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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018839
Receipt No. R000021790
Scientific Title Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy
Date of disclosure of the study information 2015/09/01
Last modified on 2019/04/30

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Basic information
Public title Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy
Acronym Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy(SUMS-ADDIT-1)
Scientific Title Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy
Scientific Title:Acronym Effects of Ipragliflozin on Body Weight in Japanese Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Insulin Therapy(SUMS-ADDIT-1)
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 effects of ipragliflozin on changes in body weight from 0 to 24 weeks of Japanese patients with type 2 diabetes undergoing insulin therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in body weight from 0 to 24 weeks
Key secondary outcomes Changes and percent changes of following parameters from 0 to 24 weeks
1) Physical findings
- Systolic/diastolic blood pressure
- Pulse

2) Body composition
- Fat mass, lean body mass, and bone density measured by DEXA
- Subcutaneous fat area at the umbilical level, visceral fat area at the umbilical level, iliopsoas muscle area, and volume of the liver measured by MRI
- Intrahepatic fat mass and hepatic glycogen content measured by MRS
- Visceral fat mass and subcutaneous fat mass measured by Dual Scan
- Fat mass and muscle mass (right and left arms, right and left lower limbs, and body trunk) and water volume measured by weight scale and body composition scale

3) Glucose metabolism
HbA1c, Fasting plasma glucose, 1,5 AG, Fasting CPR, Fasting urinary glucose, Glucagon

4) Lipid metabolism
Total cholesterol, LDL cholesterol, HDL cholesterol, Blood triglyceride, Blood ketone bodies (total ketone body, ACAC, 3-OHBA), Free fatty acid in the blood, Free glycerol in the blood, RLP cholesterol

5) Liver function tests
ALT, AST, Gamma-GTP, ChE, Ferritin

6) Others
Albumin in urine, Serum uric acid, Urinary uric acid, Blood amino acid fraction, FGF-21, Cytokeratin-18, Oxidative stress marker (TBARS), Blood lipidomics, PBMC mRNA expression, Erythropoietin, Food preference

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of 50 mg ipragliflozin once daily for 24 weeks
Interventions/Control_2 Insulin therapy
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 Poorly controlled, overweight outpatients with type 2 diabetes who undergoes insulin therapy

1) Aged >= 20, <75 at consent
2) Type 2 diabetes patients undergoing insulin therapy
3) HbA1c > 7.0% and < 10.0%
4) BMI > 23 kg/m2
5) eGFR > 45 ml/min/1.73m2
6) Outpatient
7) Provided written informed consent
Key exclusion criteria 1) Has history of receiving a SGLT-2 inhibitor
2) Contraindication to the use of ipragliflozin (history of hypersensitivity to ipragliflozin, or pregnant, etc.)
3) With severe ketosis, diabetic coma, or precoma
4) Has history of hospitalization for infection, trauma, or surgery within 6 months
5) With history or under treatment of brain infarction or transient ischemic attack
6) With an episode of angina pectoris or myocardial infarction within 6 months
7) Receiving loop diuretics
8) With orthostatic hypotension
9) Considered as inadequate by the investigator
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Katsutaro
Middle name
Last name Morino
Organization Shiga University of Medical Science
Division name Department of Medicine
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL 077-548-2222
Email morino@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Akio
Middle name
Last name Tsuji
Organization Shiga University of Medical Science
Division name Clinical Reseach and Development Center
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL 077-548-3576
Homepage URL
Email hqrec@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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)

IRB Contact (For public release)
Organization Shiga University of Medical Science
Address Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
Tel 077-548-3576
Email hqrec@belle.shiga-med.ac.jp

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 滋賀医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 Day

Related information
URL releasing protocol https://onlinelibrary.wiley.com/doi/10.1111/jdi.12985
Publication of results Unpublished

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/10.1111/jdi.12985
Number of participants that the trial has enrolled 50
Results
BW change was significantly larger in the ipragliflozin group than in the control group (-2.78 vs -0.22 kg, P < 0.0001). Total fat mass was reduced evenly in the arms, lower limbs and trunk in the ipragliflozin group. Total muscle mass and bone mineral content were maintained, but muscle mass in the arms might have been affected by ipragliflozin treatment.
Results date posted
2019 Year 04 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Type 2 diabetes patients undergoing insulin therapy 
Japanese
Aged >= 20, <75 at consent 
HbA1c > 7.0% and < 10.0% 
BMI > 23 kg/m2 
eGFR > 45 ml/min/1.73m2
Participant flow
A total of 77 eligible patients with type 2 diabetes mellitus were screened at Shiga University of Medical Science Hospital. 50 were enrolled. After exclusion of one patient who withdrew consent because of breathing difficulty during MRI examination, 49 patients were randomly assigned to either the Ipra group (n = 25) or the Control group (n = 24). A total of 44 patients completed the study. One patient in the Ipra group withdrew consent before starting the intervention because of anxiety about ipragliflozin side effects. Two patients in the Ipra group discontinued the intervention, one because of exanthema and one because of liver dysfunction, but continued follow up, including bodyweight and body composition measurements. Two additional patients in the Ipra group withdrew from the intervention, one because of cholecystitis and one because of genital itching. Finally, 48 patients (Ipra, n = 24; Control, n = 24) were included in ITT analysis; however, two patients in the Ipra group were not followed up at 24 weeks and were not included in the primary analysis.
Adverse events
Hypoglycemia, dehydration, urinary tract infection, genital itching and exanthema were observed in both the Ipra and Control groups. 
Cholecystitis, gastric cancer, cataract surgery, bone fracture, and ileus were reported. All of them were incidental. The trial was continued with permission of the safety committee. 

Outcome measures
Changes in body weight from 0 to 24 weeks
Changes and percent changes of following parameters from 0 to 24 weeks 
1) Physical findings 
- Systolic/diastolic blood pressure 
- Pulse 

2) Body composition 
- Fat mass, lean body mass, and bone density measured by DEXA 
- Subcutaneous fat area at the umbilical level, visceral fat area at the umbilical level, iliopsoas muscle area, and volume of the liver measured by MRI 
- Intrahepatic fat mass and hepatic glycogen content measured by MRS 
- Visceral fat mass and subcutaneous fat mass measured by Dual Scan 
- Fat mass and muscle mass (right and left arms, right and left lower limbs, and body trunk) and water volume measured by weight scale and body composition scale 

3) Glucose metabolism 
HbA1c, Fasting plasma glucose, 1,5 AG, Fasting CPR, Fasting urinary glucose, Glucagon 

4) Lipid metabolism 
Total cholesterol, LDL cholesterol, HDL cholesterol, Blood triglyceride, Blood ketone bodies (total ketone body, ACAC, 3-OHBA), Free fatty acid in the blood, Free glycerol in the blood, RLP cholesterol 

5) Liver function tests 
ALT, AST, Gamma-GTP, ChE, Ferritin 

6) Others 
Albumin in urine, Serum uric acid, Urinary uric acid, Blood amino acid fraction, FGF-21, Cytokeratin-18, Oxidative stress marker (TBARS), Blood lipidomics, PBMC mRNA expression, Erythropoietin, Food preference
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2015 Year 07 Month 13 Day
Date of IRB
2015 Year 07 Month 28 Day
Anticipated trial start date
2015 Year 11 Month 30 Day
Last follow-up date
2017 Year 10 Month 25 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 11 Month 29 Day
Date analysis concluded
2018 Year 09 Month 18 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 28 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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