UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004716 |
|---|---|
| Receipt number | R000005612 |
| Scientific Title | Comparative study of sitagliptin with pioglitazone in Japanese type 2 diabetic patients |
| Date of disclosure of the study information | 2010/12/13 |
| Last modified on | 2012/09/03 10:02:24 |
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Basic information
Public title
Comparative study of sitagliptin with pioglitazone in Japanese type 2 diabetic patients
Acronym
the COMPASS randomized controlled trial
Scientific Title
Comparative study of sitagliptin with pioglitazone in Japanese type 2 diabetic patients
Scientific Title:Acronym
the COMPASS randomized controlled trial
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of these two agents and the presence of surrogate markers related to diabetic complications in Japanese type 2 diabetic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The difference in the mean changes in the HbA1c level from baseline at 24 weeks between these two groups.
Key secondary outcomes
the levels of fasting blood glucose, fasting insulin, inflammation mediators, N-terminal pro-B-type natriuretic peptide, and markers of lipids, uric acid, liver function and renal function.
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with sitagliptin (50 mg/day). At 16 weeks, if the HbA1c level was > 6.9%, the dose of sitagliptin was increased up to 100 mg/day.The maximum doses of glimepiride, glibenclamide, and gliclazide were 2 mg/day, 1.25 mg/day, and 40 mg/day, respectively. At 8, 16, and 24 weeks, if the FPG was < 70 mg/dL or symptomatic hypoglycemic symptoms were observed by the physicians, the dose of sulfonylurea was decreased gradually as follows: for glimepiride, 2 mg, 1 mg, 0.5 mg, and withdrawal; for glibenclamide, 1.25 mg, 0.625 mg, and withdrawal; and for gliclazide, 40 mg, 20 mg, 10 mg, and withdrawal.
Interventions/Control_2
Treatment with piogritazon (15 mg/day). At 16 weeks, if the HbA1c level was > 6.9%, the dose of pioglitazone was increased up to 30 mg/day. At 16 weeks, if the HbA1c level was > 6.9%, the dose of sitagliptin was increased up to 100 mg/day. The range of the metformin dose was 500-1500 mg/day, and the maximum doses of glimepiride, glibenclamide, and gliclazide were 2 mg/day, 1.25 mg/day, and 40 mg/day, respectively. At 8, 16, and 24 weeks, if the FPG was < 70 mg/dL or symptomatic hypoglycemic symptoms were observed by the physicians, the dose of sulfonylurea was decreased gradually as follows: for glimepiride, 2 mg, 1 mg, 0.5 mg, and withdrawal; for glibenclamide, 1.25 mg, 0.625 mg, and withdrawal; and for gliclazide, 40 mg, 20 mg, 10 mg, and withdrawal. If intolerable edema was evoked by treatment with pioglitazone, the dose of pioglitazone was decreased or withdrawn and diuretics were administered by the physicians in charge.
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
Type 2 diabetic men and women between the ages of 20-75 years whose diabetes had been inadequately controlled (HbA1c, 6.9%-9.5%) with metformin and/or sulfonylurea.
Key exclusion criteria
1) patients with a history of diabetic ketoacidosis or diabetic coma within 6 months prior to study entry
2) patients with a history of cardiac failure
3) patients who underwent a surgical operation during the observation period of this study
4) patients with severe infection or severe trauma
5) patients who were pregnant or lactating
6) patients with renal insufficiency (serum creatinine > 1.5 mg/dL, e-GFR < 30 mL/min)
7) patients with severe liver dysfunction
8) patients who had received insulin therapy
9) patients with a history of a hypersensitive reaction to sitagliptin or pioglitazone
10) patients who were judged as being inappropriate by the physicians in charge.
Target sample size
130
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
the society for diabetes of Japanese.
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 12 | 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
| 2010 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 13 | Day |
Last modified on
| 2012 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005612
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