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Published on: June 11, 2012
Vildagliptin versus insulin in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea:
Thomas Forst1, Cornelia Koch, Markus Dworak
1Profil Mainz GmbH & Co. KG , Mainz , Germany.
Objective:
There is limited evidence to guide the selection of second-line anti-hyperglycemic agents in patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with sulfonylurea monotherapy and are intolerant to metformin. We compared the efficacy and safety of vildagliptin 50 mg qd and Neutral Protamine Hagedorn (NPH) insulin qd in such patients.
Methods:
This was a 24 week, multicenter, randomized, open-label study. The co-primary endpoints were (i) proportion of patients achieving HbA1c <7.0% without any confirmed hypoglycemic events (HEs) or weight gain ≥3% (composite endpoint); (ii) rate of confirmed HEs. Treatment satisfaction was assessed using the TSQM-9 questionnaire at study end.
Results:
A total of 162 patients were randomly assigned to vildagliptin (n = 83) and NPH insulin (n = 79). Similar proportion of patients achieved the composite endpoint in vildagliptin versus NPH insulin group (35.4% versus 34.2%; OR 0.985; 95% CI 0.507, 1.915; p = 0.96). After 24 weeks, 48.8% of patients in the vildagliptin group and 60.8% in the NPH insulin group achieved HbA1c <7.0%; 13.4% in the vildagliptin group and 29.1% in the insulin group had at least one confirmed HE; while 11.0% in the vildagliptin group and 22.8% in the insulin group experienced weight gain. The rate of confirmed HEs was significantly lower in patients receiving vildagliptin versus NPH insulin (1.3 versus 5.1 events per year). The TSQM-9 score for 'convenience' at week 24 increased significantly more with vildagliptin than with NPH insulin.
Conclusions:
Addition of vildagliptin and NPH insulin resulted in a similar number of patients reaching HbA1c target without HEs or weight gain in T2DM patients inadequately controlled with sulfonylurea. The addition of vildagliptin to sulfonylurea could be considered as a treatment option prior to intensification with insulin, with the advantages of a lower HE rate and greater patient convenience. Study results are limited by a higher drop-out rate in the vildagliptin arm.
Insights
In type 2 diabetes, vildagliptin and NPH insulin showed similar efficacy when added to sulfonylurea. Vildagliptin offered fewer hypoglycemia events and greater convenience for patients inadequately controlled on sulfonylurea.
Area of Science:
- Endocrinology
- Pharmacology
- Metabolic Diseases
Background:
- Type 2 diabetes mellitus (T2DM) management requires effective second-line therapies when sulfonylurea monotherapy is insufficient and metformin is not tolerated.
- Limited evidence exists for selecting optimal second-line agents in this specific patient population.
Purpose of the Study:
- To compare the efficacy and safety of vildagliptin versus Neutral Protamine Hagedorn (NPH) insulin as second-line treatments in T2DM patients inadequately controlled on sulfonylurea and intolerant to metformin.
- To evaluate glycemic control, hypoglycemia events, weight changes, and treatment satisfaction.
Main Methods:
- A 24-week, multicenter, randomized, open-label study.
- Co-primary endpoints included the proportion of patients achieving HbA1c <7.0% without hypoglycemia or weight gain, and the rate of confirmed hypoglycemia events.
- Treatment satisfaction was assessed using the TSQM-9 questionnaire.
Main Results:
- 162 patients were randomized to vildagliptin (n=83) or NPH insulin (n=79).
- Similar proportions achieved the composite endpoint (35.4% vs 34.2%).
- Vildagliptin demonstrated a significantly lower rate of confirmed hypoglycemia (1.3 vs 5.1 events/year) and greater treatment convenience compared to NPH insulin. HbA1c <7.0% was achieved by 48.8% on vildagliptin vs 60.8% on insulin.
Conclusions:
- Vildagliptin and NPH insulin provide similar glycemic control when added to sulfonylurea in T2DM patients with metformin intolerance.
- Vildagliptin presents a viable option prior to insulin intensification, offering reduced hypoglycemia risk and improved patient convenience.
- Higher dropout rates in the vildagliptin arm warrant consideration.
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