CoChat
Sign Up
Cited by 305Diabetes Treatment and ManagementDiabetes Management and ResearchDiabetes, Cardiovascular Risks, and Lipoproteins

The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

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

Open access
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
Open this paper in CoChat — free accountOpen PDF

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.

Overview

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1111/j.1463-1326.2009.01173.x

Cites

33 of 33 references verified0 citation errors · 0 not checkable

Statistics

Verification

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Citations

Cites

Show all 33 references

Research works printed but not linked: 2

  1. 10.1002/(SICI)1099-0895(199809)14:1 <S45::AID-DMR230>3.0.CO;2-7 · DOI
  2. 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

Cited by

Sorted by citations

Items 201–300 of 304

Related

See all

Metadata

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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review