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 UMIN000008155
Receipt No. R000009606
Scientific Title Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Date of disclosure of the study information 2012/06/13
Last modified on 2013/06/13

* 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 Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Acronym Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Scientific Title Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Scientific Title:Acronym Effect of DPP-4 inhibitor or Metformin on insulin therapy in patients with type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 The study aims to examine effects of DPP-4 inhibitor "Sitagliptin" or biguanide "Metforimin" on glucose metabolism and it`s related factors (glucagon, C-peptide) in patients with type 2 diabetes who are inadequately controlled blood glucose level treated by insulin mono-therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Change of glucose, glucagon and C-peptide response to MTT after sitagliptin or metformin treatment.
Key secondary outcomes Change of HbA1c, fasting plasma glucose, glucagon and C-peptide after sitagliptin or metforimin treatment.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sitagliptin
Interventions/Control_2 metformin
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with type 2 daiabetes
2) Patients without change of treatment for the past three months
3) HbA1c(NGSP) 6.9%<=and10.5%>
4) Over 20 years old,Under 75 years old
5) A consent form for participating in this study is submitted
6) Possible to take the test meal (a set of Chicken in white sauce, crackers, soft pudding)

Key exclusion criteria 1) Patients with glucagnoma
2) Patients who started in the cure for the past three months
3) Patients who changed in the cure for the past three months
4) Patients with type 1 diabetes.Patients with type 2 diabetes HbA1c>=10.5% or severe ketosis,diabetic coma.
5) Patients treated with oral hypoglycemic agents
6) Patients with nephrosic syndrome
7) Patients treated with steroid, immune-suppressive agent and azole antifungal
8) Patients with allergy against sitagliptin and metformin
9)Patients with exceeding the moderate renal impairment (sCr: male>=1.3mg/dl, female>=1.2mg/dl).
10)Patients with exceeding the moderate liver dysfunction (AST,ALT>3 times upper standard value).
11)Patients who are pregnant, breast-feeding and/or intention to become pregnant
12)Other patients determined to be inappropriate by physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Nakazaki
Organization Itabashi Hospital, Nihon University School of Medicine
Division name Divison of Diabetes and Metabolism
Zip code
Address 30-1 Oyaguchi kamicho, Itabashi-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Itabashi Hospital, Nihon University School of Medicine
Division name Divison of Diabetes and Metabolism
Zip code
Address 30-1 Oyaguchi kamicho, Itabashi-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Divison of Diabetes and Metabolism,Itabashi Hospital, Nihon University School of Medicine
Institute
Department

Funding Source
Organization none
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 日本大学医学部附属板橋病院糖尿病代謝内科

Other administrative information
Date of disclosure of the study information
2012 Year 06 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
2012 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2012 Year 06 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
2012 Year 06 Month 13 Day
Last modified on
2013 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009606

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.