UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study
Title of the study (Brief title)	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	Akio Kanazawa
Organization	Juntendo University
Division name	Department of Metabolism & Endocrinology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	akana@juntendo.ac.jp

Public contact
Name of contact person	Akio Kanazawa
Organization	Juntendo University
Division name	Department of Metabolism & Endocrinology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	akana@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026974