UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028293 |
|---|---|
| Receipt number | 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 18:22:37 |
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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
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
tomonaka@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032392
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