Rationale, Design, and Baseline Characteristics of a Trial for the Prevention of Diabetic Atherosclerosis Using a DPP-4 Inhibitor: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A)

Katakami, Naoto; Mita, Tomoya; Yoshii, Hidenori; Onuma, Tomio; Kaneto, Hideaki; Osonoi, Takeshi; Shiraiwa, Toshihiko; Kosugi, Ken’ichirou; Umayahara, Yutaka; Yamamoto, Tohru; Yokoyama, Hiroyuki; Kuribayashi, Nobuichi; Jinnouchi, Hideaki; Gosho, Masahiko; Watada, Hirotaka; Shimomura, Iichiro

doi:10.5551/jat.18333

Cited by 14 publications

(10 citation statements)

References 30 publications

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“…The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A) trial was a multicenter prospective, randomized, open-label, blinded-end point (PROBE) study, as described previously (20). This study was registered on the University Hospital Medical Information Network Clinical Trials Registry (UMIN000005311), a nonprofit organization in Japan that meets the requirements of the International Committee of Medical Journal Editors (ICMJE).…”

Section: Methodsmentioning

confidence: 99%

Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A)

et al. 2015

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OBJECTIVERecent experimental studies have shown that dipeptidyl peptidase 4 (DPP-4) inhibitors have antiatherosclerotic benefits in glucagon-like peptide 1-dependent and -independent manners. The current study investigated the effects of alogliptin, a DPP-4 inhibitor, on the progression of carotid atherosclerosis in patients with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODSThis prospective, randomized, open-label, blinded-end point, multicenter, parallelgroup, comparative study included 341 patients with T2DM free of a history of apparent cardiovascular diseases recruited at 11 clinical units and randomly allocated to treatment with alogliptin (n = 172) or conventional treatment (n = 169). Primary outcomes were changes in mean common and maximum intima-media thickness (IMT) of the carotid artery measured by carotid arterial echography during a 24-month treatment period. RESULTSAlogliptin treatment had a more potent glucose-lowering effect than the conventional treatment (20.3 6 0.7% vs. 20.1 6 0.8%, P = 0.004) without an increase of hypoglycemia. Changes in the mean common and the right and left maximum IMT of the carotid arteries were significantly greater after alogliptin treatment than after conventional treatment (20.026 mm [SE 0.009] CONCLUSIONSAlogliptin treatment attenuated the progression of carotid IMT in patients with T2DM free of apparent cardiovascular disease compared with the conventional treatment.

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Section: Methodsmentioning

confidence: 99%

Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A)

et al. 2015

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“…Alogliptin is prescribed to be combined with metformin even though they have different mechanisms of action in improving glucose metabolism [ 17 ]. Moreover, alogliptin can reduce inflammation and thereby perform anti-atherosclerotic effects by inhibiting the monocyte activation/chemotaxis [ 19 ]; it prevents migration of monocytes and actin polymerization via Rac-dependent mechanism [ 20 ], and can act by inhibiting the inflammation in diabetic apoE-deficient in animals [ 21 ].…”

Section: Resultsmentioning

confidence: 99%

“…Alogliptin, a DDP-4 inhibitor has advantage over other antidiabetic agents as it does not produce weight gain [ 66 ], and its ability to inhibit atherosclerosis and inflammation [ 19 ]. Alogliptin helps to improve glycemic control in adults with T2DM together with diet and exercise plan [ 18 ].…”

Section: Resultsmentioning

confidence: 99%

Systematic Review of Efficacy and Safety of Newer Antidiabetic Drugs Approved from 2013 to 2017 in Controlling HbA1c in Diabetes Patients

et al. 2018

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Type 2 Diabetes Mellitus (T2DM) is the most common form of diabetes mellitus and accounts for about 95% of all diabetes cases. Many newer oral as well as parenteral antidiabetic drugs have been introduced in to the market in recent years to control hyperglycemic conditions in diabetes patients and many of these drugs produce potential side effects in diabetes patients. Hence, this systematic review was aimed to analyze and compare the efficacy and safety of oral antidiabetic agents in controlling HbA1c in T2DM patients, that were approved by the United States-Food and Drug Administration (US-FDA) from 2013 to 2017. All randomized controlled, double-blind trials published in English during the search period involving the newer antidiabetic agents were selected. In the outcome assessment comparison, semaglutide demonstrated the highest efficacy in lowering HbA1c, with a 1.6% reduction (p < 0.0001) when given at a dose of 1.0 mg. The safety profile of all the agents as compared to placebo or control were similar, with no or slight increase in the occurrence of adverse events (AEs) but no fatal reaction was reported. The most common AEs of all the antidiabetic agents were gastrointestinal in nature, with several cases of hypoglycemic events. However, among all these agents, semaglutide seems to be the most efficacious drug to improve glycemic control in terms of HbA1c. Alogliptin has the least overall frequency of AEs compared to other treatment groups.

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“…Ultrasonographic scans of the carotid artery are performed by expert sonographers who are specifically trained to perform the prescribed study examination, as reported previously [36]. To avoid inter-sonographer variability, each participant is examined by the same sonographer with the same equipment (high-resolution B-mode ultrasound scanner equipped with a high frequency (>7.5-MHz) linear transducer, with a limit of detection of <0.1 mm) throughout all the visits.…”

Section: Methods and Designmentioning

confidence: 99%

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)

Mita

Katakami

Shiraiwa³

et al. 2014

Diabetol Metab Syndr

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BackgroundSitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is currently used to achieve glycemic targets in patients with type 2 diabetes mellitus (T2DM). The addition of DPP-4 inhibitors to ongoing insulin therapy is expected to reduce insulin dosage, leading to a reduction in the frequency of hypoglycaemia and/or weight gain. Recent studies have demonstrated potential anti-atherosclerotic effects for DPP-4 inhibitors. The aim of the present ongoing study is to assess the effects of sitagliptin on the progression of atherosclerosis in patients with insulin-treated T2DM using carotid intima-media thickness (IMT), an established marker of cardiovascular disease.Methods and DesignThe Sitagliptin Preventive study of Intima media thickness Evaluation (SPIKE) is a prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study. Between February 2012 and September 2012, 282 participants who failed to achieve glycemic control despite insulin therapy were recruited at 12 clinics and randomly allocated to the sitagliptin group (n = 142) or the control group (n = 140). Primary outcomes are changes in maximum and mean IMT of the common carotid artery after 24-month treatment period measured by carotid arterial echography. Secondary outcomes include changes in glycemic control, parameters related to beta-cell function and diabetic nephropathy, occurrence of cardiovascular events and adverse events such as hypoglycaemia, and biochemical markers of vascular function.DiscussionThe present study is designed to assess the effects of sitagliptin on the progression of carotid IMT. Results will be available in the near future, and the findings are expected to provide new strategy to prevent atherosclerosis in patients with insulin-treated T2DM.Clinical Trial RegistrationUMIN000007396

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Rationale, Design, and Baseline Characteristics of a Trial for the Prevention of Diabetic Atherosclerosis Using a DPP-4 Inhibitor: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A)

Cited by 14 publications

References 30 publications

Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A)

Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A)

Systematic Review of Efficacy and Safety of Newer Antidiabetic Drugs Approved from 2013 to 2017 in Controlling HbA1c in Diabetes Patients

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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