UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007078 |
|---|---|
| Receipt number | 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 11:00:32 |
* 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
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
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
m_tackey@hotmail.com
Sponsor or person
Institute
Yokohama City Unuversity School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008335
