![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004356 |
Receipt No. | R000004828 |
Scientific Title | Comparison of thrice daily insulin aspart and thrice daily insulin aspart 70/30 on glycemic control and safety in type 2 diabetes |
Date of disclosure of the study information | 2010/10/31 |
Last modified on | 2012/06/02 |
Basic information | ||
Public title | Comparison of thrice daily insulin aspart and thrice daily insulin aspart 70/30 on glycemic control and safety in type 2 diabetes | |
Acronym | effect of thrice daily aspart 70/30 on
type 2 diabetes |
|
Scientific Title | Comparison of thrice daily insulin aspart and thrice daily insulin aspart 70/30 on glycemic control and safety in type 2 diabetes | |
Scientific Title:Acronym | effect of thrice daily aspart 70/30 on
type 2 diabetes |
|
Region |
|
Condition | ||
Condition | type 2 diabetes | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the effects of thrice daily Aspert and thrice daily Aspert 70/30 on
glycemic control and safety |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | comparison of glycemic control(HbA1c, BSDP monitored by SMBG, and safety (frequency of hypoglycemia)
|
Key secondary outcomes | influence on atheregenic infectious marker and total dose of daily insulin |
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 |
|
|
Interventions/Control_1 | thrice daily biphasic insulin aspart 70/30 | |
Interventions/Control_2 | thrice daily ultra-rapid insulin aspart | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1)Type 2 diabetes patients whose glycated hemoglobin level are between 6.5 and 8.0 %
2)glycated hemoglobin level were stable during last three months (-0.5 to 0.5%) 3)subjects who are already performing diet and exercise therapy for 6 months 4)subjects who were prescribed only ultra rapid insulin thrice daily for more than 6 months 5)no ristriction on the drugs already prescribed but no allowance to stop them or change the doses of them. It is possible to change those to avoid adverse effects like hypoglycemia 6)subjcets whose age are more than 20 years. 7)no restriction on gender 8)subjects who chan understand informed consent |
|||
Key exclusion criteria | 1) type 1 diabetes
2) patients who have serious liver disease (AST and/or ALT are more than 100IU/L) 3) patients who have serious kidney disease (Serum Cr is more than 2.0mg/dL) 4) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months) 5) patients who have serious pancreatic disease 6) patients with cancer 7) anemic patients (Hb is less than 11g/dL) 8) patients with thrombocytepenia (Platelet count is less than 100000/mm3) 9) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy 10) patietns with serious infection, inflammation, or injuary. pre- or post- operative state 11) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus 12) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome 13) patients who has the disease which is deteriorated with increase of gas in bowel 14) heavy alcohol drinker (patients who drink more than 480mL of Japanese Sake, 2L of beer, 180mL of whisky, 360mL of wine, or 360mL of Shochu per day) 15) patients who are pregnant, hope to be pregnant, or are in lactation period 16) patients who have viral infection (HBV,HCV) 17) patients who are not applicable to this study judged by the medical doctor. |
|||
Target sample size | 70 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Juntendo University Graduate School of Medicine | ||||||
Division name | Dept of Medicine, Metabolism and Endocrinology | ||||||
Zip code | |||||||
Address | 2-1-1 Hongo Bunkyo-ku Tokyo Japan | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Juntendo University Graduate School of Medicine | ||||||
Division name | Dept of Medicine, Metabolism and Endocrinology | ||||||
Zip code | |||||||
Address | |||||||
TEL | |||||||
Homepage URL | |||||||
hirosemd@juntendo.ac.jp |
Sponsor | |
Institute | Dept of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | none |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004828 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |