UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023414 |
|---|---|
| Receipt number | R000026974 |
| Scientific Title | The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2017/10/06 13:44:22 |
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Basic information
Public title
The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study
Acronym
ANGLE study
Scientific Title
The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study
Scientific Title:Acronym
ANGLE study
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 compare the results of measurements of plasma glucagon by ELISA and LC-MS/MS during meal tests in type 2 diabetes mellitus treated with anagliptin
Basic objectives2
Others
Basic objectives -Others
Evaluation of levels of active GIP, active GLP-1, and total GLP-1 before and after
anagliptin administartion
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of results by measurement methods (ELISA and LC-MS/MS) for delta AUC0-180min (plasma glucagon) before and after anagliptin administration
Key secondary outcomes
1.Comparison of results by measurement methods (ELISA and LC-MS/MS) for delta plasma glucagon (from 0min to each measurement point) before and after anagliptin administration
2.Comparison of results by measurement methods (ELISA and CC-MS/MS) for delta AUC0-120min (plasma glucagon) before and after anagliptin administration
3.Evaluation of correlations between the
results by two methods (ELISA and LC-MS/MS) at each measurement point before and after anagliptin administration
4.Comparisons of changes of the following parameters from baseline to 4 weeks
(active GIP, active GLP-1, total GLP-1, C-peptide and plasma glucose)
5.Comparisons of the levels of active GIP, active GLP-1, and total GLP-1 at baseline and 4 weeks
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
4-weeks treatment by anagliptin 200mg
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. Outpatients with type 2 diabetes
mellitus
2. 20 years of age or over
3. HbA1c with 7.0% to 10.9%
4. No change of anti-diabetes drugs
within 8 weeks before acquirung
consent
5. Patients treated with up to 3 drugs of
biguanide, thiazolidine, glinide,
sulfonylurea, SGLT2 inhibitor,
alpha-glucosidase inhibitor in
addition to insulin
Key exclusion criteria
1. Type 1 diabetes
2. patients with change of insulin of 4
unit and more within observation period
3. patients with change of kinds of
insulin within observation period
4. patients previously treated with
anagliptin
5. BMI of 30 and more
6. severe liver disease (AST or ALT 100IU/
L and more)
7. severe kidney disease or serum
creatinine of 1.5mg/dl and more
8. severe heart failure or patients with
attacks of myocardial infarction and
angina
9. patients with stroke within 24 weeks
before acquirung consent
10.patients with malignancy
11.severe diabetic complications
(neuropathy, retinopathy, nephropathy)
12.severe ketosis including diabetic coma
13.anemia (Hb < 9.5g/dl)
14.enteropathy with abnormal digestion
and absorption
15.patients with past history of
gastrointestinal resection
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kanazawa |
Organization
Juntendo University
Division name
Department of Metabolism & Endocrinology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
akana@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Kanazawa |
Organization
Juntendo University
Division name
Department of Metabolism & Endocrinology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
akana@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
SANWA KAGAKU KENKYUSYO CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 31 | Day |
Last modified on
| 2017 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026974
