UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034866 |
|---|---|
| Receipt number | 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 18:26:59 |
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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
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
seino.yutaka@e2.kepco.co.jp
Public contact
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
ydaisuke-kyoto@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020069
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| Registered date | File name |
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