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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007078
Receipt No. R000008335
Scientific Title Comparative study of sitagliptin, vildagliptin and alogliptin in patients with type 2 diabetes inadequately controlled with metformin and/or sulfonylurea: a randomized, open labeled trial.
Date of disclosure of the study information 2012/01/16
Last modified on 2014/07/16

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Basic information
Public title Comparative study of sitagliptin, vildagliptin and alogliptin in patients with type 2 diabetes inadequately controlled with metformin and/or sulfonylurea: a randomized, open labeled trial.
Acronym Comparison of sitagliptin, vildagliptin and alogliptin.
Scientific Title Comparative study of sitagliptin, vildagliptin and alogliptin in patients with type 2 diabetes inadequately controlled with metformin and/or sulfonylurea: a randomized, open labeled trial.
Scientific Title:Acronym Comparison of sitagliptin, vildagliptin and alogliptin.
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to compare the efficacy and tolerability of sitagliptin, vildagliptin and alogliptin in patients with type 2 diabetes inadequately controlled with
metformin and/or sulfonylurea.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes FPG and HbA1c at 0, 8, 16 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin.
Key secondary outcomes TG, LDL-C, HDL-C, body weight, fasting insulin and glucagon at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin.

AST, ALT,gamma-GTP, fibrinogen and type 4 collagen 7S at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin.

BUN, Cr, e-GFR, microalbuminuria and cystatin C at 0 and 24 weeks after administration of sitagliptin, vildagliptin or alogliptin.

Frequency of adverse effects such as hypoglycemia and gastrointestinal symptom after administration of sitagliptin, vildagliptin or alogliptin.

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with sitagliptin (50mg/day). Collection of blood and urine at 0, 8, 16 and 24 weeks after administration of the agent.
Interventions/Control_2 Treatment with vildagliptin (100mg/day). Collection of blood and urine at 0, 8, 16 and 24 weeks after administration of the agent.
Interventions/Control_3 Treatment with alogliptin (25mg/day). Collection of blood and urine at 0, 8, 16 and 24 weeks after administration of the agent.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients who were inadequately controlled (HbA1c (JDS) 6.5~9.0%) with metformin alone, sulfonylurea alone, or metformin and sulfonylurea.
Key exclusion criteria 1.Patients with history of diabetic ketoacidosis or diabetic coma within 6 months prior to the study recruitment.
2.Patients with history of cardiac failure.
3.Patients who received surgical operation during the study.
4.Patients with severe infection or severe trauma.
5.Patients during pregnancy or lactation.
6.Patients with renal insufficienc(serum reatinine > 1.5mg/dl, e-GFR < 30ml/min).
7.Patients with severe liver
dysfunction.
8.Patients who received insulin therapy.
9.Patients with history of hypersensitive reaction to sitagliptin, vildagliptin or alogliptin.
10.Patients determined to be inappropriate by physician.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Yokohama City Unuversity School of Medicine
Division name Department of Endcrinology & Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-Ku, Yokohama City 236-0004
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Takihata
Organization Yokohama City Unuversity School of Medicine
Division name Department of Endcrinology & Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-Ku, Yokohama City 236-0004
TEL 0457872800
Homepage URL
Email m_tackey@hotmail.com

Sponsor
Institute Yokohama City Unuversity School of Medicine
Institute
Department

Funding Source
Organization Yokohama City Unuversity School of Medicine
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

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 16 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 01 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 16 Day
Last modified on
2014 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008335

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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