UMIN-CTR Clinical Trial

Public title

The effects of anaglipitin, a DPP-4 inhibitor, on blood lipids in type 2 diabetic patients.

Acronym

Anagliptin effects on lipids (ANGELS)

Scientific Title

The effects of anaglipitin, a DPP-4 inhibitor, on blood lipids in type 2 diabetic patients.

Scientific Title:Acronym

Anagliptin effects on lipids (ANGELS)

Region

Japan

Condition

Type 2 Diabetes Mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to calryify the effects of anagliptin, a DPP-4 inhibitor, on blood lipids in type 2 diabetic patiens and also to investigate its mechanisms.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Blood lipid fractions

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Anagliptin

Interventions/Control_2

Anti-diabetic agents except DPP4 inhibitors

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

Type 2 diabetes
HbA1c >= 6.5%
Serum LDL >= 120 mg/dl
No DPP4 inhibitors for latest 3 months
No antidiabetic medication or no change in medication for the latest 3 months
20 y.o. or older
Written agreement is obtainable from the patient

Key exclusion criteria

Type 1 diabetes
Treatment with insulin, glinides, high doses of SU
Patients with repetitive or unaware severe hypoglycemia
Severe liver diseases
Patients with hemodialysis
Severe cardiac diseases or acute myocardial infarction within 6 months
Severe anemia
Severe pancreatitis
Malignant diseases
Uncontrolled endocrine diseases
Severe infections or surgical treatment
Severe diabetic complications
Severe bowel diseases
Alcohol addiction
Pregnant or possibly pregnant women
History of allergic reaction to DPP4 inhibitors
Patients who a physician-in-charge considers is unsuitable for the trial.

Target sample size

60

Name of lead principal investigator

1st name	Hiroshi
Middle name
Last name	Arima

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Endocrinology and Diabetes

Zip code

466-0065

Address

65 Tsuruma-cho, Showa-ku, Nagoya 466-8550

TEL

0527442142

Email

t-onoue@med.nagoya-u.ac.jp

Name of contact person

1st name	Takeshi
Middle name
Last name	Onoue

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Endocrinology and Diabetes

Zip code

466-0065

Address

65 Tsuruma-cho, Showa-ku, Nagoya 466-8550

TEL

0527442142

Homepage URL

Email

t-onoue@med.nagoya-u.ac.jp

Institute

Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine

Institute

Department

Personal name

Organization

Sanwa Kagaku Kenkyu-sho

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Ethical Committee of the Nagoya University Graduate School of Medicine

Address

65 Tsuruma-cho, Showa-ku, Nagoya 466-8550

Tel

0527442142

Email

t-onoue@med.nagoya-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋大学医学部附属病院、海南病院

Date of disclosure of the study information

2014

Year

07

Month

11

Day

URL releasing protocol

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0228004

Publication of results

Unpublished

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0228004

Number of participants that the trial has enrolled

24

Results

Treatment with anagliptin for 24 weeks significantly reduced fasting serum apolipoprotein (Apo) B-48 compared with the control group (P < 0.05).

Results date posted

2020

Year

01

Month

31

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Type 2 diabetes Age 63.9 y.o. HbA1c 7.2%

Participant flow

36 candidates were eligible for this study at the initial screening, based on electronic medical records. 24 patients were recruited into the study, and were randomly assigned to the anagliptin (n =12) or control (n=12) group.

Adverse events

There were no severe adverse events related to interventions.

Outcome measures

serum lipids

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

02

Month

25

Day

Date of IRB

2014

Year

02

Month

25

Day

Anticipated trial start date

2014

Year

07

Month

11

Day

Last follow-up date

2018

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

07

Month

10

Day

Last modified on

2020

Year

04

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014762