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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011256
Receipt No. R000013194
Scientific Title The effects of anagliptin on plasma lanosterol, sitosterol, campesterol level in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2013/08/05
Last modified on 2014/09/18

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Basic information
Public title The effects of anagliptin on plasma lanosterol, sitosterol, campesterol level in patients with type 2 diabetes mellitus
Acronym The effects of anagliptin on lanosterol, sitosterol, campesterol
Scientific Title The effects of anagliptin on plasma lanosterol, sitosterol, campesterol level in patients with type 2 diabetes mellitus
Scientific Title:Acronym The effects of anagliptin on lanosterol, sitosterol, campesterol
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of anagliptin on LDL-C in patients with type 2 diabetes mellitus.
Basic objectives2 Others
Basic objectives -Others we also observed the effects of anagliptin alone on pre- and post-prandial (1, 2 hours) blood glucose, lipid, insulin, C-peptide and proinsulin, pre- and post-prandial (1 hours) active GLP-1 in participated patients after 6 months
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome is changes in LDL-cholesterol at 6 months.
Key secondary outcomes The secondary outcome is changes on plasma lanosterol, sitosterol, campesterol level in patients with type 2 diabetes mellitus

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Anagliptin 100mg-200mg x 2/day
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Type 2 diabetic patients, who has inadequate glycemic control, being treated with on diet and exercise or oral hypoglycemic agent
2) HbA1c<8.0%
3) More than 20 years (at the time of informed consent date)
4) Ability to provide written informed consent for this study
Key exclusion criteria 1) The patient who uses DPP-4 inhibitor
2) The patient who uses Insulin
3) The patient who uses glinide
4) The patient who uses GLP-1 receptor agonist
5) The patient with hypersensitivity for anagliptin
6) The patient with severe diabetic ketoacidosis, with diabetic coma/precoma or with type 1 diabetes
7) The patient with sepsis, before and after operation, severe trauma
8) The patient with severe renal dysfunction (SCr:more than 2.4mg/dL (male), 2.0mg/dL(female)), hemodialysis or peritoneal dialysis
9) Female patients who are pregnant, suspected of being pregnant
10) Any patients deemed by the investigator to be ineligible for participation in this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Inoue
Organization Saitama Medical Universit
Division name Department of Endocrinology and Diabetes
Zip code
Address 38 Morohongou, Moroyamacho, irumagun, Saitama Prefectur
TEL 049-279-1875
Email i1901018@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ikuo Inoue
Organization Saitama Medical University
Division name Department of Endocrinology and Diabetes
Zip code
Address 38 Morohongou, Moroyamacho, irumagun, Saitama Prefectur
TEL 049-279-1875
Homepage URL
Email i1901018@saitama-med.ac.jp

Sponsor
Institute Ikuo Inoue
Institute
Department

Funding Source
Organization Department of Endocrinology and Diabetes, Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
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 埼玉医科大学病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2013 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 05 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
2014 Year 08 Month 01 Day
Date trial data considered complete
2014 Year 09 Month 02 Day
Date analysis concluded
2014 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 23 Day
Last modified on
2014 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013194

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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