UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029288 |
|---|---|
| Receipt number | R000033477 |
| Scientific Title | To evaluate the efficacy and safety of once-weekly DPP-4 inhibitor: Omarigliptin and the differences between Omarigliptin and once or twice-daily DPP-4 inhibitors for the treatment of type 2 diabetes |
| Date of disclosure of the study information | 2017/09/29 |
| Last modified on | 2020/09/23 18:23:07 |
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Basic information
Public title
To evaluate the efficacy and safety of once-weekly DPP-4 inhibitor: Omarigliptin and the differences between Omarigliptin and once or twice-daily DPP-4 inhibitors for the treatment of type 2 diabetes
Acronym
To evaluate the efficacy of Omarigliptin and the differences between Omarigliptin and daily DPP-4 inhibitors
Scientific Title
To evaluate the efficacy and safety of once-weekly DPP-4 inhibitor: Omarigliptin and the differences between Omarigliptin and once or twice-daily DPP-4 inhibitors for the treatment of type 2 diabetes
Scientific Title:Acronym
To evaluate the efficacy of Omarigliptin and the differences between Omarigliptin and daily DPP-4 inhibitors
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of once-weekly DPP-4 inhibitor, Omarigliptin, and to discuss the differences between Omarigliptin and once or twice-daily DPP-4 inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fasting blood glucose and IRI are set to be measured at baseline, 3, 6, 9, 12 months.
Key secondary outcomes
Body mas index (BMI), blood pressure, albumin-creatinine ratio (ACR), lipid and liver function are set to be measured at baseline, 3, 6, 9, 12 months
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
Active treatment with Omarigliptin 25mg once-weekly for 12 months
Interventions/Control_2
Active treatment with Daily-DPP4 inhibitor for 12 months
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients
Key exclusion criteria
1)eGFR<30
2)Having had side effects of another DPP-4inhibitors before
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Hattori |
Organization
Foundation Health Medicine Association Tohto Clinic
Division name
Diabetes Internal Medicine
Zip code
102-0094
Address
4-1 Kioi-Cho, Chiyoda-ku, Tokyo 102-0094 Japan
TEL
03-3239-0301
s-hattori@kenkoigaku.or.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Hattori |
Organization
Foundation Health Medicine Association Tohto Clinic
Division name
Diabetes Internal Medicine
Zip code
102-0094
Address
4-1 Kioi-Cho, Chiyoda-ku, Tokyo 102-0094 Japan
TEL
03-3239-0301
Homepage URL
s-hattori@kenkoigaku.or.jp
Sponsor or person
Institute
Diabetes Internal Medicine, Tohto Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Thoto clinic
Address
1-4 Kioi-cho Chiyoda-ku Tokyo
Tel
03-3229-0301
rinri-tohto@kenkoigaku.or.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-020-00533-3#Sec2
Publication of results
Published
Result
URL related to results and publications
https://dmsjournal.biomedcentral.com/articles/10.1186/s13098-020-00533-3#Sec6
Number of participants that the trial has enrolled
84
Results
Omarigliptin tended to elicit reductions in FBG, LDL-C, TG, AST, ALT, gamma-GTP, ACR with log ACR, and SBP and DBP, but the differences did not reach statistical significance compared with control. Values for HDL-C tended to increase, but also did not reach statistical significance compared with control. Omarigliptin significantly decreased HOMA-IR, RLP-C, and hsCRP with log hsCRP compared with control. However, omarigliptin did not affect HbA1c, BMI, and eGFR.
Results date posted
| 2020 | Year | 09 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This single-center, open-label, randomized, prospective study included 84 patients who have attended our clinic for at least 12 months and had hemoglobin A1c (HbA1c) > 6.0% regardless of diet, exercise, and daily medication with the DPP4 inhibitors sitagliptin (50 mg) or linagliptin (5 mg). The patients were allocated in a 1:2 ratio using numbered containers to continue the same daily regimens of sitagliptin 50 mg (n = 19) or linagliptin 5 mg (n = 9) as a control group (n = 28) or to switch from these inhibitors (n = 40 and n = 16, respectively) to omarigliptin 25 mg/week (omarigliptin group: n = 56).
Participant flow
Patients were allocated to continue with daily DPP4 inhibitors (control, n = 28) or to switch from daily DPP4 inhibitors to weekly omarigliptin (omarigliptin, n = 56). Fasting blood and urine samples were collected before, and every 3 months after intervention for 1 year.
Adverse events
None.
Outcome measures
Blood and urine samples were collected from all included patients after an overnight fast at baseline and then at intervals of 3 months for 1 year. Values for hsCRP, IRI, RLP-C, and urinary albumin were assessed at LSI Medicine Corporation (Tokyo, Japan). Other biochemical data were generated in-house. HOMA-IR was calculated as (FBG * IRI)/450. The primary and secondary endpoints were changes among HbA1c, BMI, hsCRP, and HOMA-IR between baseline and 1 year later, and between baseline and 3-month intervals in the control and omarigliptin groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033477
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