UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of anagliptin on plasma glucagon levels determined by LC-MS/MS in patients with type 2 diabetes
Title of the study (Brief title)	Effect of anagliptin on plasma glucagon levels determined by LC-MS/MS
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of anagliptin on plasma glucagon levels determined by LC-MS/MS method.
Basic objectives2	Others
Basic objectives -Others	To compare the effect of anagliptin on inslin secretion and gastric emptying rate of by performing the [13C]-acetate breath test.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The change of the plasma glucagon AUC from baseline in the liquid test meal performed after 4 weeks.
Key secondary outcomes	The change of the plasma insulin and plasma glucose AUC from baseline in the liquid test meal performed after 4 weeks, and the change of Tlag and T1/2 from baseline in the liquid test meal performed after 4 weeks. And the change of HbA1c, glycoalbumin and fasting plasma glucose in the liquid test meal performed after 4 weeks.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients with lifestyle therapy or metformin monotherapy up to 1250 mg per day, and then are randomly assigned to add anagliptin 200 mg per day.
Interventions/Control_2	Patients with lifestyle therapy or metformin monotherapy up to 1250 mg per day, and then are randomly assigned to add metformin 1000 mg per day.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) age between 20 and 75 years at the time on giving consent, female or male, 2) inadequate glycemic control (HbA1c from 6.5% to 9.0% on giving consent, and variation of HbA1c by <0.5% within 3 months before recruitment), 3) body mass index less than 35 kg/m2, 4) duration of diabetes more than 1 years, and 5) current treatment for type 2 diabetes with lifestyle therapy or metformin monotherapy up to 1250 mg per day, 6)Patients who are capable of making a decision by themselves, and can provide written consent.
Key exclusion criteria	1) type 1 diabetes, 2) glucagonoma, 3) hospital admission to improve glycemic control within the past 1 year on giving consent, 4) a history of coronary artery disease, coronary revascularization, stroke, or transient ischemic attacks within the past 1 year on giving consent, 5) a history of severe infectious disease within the past 1 year on giving consent, 6) malignancy, 7) severe renal dysfunction (estimated glomerular filtration rate < 45 mL/min/1.73 m2) or nephrotic syndrome, 8) severe liver dysfunction (AST, ALT greater than 3 times upper standard values), 9) being treated with steroids, immune-suppressive agents and/or azole antifungal medication, beta blocker, 10) women who were pregnant, possibly pregnant, planned to become pregnant, or were breast-feeding, 11) a history of gastric and duodenal operation, and 12) other patients who were considered to be ineligible for the study by the attending doctor, 13) the use of any investigational drug within 12 weeks on giving consent, 14) Insulin-dependent type 2 diabetes, 15) allergy for anagliptin and metformin, 16) Patients with any changes in their oral diabetes medicine for type 2 diabetes within 12 weeks prior to giving consent.
Target sample size	24

Research contact person
Name of lead principal investigator	Yasushi Tanaka
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan.
TEL	044-977-8111
Email	smu.tainai@gmail.com

Public contact
Name of contact person	Tomoko Nakagawa
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan.
TEL	044-977-8111
Homepage URL
Email	tomonaka@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
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	聖マリアンナ医科大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 20 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2018 Year 10 Month 10 Day
Date trial data considered complete	2018 Year 10 Month 31 Day
Date analysis concluded	2018 Year 11 Month 20 Day

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

Management information
Registered date	2017 Year 07 Month 20 Day
Last modified on	2019 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032392