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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004716
Receipt No. 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

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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
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 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005612

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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