UMIN-CTR Clinical Trial

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

Type 2 diabetes Mellitus (T2DM)

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Juntendo University Hospital

Institute

Department

Personal name

Organization

SANWA KAGAKU KENKYUSHO CO. LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

10

Month

13

Day

Last modified on

2018

Year

04

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028082