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Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes

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Vilsbøll, T., Rosenstock, J., Yki‐Järvinen, H., Cefalu, W. T., Chen, Y., Luo, E., Musser, B., Andryuk, P. J. +5 more·2010·Diabetes, Obesity and Metabolism
DOI 10.1111/j.1463-1326.2009.01173.x
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Abstract

Objective: To evaluate the efficacy and tolerability of sitagliptin when added to insulin therapy alone or in combination with metformin in patients with type 2 diabetes. Methods: After a 2 week placebo run‐in period, eligible patients inadequately controlled on long‐acting, intermediate‐acting or premixed insulin (HbA1c ≥ 7.5% and ≤ 11%), were randomised 1:1 to the addition of once‐daily sitagliptin 100 mg or matching placebo over a 24‐week study period. The study capped the proportion of randomised patients on insulin plus metformin at 75%. Further, the study capped the proportion of randomised patients on premixed insulin at 25%. The metformin dose and the insulin dose were to remain stable throughout the study. The primary endpoint was HbA1c change from baseline at week 24. Results: Mean baseline characteristics were similar between the sitagliptin (n = 322) and placebo (n = 319) groups, including HbA1c (8.7 vs. 8.6%), diabetes duration (13 vs. 12 years), body mass index (31.4 vs. 31.4 kg/m 2 ), and total daily insulin dose (51 vs. 52 IU), respectively. At 24 weeks, the addition of sitagliptin significantly (p < 0.001) reduced HbA1c by 0.6% compared with placebo (0.0%). A greater proportion of patients achieved an HbA1c level < 7% while randomised to sitagliptin as compared with placebo (13 vs. 5% respectively; p < 0.001). Similar HbA1c reductions were observed in the patient strata defined by insulin type (long‐acting and intermediate‐acting insulins or premixed insulins) and by baseline metformin treatment. The addition of sitagliptin significantly (p < 0.001) reduced fasting plasma glucose by 15.0 mg/dl (0.8 mmol/l) and 2‐h postmeal glucose by 36.1 mg/dl (2.0 mmol/l) relative to placebo. A higher incidence of adverse experiences was reported with sitagliptin (52%) compared with placebo (43%), due mainly to the increased incidence of hypoglycaemia (sitagliptin, 16% vs. placebo, 8%). The number of hypoglycaemic events meeting the protocol‐specified criteria for severity was low with sitagliptin (n = 2) and placebo (n = 1). No significant change from baseline in body weight was observed in either group. Conclusion: In this 24‐week study, the addition of sitagliptin to ongoing, stable‐dose insulin therapy with or without concomitant metformin improved glycaemic control and was generally well tolerated in patients with type 2 diabetes.

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  • Pharmacokinetic and pharmacodynamic studies show an additive effect on blood glucose decreases when combining GLP-1 receptor agonists and basal insulin analogs.

    “Pharmacokinetic and pharmacodynamic studies of combination GLP-1 RAs and basal insulin analogs have shown an additive effect on BG decreases.1021,1094–1097”

    From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [1095]

    The Efficacy section (page unavailable) reports that adding sitagliptin to insulin reduced plasma glucose, supporting the general point that an add-on treatment improved glucose control. But sitagliptin is a DPP-4 inhibitor, not a GLP-1 receptor agonist, and the paper does not establish an additive effect specifically for GLP-1 receptor agonists combined with basal insulin analogs in pharmacokinetic and pharmacodynamic studies. (LLM, conf=0.85)

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Authors
Vilsbøll, T., Rosenstock, J., Yki‐Järvinen, H., Cefalu, W. T., Chen, Y., Luo, E., Musser, B., Andryuk, P. J., Ling, Y., Kaufman, K. D., Amatruda, J. M., Engel, S. S., & Katz, L.
Affiliations
  • University of Copenhagen (DK)
  • Medical City Dallas Hospital (US)
  • Pennington Biomedical Research Center (US)
  • Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
Corresponding author
Katz, L.
ORCID
Venue
Diabetes, Obesity and Metabolism
Publisher
Wiley
Published
2009-12-29
Volume
12
Issue
2
Pages
167-177
ISSN
  • 1462-8902 (ISSN-L)
  • 1463-1326
DOI
10.1111/j.1463-1326.2009.01173.x
OpenAlex
W2038953694
Cited by
305
References
33
Citations by year
2026: 1 · 2025: 1 · 2024: 2 · 2023: 4 · 2022: 4 · 2021: 6 · 2020: 11 · 2019: 12 · 2018: 22 · 2017: 13 · 2016: 32 · 2015: 38 · 2014: 32 · 2013: 53 · 2012: 33
FWCI
17.97
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Diabetes Obesity and Metabolism (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
sitagliptin, type 2 diabetes, insulin therapy, DPP-4 inhibitors, metformin, glycemic control, HbA1c, fasting blood glucose, postprandial blood glucose, adverse events, hypoglycemia, drug safety, combination therapy, long-acting insulin, premixed insulin, intermediate-acting insulin, tolerability, dipeptidyl peptidase IV
MeSH terms
Sitagliptin Phosphate, Diabetes Mellitus, Type 2, Double-Blind Method, Drug Therapy, Combination, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Metformin, Middle Aged, Pyrazines, Triazoles, Body Mass Index, Treatment Outcome

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