UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021953 |
|---|---|
| Receipt number | R000025287 |
| Scientific Title | Differences about effectiveness of CGM and treatment satisfaction between dulaglutide and omarigliptin. |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2024/10/27 19:50:33 |
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Basic information
Public title
Differences about effectiveness of CGM and treatment satisfaction between dulaglutide and omarigliptin.
Acronym
Effectiveness of CGM and DTSQ with dulaglutide or omarigliptin.
Scientific Title
Differences about effectiveness of CGM and treatment satisfaction between dulaglutide and omarigliptin.
Scientific Title:Acronym
Effectiveness of CGM and DTSQ with dulaglutide or omarigliptin.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study about effectiveness of continuous glucose monitor (CGM) and treatment satisfaction, we evaluate blood glucose transition with CGM for more than 7 days. The patients would be treated with dulaglutide and omarigliptin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose transition (standard deviation and MAGE) by CGM, average blood glucose level, Diabetes Treatment Satisfaction: DTSQ
Key secondary outcomes
glycoalbumin, the total time that blood glucose level monitored by CGM is less than 70mg/dL, body weight, systolic pressure, diastolic pressure, urine albumin creatinine ratio, C-peptide.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
In both groups, we stop the treatment of DPP-4i or GLP-1 receptor agonists if the patients are treated with them, but we continue the treatment with other antidiabetic drugs.
Only this group, No pharmaceutical intervention for 4 weeks, omarigliptin 25 mg/week for 5 weeks, no pharmaceutical intervention for 4 weeks, dulaglutide 0.75 mg/week for 5 weeks and no pharmaceutical intervention for 1 week.
In both groups, patients are equipped with a CGM (iPro2 Enlite Sensor by Medtronic) for 7 days from the 3th week after starting study and for 14 days from at 25th day (3 days before 5th treatment) after treatment with each medicine. We conduct DTSQ at the 4th week after starting study and treatment with each medicine. At the 4th week after starting study and treatment with each medicine, we measure these following values on an empty stomach, body weight, BMI, systolic pressure, diastolic pressure, HbA1c, glycoalbmin, serum AST, ALT, gamma-GTP, BUN, UA, eGFR, urine albumin creatinine ratio(mg/gCr), LDL-C, HDL-C, TG, glucose level, insulin, C-peptide. Office clerks enter inspection data, rather than a doctor.
Interventions/Control_2
No pharmaceutical intervention for 4 weeks, dulaglutide 0.75 mg/week for 5 weeks, no pharmaceutical intervention for 4 weeks, omarigliptin 25 mg/week for 5 weeks and no pharmaceutical intervention for 1 week.
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Out-patients with type 2 diabetes whose HbA1c is more than 6.5% and less than 15% and who has no changes of diabetic treatment (e.g. diet therapy, exercise cure, medication) within the past 12 weeks.
Key exclusion criteria
1. Patients who has renal dysfunction (eGFR is less than 30ml/min/1.73m2)
2. Pregnant women
3. Patients judged by the doctor to be ineligible
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Tosaki |
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name
Diabetes and Endocrinology
Zip code
4680009
Address
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL
052-800-2333
nrd49075@nifty.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Tosaki |
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Division name
Diabetes and Endocrinology
Zip code
468-0009
Address
2-1007 Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
TEL
052-800-2333
Homepage URL
nrd49075@nifty.com
Sponsor or person
Institute
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology Ethics Committee
Address
Motoueda, Tenpaku-ku, Nagoya City 468-0009, Japan
Tel
0528002333
secretary@tosaki.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
医療法人TDE 糖尿病・内分泌内科クリニックTOSAKI (愛知県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201802267412121267
Publication of results
Published
Result
URL related to results and publications
https://jglobal.jst.go.jp/detail?JGLOBAL_ID=201802267412121267
Number of participants that the trial has enrolled
7
Results
Examination of the effects of dulaglutide and omarigliptin using two-week continuous CGM and patient satisfaction with treatment: A crossover study
Results date posted
| 2024 | Year | 10 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty outpatients aged 15 to 85 years who were diagnosed with diabetes and had HbA1c levels between 6.5% and 15%, and who had not made any changes to their diabetes treatment (diet, exercise, or drug therapy) in the past 12 weeks.
Participant flow
A crossover comparative study in which participants were randomly divided into two groups after a 4-week observation period without drug intervention:
Group A: OM 25 mg for 5 weeks, no intervention for 4 weeks, DU 0.75 mg for 5 weeks, no intervention for 1 week
Group B: DU and OM swapped in Group A.
If participants were taking DPP-4 inhibitors or GLP-1 receptor agonists before the study, they were discontinued, but other diabetes medications were continued at the same dose during the period.
All groups wore a CGM (iPro2) for 7 days from 3 weeks into the observation period, and for 14 days from 25 days after OM or DU administration (3 days before the 5th and final administration).
- After 4 weeks of the observation period and 4 weeks after administration of OM or DU, the DTSQ was performed and weight, BMI, systolic blood pressure, diastolic blood pressure, HbA1c, glycoalbumin (GA), Cr, eGFR, urinary albumin/creatinine ratio, blood glucose level, blood insulin, and C-peptide were measured.
Adverse events
nothing
Outcome measures
While administering either omarigliptin or dulaglutide, the effect weakened 8-10 days after administration, but the blood glucose lowering effect tended to remain, as seen in CGM.
Dulaglutide had a significantly stronger blood glucose lowering effect and blood glucose fluctuation suppression effect than omarigliptin.
There was no significant change in patient satisfaction.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 05 | 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
| 2016 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025287
