UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effect of Anagliptin administration on the activity of glucagon after test meal loading
Title of the study (Brief title)	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	Shu Yanagisawa
Organization	Arc Cardiovascular Clinic
Division name	Arc Cardiovascular Clinic
Address	Aza yachioki26-1, Hiromote, Akita-shi, Akita, Japan
TEL	018-831-3311
Email	arc-irg@sa-tt.co.jp

Public contact
Name of contact person	Shu Yanagisawa
Organization	Arc Cardiovascular Clinic
Division name	Arc Cardiovascular Clinic
Address	Aza yachioki26-1, Hiromote, Akita-shi, Akita, Japan
TEL	018-831-3311
Homepage URL
Email	arc-irg@sa-tt.co.jp

Sponsor
Institute	Arc Cardiovascular Clinic
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024323