UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000014531
Receipt No. R000014762
Scientific Title The effects of anaglipitin, a DPP-4 inhibitor, on blood lipids in type 2 diabetic patients.
Date of disclosure of the study information 2014/07/11
Last modified on 2020/04/06 (Ver. 9)

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Basic information
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
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Blood lipid fractions
Key secondary outcomes

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization Sanwa Kagaku Kenkyu-sho
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 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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 名古屋大学医学部附属病院、海南病院

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 11 Day

Related information
URL releasing protocol https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0228004
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2014 Year 07 Month 10 Day
Last modified on
2020 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014762