−0.78 ± 15%, −8.5 ± 1.6 mmol/mol, P < 0.01), while it did not in the 1.8-mg group (−0.42 ± 0.15%, −4.6 ± 1.6 mmol/mol, P = 0.39) and 0.6-mg group (−0.26 ± 0.17%, −2.8 ± 1.9 mmol/mol, P = 0.81) vs. the placebo group (−0.3 ± 0.15%, −3.3 ± 1.6 mmol/mol). Glycemic variability was reduced by 5 ± 1% (P < 0.01) in the 1.2-mg group only. Total daily insulin dose fell significantly only in the 1.2-mg and 1.8-mg groups (P < 0.05). There was a 5 ± 1 kg weight loss in the two higher-dose groups (P < 0.05) and by 2.7 ± 0.6 kg (P < 0.01) in the 0.6-mg group vs. none in the placebo group. In the 1.2- and 1.8-mg groups, postprandial plasma glucagon concentration fell by 72 ± 12% and 47 ± 12%, respectively (P < 0.05). Liraglutide led to higher gastrointestinal adverse events (P < 0.05) and ≤1% increases (not significant) in percent time spent in hypoglycemia (<55 mg/dL, 3.05 mmol/L). CONCLUSIONS: Addition of 1.2 mg and 1.8 mg liraglutide to insulin over a 12-week period in overweight and obese patients with T1D results in modest reductions of weekly mean glucose levels with significant weight loss, small insulin dose reductions, and frequent gastrointestinal side effects. These findings do not justify the use of liraglutide in all patients with T1D.

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Authors
Kuhadiya, N. D., Dhindsa, S., Ghanim, H., Mehta, A., Makdissi, A., Batra, M., Sandhu, S., Hejna, J., Green, K., Bellini, N., Yang, M., Chaudhuri, A., & Dandona, P.
Affiliations
University at Buffalo, State University of New York (US)
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2016-04-05
Volume
39
Issue
6
Pages
1027-1035
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc15-1136
PMC
PMC5864130
OpenAlex
W2337735601
Cited by
101
References
15
Citations by year
2026: 9 · 2025: 12 · 2024: 9 · 2023: 9 · 2022: 9 · 2021: 7 · 2020: 10 · 2019: 9 · 2018: 12 · 2017: 6 · 2016: 8
FWCI
11.72
Type
journal article
Language
en
Open access
Licence
www.diabetesjournals.org/site/license (vor, 240 d)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Novo Nordisk
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
liraglutide, type 1 diabetes, insulin therapy, glycemic control, HbA1c, glycemic variability, insulin dose reduction, weight loss, GLP-1 receptor agonists, dose-response relationship, blood glucose variability, insulin pump therapy, insulin-to-carbohydrate ratio, insulin resistance
MeSH terms
Liraglutide, Adult, Blood Glucose, Body Weight, Diabetes Mellitus, Type 1, Double-Blind Method, Drug Therapy, Combination, Female, Glucagon, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Obesity, Time Factors, Treatment Outcome, Postprandial Period, Overweight

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