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Recruitment status Completed
Unique ID issued by UMIN UMIN000014790
Receipt No. R000017196
Official scientific title of the study Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors
Date of disclosure of the study information 2014/08/07
Last modified on 2016/10/18

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Basic information
Official scientific title of the study Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors
Title of the study (Brief title) Investigation of the efficacy and safety of ipragliflozin combination therapy in case of insufficient glycemic control by DPP-4 inhibitors
Region
Japan

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

Objectives
Narrative objectives1 To investigate the influences of hypoglycemic effect and body weight in patients with poorly controlled type 2 diabetes whereas undergoing DPP-4 inhibitor treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in HbA1c from baseline to 24 weeks
Key secondary outcomes Change in following items from baseline to 12 and 24 weeks

1) HbA1c (Except for 24 week), GA
2) Body weight
3) Fasting plasma glucose
4) Serum insulin (HOMA-beta, HOMA-R) and serum C-peptide
5) Waist circumference (Except for 12 week)
6) Blood pressure and heart rate
7) Uric acid
8) Serum cystatin C (Except for 12 week)
9) Serum lipids (TC, LDL-C, HDL-C, and TG)
10) RLP-C (Remnant like particles cholesterol) (Except for 12 week)
11) ApoB, ApoA-1, ApoB/ApoA-1 ratio (Except for 12 week)
12) Thioredoxin-interacting protein (TXNIP) (Except for 12 week)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 24 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged 20 to 80 years at providing consent
2) Poorly glycemic controlled patients nevertheless who undergoes DPP-4 inhibitors at least 12 weeks
3) HbA1c >= 6.5 and < 9.5%
4) BMI >= 22 kg/m2
5) Received informed consent
Key exclusion criteria 1) Type 1 diabetes
2) With severe ketosis, diabetic coma, or precoma
3) With severe infection, pre or post surgery, and serious trauma
4) With severe hepatic dysfunction (Over grade 3 in classification criteria for severity of adverse drug reactions)
5) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL)
6) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months
7) Is receiving SGLT-2 inhibitors, GLP-1 antagonists, or insulin therapy at consent
8) Is nursing or pregnant or planned to become pregnant
9) With hypersensitivity to ipragliflozin or any other excipient of ipragliflozin
10) Considered as inadequate by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator Kenji Furukawa
Organization Japan Community Health care Organization Kanazawa Hospital
Division name internal
Address Ha-15, Oki-machi, Kanazawa-city, Ishikawa, Japan
TEL 076-252-2200
Email kenjif-knz@umin.ac.jp

Public contact
Name of contact person Kenji Furukawa
Organization Japan Community Health care Organization Kanazawa Hospital
Division name internal
Address Ha-15, Oki-machi, Kanazawa-city, Ishikawa, Japan
TEL 076-252-2200
Homepage URL
Email kenjif-knz@umin.ac.jp

Sponsor
Institute Japan Community Health care Organization Kanazawa Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2014 Year 08 Month 07 Day

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 10 Day
Anticipated trial start date
2014 Year 08 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 08 Month 07 Day
Last modified on
2016 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017196


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