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)	The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin (ANGLE study)
Region	Japan

Condition
Condition	Type 2 diabetes Mellitus (T2DM)
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare and examine plasma glucagon values between those measured by the conventional method and LC-MS/MS method; those are tested undergoing a meal tolerance test after using anagliptin in T2DM patients with insulin treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of plasma glucagon AUC 0-180 min before and after using anagliptin (the conventional and LC-MS/MS methods)
Key secondary outcomes	1. Change of plasma glucagon from the time before breakfast at each observation point before and after using anagliptin (the conventional and LC-MS/MS methods) 2. Change of plasma glucagon AUC 0-120 min before and after using anagliptin (the conventional and LC-MS/MS methods) 3. Correlation between glucagon values measured by the conventional and LC-MS/MS methods 4. Changes from the time before breakfast at each observation point in GIP and GLP-1 active form in plasma, total GLP-1, precision serum C-peptide, and glucose 5. Comparisons of the following items between baseline and the week 4: GIP and GLP-1 active form in plasma, total GLP-1, precision serum C-peptide, glucose, body weight and blood pressure. Frequencies of adverse events (including abnormal values in clinical examinations)

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	* Orally take a dose of 100 mg of anagliptin twice a day in the morning and evening in addition to the medicines taken at time of consenting * If patients are at a risk of hypoglycemia, start with anagliptin with reduced amount of sulfonylurea medicines
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	Patients who meet all of the following criteria are included in this study. 1. Patients who was diagnosed as T2DM 2. At age of 20 or older at time of giving consent 3. HbA1c 7% or higher, and below 11% with less than 1% changes within 12 weeks prior to patients provide consent 4. Patients without any changes (adding, suspending, or changing doses) in their treatment for T2DM (excluding insulin dosage changes) within 8 weeks prior to giving their consent 5. In addition to insulin, no more than three medications from the following are used: biguanide, sulfonylurea and thiazolidinedione medicines, rapid-acting insulin secretion promoter, SGLT2 and alpha-glucosidase inhibitors 6. Patients who are on diet and physical exercise therapies 7. Outpatients 8. Female or male 9. Patients who are capable of making a decision by themselves, and can provide written consent
Key exclusion criteria	Patients who fall into any of the following criteria are unable to participate in the study. 1. Patients with type 1 diabetes mellitus 2. Patients with insulin dose increased 4 units during the observation times [-12 weeks from baseline] 3. Patients with kind of insulin preparation changed during the observation times 4. Patients who have an experience of taking anagliptin in the past 5. Patients with BMI 30 kg/m2 or greater 6. Patients with severe liver impairment (e.g. decompensated cirrhosis), or either AST or ALT 100 IU/L or higher during the observation times 7. Patients with severe renal impairment (e.g. renal failure), or serum creatinine 1.5 mg/dL or higher during the observation times 8. Patients with severe heart impairment (e.g. heart failure, unstable angina), or have myocardial infarct or angina attack within 24 weeks of the observation times 9. Stroke (cerebral infarction, brain hemorrhage) within 24 weeks before providing consent 10. Patients with malignancy 11. Patients with severe diabetic complications (neuropathy, retinopathy, and nephropathy) 12. Patients with severe ketosis, diabetic coma or precoma 13. Patients with endocrine disease which needs more than hormone replacement therapy (e.g. pituitary, thyroid, or adrenal disease) 14. Patients who have moderate to severe anemia (hemoglobin is below 9.5g/dL) 15. Patients with intestine disease which shows abnormality in digestion and absorption 16. Patients with a medical history digestive organ ablation (excepting cutting appendix) 17. Patients who are excessive alcohol drinkers (e.g. an average of 3 Go of Japanese wine, or 3 large bottles of beer, or more) 18. Patients with other reasons that the responsive investigators or other investigators think inappropriate to participate
Target sample size	20

Research contact person
Name of lead principal investigator	Akio Kanazawa
Organization	Juntendo University Hospital
Division name	Department of Metabolism and Endocrinology
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	akana@juntendo.ac.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Address	NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Juntendo University Hospital
Institute
Department

Funding Source
Organization	SANWA KAGAKU KENKYUSHO 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	2016 Year 10 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 28 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 13 Day
Last modified on	2018 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028082