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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004396 |
Receipt No. | R000005218 |
Scientific Title | A randomized, multi-center trial to compare the efficacy of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese type 2 diabetes patients with oral hypoglycaemic agents therapy. |
Date of disclosure of the study information | 2010/10/16 |
Last modified on | 2014/04/16 |
Basic information | ||
Public title | A randomized, multi-center trial to compare the efficacy of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese type 2 diabetes patients with oral hypoglycaemic agents therapy. | |
Acronym | Once-J Study | |
Scientific Title | A randomized, multi-center trial to compare the efficacy of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese type 2 diabetes patients with oral hypoglycaemic agents therapy. | |
Scientific Title:Acronym | Once-J Study | |
Region |
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Condition | ||
Condition | Type 2 DM | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Comparison the efficacy and the safety using continuous glucose monitoring (CGM) of once-daily insulin detemir and biphasic insulin aspart-30 in Japanese patients with type 2 diabetes mellitus on monotherapy or combination therapy with sulfonylureas, biguanides and thiazolidinediones. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 24 hour glycemic variations using CGM
Change of HbA1c value Frequency of hypoglycemia during an observation period |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Once-daily insulin detemir | |
Interventions/Control_2 | Once-daily biphasic insulin aspart-30 | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Consent of the participation to this study by a document.
More than three months since subjects were diagnosed as Type 2 diabetes mellitus. Not having insulin treatment within six months. HbA1c>8.0%,<10% BMI<30kg/m2 Monotherapy or combination therapy with oral hypoglycaemic agents (Sulfonylureas,Thiazolidinediones,Biguanides). |
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Key exclusion criteria | Hypoglycemia
Insulin allergy having participated in this study in the past amount of medicine for usage out of an authorized use Severe retinopathy Pregnancy Nursing Past using Alpha-GIs or Glinides within two months In addition, Medical attendants judged not to be appropriate as a subject of this study |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The Jikei University School of Medicine | ||||||
Division name | Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, Japan | ||||||
TEL | 03-3433-1111(3243) | ||||||
rimei@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | The Jikei University School of Medicine | ||||||
Division name | Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine | ||||||
Zip code | |||||||
Address | 3-25-8 Nishishinbashi, Minato-ku, Tokyo, 105-8461, Japan | ||||||
TEL | 03-3433-1111(3243) | ||||||
Homepage URL | |||||||
dtsujino7777@gmail.com |
Sponsor | |
Institute | The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine |
Institute | |
Department |
Funding Source | |
Organization | The Jikei University School of Medicine, Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005218 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |