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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004490
Receipt No. R000005356
Scientific Title Program of vascular evaluation under glucose control by DPP-4 inhibitor
Date of disclosure of the study information 2010/11/01
Last modified on 2017/05/12

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Basic information
Public title Program of vascular evaluation under
glucose control by DPP-4 inhibitor
Acronym PROLOGUE
Scientific Title Program of vascular evaluation under
glucose control by DPP-4 inhibitor
Scientific Title:Acronym PROLOGUE
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of a DDP-4 inhibitor in prevention of progression of atherosclerosis by comparing patients receiving a DPP-4 inhibitor to those receiving standard treatment based on carotid-artery intima-media thickness (IMT) assessed by ultrasonography. Effects on cardiovascular function and blood biomarkers are also evaluated. Sitagliptin is used as a DDP-4 inhibitor.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The % changes of the mean IMT value after 24 months from the baseline which assessed by ultrasonography.
Key secondary outcomes 1) The measured value of ultrasonography and the % changes and variation at the point of baseline, and at after 12 and 24 months.
Common carotid artery: excluding the % of changes at the point of 24 months.
Sphere, Internal carotid artery: the maximum IMT value, plaque area, plaque luminance

2) Laboratory test values indicated below at baseline, and after 12 and 24 months, and changes and %changes in the values from baseline.
NT-proBNP, high-sensitivity CRP, 1,5AG, small-dense LDL, high-molecular-weight adiponectin, RLP-C, and MDA-LDL

3) Laboratory test values indicated below at baseline, and after 3, 6, 12 and 24 months, and changes and %changes in the values from baseline.
HbA1c, fasting blood glucose, insulin, serum lipids (TC,HDL-C, and TG), serum creatinine, urinary albumin excretion (creatinine corrected value), eGFR (converted value), HOMA-beta and HOMA-R (converted values) and cystatin C

4) Cardiovascular function parameters indicated below at baseline, and after 12 and 24 months, and changes and %changes in the values from baseline.
Echocardiogram (systolic and diastolic function, left atrial dimension, and left ventricular mass index), flow-mediated dilation (FMD), pulse wave velocity (PWV), cardio-ankle vascular Index (CAVI), and atherogenic index (AI)

5) Values indicated below at baseline, and after 3, 6, 12 and 24 months, changes and %changes in the values from baseline, and incidence of significant clinical symptoms.
Blood pressure (ambulant), weight and incidence of significant weight change, and incidence of hypoglycemia symptoms

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group receiving sitagliptin (DPP-4 inhibitor treated group)
Interventions/Control_2 Group receiving standard treatment (non-DPP-4 inhibitor treated group)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with type 2 diabetes who had received diet and exercise therapy or diet, exercise and pharmacologic therapy with oral antidiabetic agents other than a DPP-4 inhibitor for more than 3 months and whose blood glucose have not been sufficiently controlled (5.8% <= HbA1c(JDS) < 9.0%)
2) Outpatients aged >= 30 years of both sexes
3) Patients who have given written informed consent to participate in the study
Key exclusion criteria 1) Patients with type 1 diabetes
2) Patients who had a history of severe ketosis, diabetic coma or precoma within 6 months
3) Patients before or after operation, and those with severe infections or serious injury
4) Patients with severe kidney dysfunction (eGFR: <30 mL/min or patients under dialysis)
5) Patients who had myocardial infarction, angina, percutaneous transluminal coronary angioplasty / bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient cerebral ischemic attack within 3 months before the study initiation.
6) Patients with moderate or severe cardiac dysfunction (NYHA class III or IV)
7) Patients who are being treated with a DPP-4 inhibitor or glucagon-like peptide-1 (GLP-1) analog at the time of the study initiation
8) Patients who are being treated with insulin at the time of the study initiation
9) Pregnant, possible pregnant, or lactating women
10) Patients with a history of hypersensitivity to the study drug
11) Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Node/Toyoaki Murohara
Organization Saga University/Nagoya University
Division name Department of Cardiovascular Medicine
Zip code
Address 5-1-1 Nabeshima, Saga-shi, Saga / 65 Tsurumai-cho ,Showa-ku, Nagoya-shi, Aichi
TEL 0952-34-2364
Email node@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Oyama
Organization Study group for diabetes mellitus and vascular lesion
Division name Secretariat
Zip code
Address 5-1-1Nabeshima, Saga-shi, Saga
TEL 0952-34-2364
Homepage URL
Email junoyama@cc.saga-u.ac.jp

Sponsor
Institute Study group for diabetes mellitus and vascular lesion secretariat
Institute
Department

Funding Source
Organization Clinical Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Hokkaido univ,Akita univ,Dokkyo Medical univ,Tskuba univ,Showa univ,Nippon Medical univ,Tokyo Wemen's Medical univ,Juntendo univ,Tokyo Medical univ,Yokohama City univ,Mie univ,Osaka univ,etc
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学(北海道)、秋田大学(秋田県)、獨協医科大学(栃木県)、筑波大学(茨城県)、昭和大学(東京都)、日本医科大学(東京都)、東京女子医大(東京都)、順天堂大学(東京都)、東京医科大学(東京都)、横浜市立大学(神奈川県)、名古屋大学(愛知県)、三重大学(三重県)、大阪大学(大阪府)、大阪市立大学(大阪府)、国立循環器病研究センター(大阪府)、徳島大学(徳島県)、川崎医科大学(岡山県)、広島大学(広島県)、広島市立広島市民病院(広島県)、島根大学(島根県)、長崎大学(長崎県)、琉球大学(沖縄県)、佐賀大学(佐賀県)、トヨタ記念病院(愛知県)、北光記念病院(北海道)、津島市民病院(愛知県)、名古屋掖済会病院(愛知県)、四日市社会保険病院(愛知県)、大村市民病院(長崎県)、松崎内科循環器科(長崎県)、小牧市民病院(愛知県)、徳島県立中央病院(徳島県)、一宮市立市民病院(愛知県)、春日井市民病院(愛知県)、名古屋第一赤十字病院(愛知県)、西尾市民病院(愛知県)、宮崎大学(宮崎県)、三菱名古屋病院(愛知県)、名古屋セントラル病院(愛知県)、名古屋第二赤十字病院(愛知県)、藤田保健衛生大学坂文種報徳會病院(愛知県)、安城更生病院(愛知県)、北松中央病院(長崎県)、土岐市立総合病院(岐阜県)、岐阜県立多治見病院(岐阜県)、佐世保市立総合病院(長崎県)、常滑市民病院(愛知県)、長崎川棚医療センター(長崎県)、光晴会病院(長崎県)、国立長寿医療研究センター病院(愛知)、江南厚生病院(愛知)、ブラザー記念病院(愛知)、 公立陶生病院
(愛知)、半田市立半田病院(愛知)、中部ろうさい病院(愛知)、中日病院(愛知)、名城病院(愛知)、国立名古屋医療センター(愛知)、名古屋共立病院(愛知)、海南病院 (愛知)、佐世保中央病院(長崎)、市立四日市病院(三重)、東京医科大学茨城医療センター(茨城)、中津川市民病院(岐阜)、宮崎市郡医師会病院(宮崎)、上田脳神経外科(宮崎)、山元記念病院(佐賀)、佐賀記念病院(佐賀)、ふじおか病院(佐賀)、内藤医院北山診療所(佐賀)、江口病院(佐賀)、ひらまつ病院(佐賀)、池田内科・皮膚科医院(佐賀)、佐賀県立病院好生館(佐賀)、佐賀市立富士大和温泉病院(佐賀)、関東労災病院 (神奈川)、長崎北病院(長崎)、ヨゼフクリニック(長崎)、長崎市立市民病院(長崎)、寺沢病院(徳島)、徳島市民病院(徳島)、高木病院(福岡)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2010 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2014 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 01 Day
Last modified on
2017 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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