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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., Ling, Y., Kaufman, K. D., Amatruda, J. M., Engel, S. S., Katz, L.·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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10.1002/(SICI)1099-0895(199809)14:1 <S45::AID-DMR230>3.0.CO;2-7 · DOI
Rosenstock J, 2008, Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without increasing weight gain or hypoglycemia, Diabetes, 57, A132

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Self-citation
Cardiovascular Safety of Dipeptidyl-Peptidase IV Inhibitors: A Meta-Analysis of Placebo-Controlled Randomized Trials
Elgendy, I. Y., Mahmoud, A. N., Barakat, A. F., Elgendy, A. Y., Saad, M. S., Abu‐Zaid, A., Wayangankar, S. A., & Bavry, A. A. (2016) · American Journal of Cardiovascular Drugs · doi:10.1007/s40256-016-0208-x · Cited by 41
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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: Vilsbøll, T.
Rosenstock, J.
Cefalu, W. T.
Musser, B.
Kaufman, K. D.
Engel, S. S.
Katz, L.
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: bronze
doi.org
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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Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes

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