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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028293
Receipt No. R000032392
Scientific Title Effect of anagliptin on plasma glucagon levels determined by LC-MS/MS in patients with type 2 diabetes
Date of disclosure of the study information 2018/10/01
Last modified on 2019/02/26

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Basic information
Public title Effect of anagliptin on plasma glucagon levels determined by LC-MS/MS in patients with type 2 diabetes
Acronym Effect of anagliptin on plasma glucagon levels determined by LC-MS/MS
Scientific Title Effect of anagliptin on plasma glucagon levels determined by LC-MS/MS in patients with type 2 diabetes
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasushi Tanaka
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Tomoko Nakagawa
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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