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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034866
Receipt No. R000020069
Scientific Title Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes; a randomized, prospective, open-label clinical study
Date of disclosure of the study information 2019/01/04
Last modified on 2019/02/26

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Basic information
Public title Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes; a randomized, prospective, open-label clinical study
Acronym Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes (DIET)
Scientific Title Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes; a randomized, prospective, open-label clinical study
Scientific Title:Acronym Dietary impacts on glucose-lowering effects of sitagliptin in type 2 diabetes (DIET)
Region
Japan

Condition
Condition Diabetes Mellitus, Type 2
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In a prospective, randomized case-controlled study, the investigators hope to demonstrate a positive correlation of plasma levels of EPA and DHA as well as fish intake with the HbA1c-lowering effect of sitagliptin but not with the active comparator glimepiride.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Correlation of plasma levels of EPA and DHA with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride
Key secondary outcomes Correlation of estimated fish intake with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride.

Identification of blood metabolite correlating with changes in HbA1c levels from baseline to week 16 in each treatment group with sitagliptin and glimepiride.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Sitagliptin: Januvia 50 mg a day for 16 weeks
Interventions/Control_2 Glimepiride: Amaryl 0.5 mg a day for 16 weeks
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Japanese T2DM patient
2.OAD naive or receive 4-week wash out of one OAD (glinides, alpha-GI, metformin) before randomization
3. HbA1c 6.0-8.0 %
4. BMI 18 - 30 kg/m2
5. Age 20 - 75 years
8. CrCl 60mL/min or above
Key exclusion criteria 1.Patients on DPP-4 inhibitors or glimepiride
2.Patients treated with pioglitazone within the last 8 weeks
3.Patients with moderate/severe renal impairments (CrCl < 60mL/min)
4. Patients with insulin or GLP-1 receptor agonists
5. Patients with a history ofcerebrovascular disorder or cardiovascular disturbance
Patients with heart failure (NYHA I-IV)
6. Patients with severe hepatic dysfunction
7. Patients with a history of pancreatitis
8. Patients with diabetic retinopathy
9. Patients with a history of gastrointestinal surgery
10. Patients with a history of malignancy within the last 5 yrs
11. Patients with severe infection, severe injury or before/after operation
12. Patients with excessive drinking habit
13. Male Hb < 13.0 g/dl, Female Hb < 12.5 g/dl
14. Patients with a difficulty to follow instructions by investigators
15. Patients participating in any other clinical study
16. Pregnancy
17. Patients judged ineligible by investigators
Target sample size 48

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yutaka Seino
Organization Kansai Electric Power Hospital
Division name Center for Diabetes, Endocrinology and Metabolism
Zip code
Address 2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL 06-6458-5821
Email seino.yutaka@e2.kepco.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Daisuke Yabe
Organization Kansai Electric Power Hospital
Division name Center for Diabetes, Endocrinology and Metabolism
Zip code
Address 2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL 06-6458-5821
Homepage URL
Email ydaisuke-kyoto@umin.ac.jp

Sponsor
Institute Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization MSD K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Saiseikai Noe Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02312063
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 関西電力病院(大阪府)、大阪府済生会野江病院(大阪府)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We found that the 16-week HbA1c change in the sitagliptin group, but not in the glimepiride group, was associated with baseline EPA.
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 Completed
Date of protocol fixation
2014 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We found no associations of the HbA1c changes with estimated intake of seafoods, while we found negative associations with intake of potatoes and seaweeds. None of the food categories showed associations with the 16-week HbA1c change in the glimepiride group.

Management information
Registered date
2018 Year 11 Month 12 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020069

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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