UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024399
Receipt No. R000028082
Scientific Title The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study
Date of disclosure of the study information 2016/10/13
Last modified on 2018/04/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study
Acronym The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin (ANGLE study)
Scientific Title The study of ANagliptin effects on Glucagon LEvels of type 2 DM patients using insulin / ANGLE study
Scientific Title:Acronym 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
1st name
Middle name
Last name Akio Kanazawa
Organization Juntendo University Hospital
Division name Department of Metabolism and Endocrinology
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email akana@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 13 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
2016 Year 07 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000028082

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.