March 10, 2014Diabetology & Metabolic SyndromeOpen Access

Rationale, design, and baseline characteristics of a clinical trial for prevention of atherosclerosis in patients with insulin-treated type 2 diabetes mellitus using DPP-4 inhibitor: the Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE)

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Why the study?

Does sitagliptin added to insulin therapy reduce the progression of carotid intima-media thickness in patients with type 2 diabetes mellitus?

Structured PICO

Does sitagliptin added to insulin therapy reduce the progression of carotid intima-media thickness in patients with type 2 diabetes mellitus?

Population

274 Japanese patients with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control despite insulin therapy, aged 30-79 years, free of history of cardiovascular disease. Mean age 63.7 years, 60.2% male.

Intervention

Sitagliptin 25-100 mg oral once daily added to ongoing insulin therapy.

Comparator

Conventional treatment (increasing insulin dose or adding sulfonylurea, glinide, or alpha glucosidase inhibitors) without DPP-4 inhibitors or GLP-1 analogues.

Outcome

Changes in maximum intima-media thickness (IMT) of the right and left common carotid arteries (max-IMT-CCA) and mean IMT of the right and left CCA (mean-IMT-CCA) during the 24-month treatment period.surrogate

The SPIKE trial is designed to evaluate whether adding sitagliptin to insulin therapy prevents the progression of carotid atherosclerosis in patients with type 2 diabetes.

Discussion

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Implication

Tests sitagliptin on carotid IMT progression in insulin-treated T2DM; leaves open whether it slows atherosclerosis.

Cite This Study

Mita et al. (2014) studied this question.

synapsesocial.com/papers/6a84b01c63149f2fb08e3c6b https://doi.org/10.1186/1758-5996-6-35

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Rationale, design, and baseline characteristics of a clinical trial for prevention of atherosclerosis in patients with insulin-treated type 2 diabetes mellitus using DPP-4 inhibitor: the Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE)

Structured PICO

Discussion

Implication

Cite This Study

Rationale, design, and baseline characteristics of a clinical trial for prevention of atherosclerosis in patients with insulin-treated type 2 diabetes mellitus using DPP-4 inhibitor: the Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE)

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

Also Consider