UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021102 |
|---|---|
| Receipt number | R000024323 |
| Scientific Title | Study of the effect of Anagliptin administration on the activity of glucagon after test meal loading |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/06/18 11:45:30 |
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Basic information
Public title
Study of the effect of Anagliptin administration on the activity of glucagon after test meal loading
Acronym
Study of the effect of Anagliptin administration on the activity of glucagon after test meal loading
Scientific Title
Study of the effect of Anagliptin administration on the activity of glucagon after test meal loading
Scientific Title:Acronym
Study of the effect of Anagliptin administration on the activity of glucagon after test meal loading
Region
| Japan |
Condition
Condition
Patients with type II diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to investigate the significance of glucagon suppression by DPP-4 inhibitor action, through measuring post-test meal glucagon levels before and after Anagliptin administration in patients with type II diabetes mellitus. Furthermore, glucagon levels will be measured using a newly developed kit.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in glucagon AUC0-2h during test meal loading one month after Anagliptin administration
Key secondary outcomes
Change in all types of parameters during test meal loading before and after Anagliptin administration.
(1)Glucagon level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h)
(2)Blood glucose level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h, AUC0-2h)
(3)Insulin level (fasting, 30 min, 60 min, 120 min, incremental AUC0-2h, AUC0-2h)
(4)C-peptide (fasting, delta 0-30 min, incremental AUC0-1h, incremental AUC0-2h)
(5)Insulin/glucagon ratio
Changes in laboratory test results before and after Anagliptin administration
AST(GOT), ALT(GPT), gamma-GTP, serum creatinine, total cholesterol, LDL-cholesterol (formula), HDL-cholesterol, triglyceride, HbA1c
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prescription of oral Anagliptin 100 mg twice daily, morning and night. Furthermore, if the effect is insufficient, the dose can be increased up to 200 mg as required, under supervision.
The period of administration for the study medication will be 1 month (+/-2 weeks) after the first test meal loading.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with a diagnosis of type II diabetes mellitus
2) HbA1c less than 10.0%
3) Fluctuation range within +/-1.0% for the previous two HbA1c levels
4) Patients 20 years of age and older (regardless of gender)
5) Patients using DPP-4 inhibitors (limited to single daily dose preparations) other than Anagliptin
6) Patients who have provided written consent for participation in this study
Key exclusion criteria
1) Patients with a history of hypersensitivity to the components of Anagliptin
2) Patients with severe ketosis, diabetic coma or pre-coma, or type I diabetes mellitus
3) Patients with severe infection or severe trauma, and pre- or post-operative patients
4) Patients with severe renal impairment or on dialysis with end-stage renal failure
5) Patients with a history of abdominal surgery (limited to gastrointestinal surgery) or intestinal obstruction
6) Women who are currently pregnant or may be pregnant, or women who are currently breastfeeding
7) Patients who are currently on continual insulin preparations or have been determined to require insulin preparations
8) Patients who are currently using GLP-1 receptor agonist medication or have been determined to require GLP-1 receptor agonist medication
9) Patients who may have allergy to wheat or eggs
10) Patients who may have difficulty conducting the test meal loading (no alcohol the previous day, 10 hours fasting, etc.)
11) Patients determined to be unsuitable for participation in the study by the research investigators or sub-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shu Yanagisawa |
Organization
Arc Cardiovascular Clinic
Division name
Arc Cardiovascular Clinic
Zip code
Address
Aza yachioki26-1, Hiromote, Akita-shi, Akita, Japan
TEL
018-831-3311
arc-irg@sa-tt.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shu Yanagisawa |
Organization
Arc Cardiovascular Clinic
Division name
Arc Cardiovascular Clinic
Zip code
Address
Aza yachioki26-1, Hiromote, Akita-shi, Akita, Japan
TEL
018-831-3311
Homepage URL
arc-irg@sa-tt.co.jp
Sponsor or person
Institute
Arc Cardiovascular Clinic
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
アーク循環器クリニック（秋田県）、御所野ひかりクリニック（秋田県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | 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
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
| 2016 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2018 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024323
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
