Safety and Tolerability of Sitagliptin in Type 2 Diabetes Patients
Author Information
Author(s): Williams-Herman Debora, Round Elizabeth, Swern Arlene S, Musser Bret, Davies Michael J, Stein Peter P, Kaufman Keith D, Amatruda John M
Primary Institution: Merck Research Laboratories, Rahway, NJ, USA
Hypothesis
The analysis aims to assess the safety and tolerability of sitagliptin in patients with type 2 diabetes.
Conclusion
Sitagliptin 100 mg/day was well tolerated in clinical trials lasting up to 2 years.
Supporting Evidence
- The incidence rates of adverse experiences were similar between the sitagliptin and non-exposed groups.
- Sitagliptin showed a lower incidence of hypoglycemia compared to the non-exposed group.
- No meaningful differences in laboratory adverse experiences were observed between treatment groups.
Takeaway
This study looked at how safe and well people with diabetes tolerated a medicine called sitagliptin over two years.
Methodology
The analysis pooled data from 12 double-blind, Phase IIb and III studies involving patients treated with sitagliptin or comparator agents.
Potential Biases
Potential bias due to the involvement of authors employed by the manufacturer of sitagliptin.
Limitations
The studies were not specifically designed as cardiovascular outcome trials.
Participant Demographics
Average age of participants was 55 years, with 55% men and a diverse racial/ethnic breakdown.
Digital Object Identifier (DOI)
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