UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003537 |
|---|---|
| Receipt number | R000004296 |
| Scientific Title | Comparative study of the usefulness of a novel insulin therapy in Japanese patients with Type 2 diabetes for concomitant use of an oral antidiabetic agent with twice-daily dosing either of insulin aspart, biphasic insulin aspart-30, or insulin detemir. |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2020/07/24 08:34:41 |
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Basic information
Public title
Comparative study of the usefulness of a novel insulin therapy in Japanese patients with Type 2 diabetes for concomitant use of an oral antidiabetic agent with twice-daily dosing either of insulin aspart, biphasic insulin aspart-30, or insulin detemir.
Acronym
Two times Insulin injection Combined with oral therapy Efficacy Study (TWICE study)
Scientific Title
Comparative study of the usefulness of a novel insulin therapy in Japanese patients with Type 2 diabetes for concomitant use of an oral antidiabetic agent with twice-daily dosing either of insulin aspart, biphasic insulin aspart-30, or insulin detemir.
Scientific Title:Acronym
Two times Insulin injection Combined with oral therapy Efficacy Study (TWICE study)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Usefulness of introducing a novel insulin therapy will be comparatively studied in Japanese patients with Type 2 diabetes under treatment with an oral antidiabetic agent for concomitant use of an oral antidiabetic agent with twice-daily dosing either of insulin aspart, biphasic insulin aspart-30, or insulin detemir.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement rate of HbA1c < 7.0%
Key secondary outcomes
Safety (frequency of adverse events/hypoglycemia, etc.)
Dose
Changes in casual blood sugar level
Changes in and mean values of blood glucose level before breakfast, blood glucose level 2 hours after breakfast, blood glucose level before dinner, and blood glucose level after dinner
Comprehensive efficacy evaluation by the doctor
Changes in body weight
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
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Twice a day (before breakfast and dinner) insulin aspart+SU agent
Interventions/Control_2
Twice a day (before breakfast and dinner) biphasic insulin aspart-30
Interventions/Control_3
Twice a day (before breakfast and dinner) insulin detemir + glinide derivative insulin releasing agent (before breakfast and dinner)
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who meet the following conditions
(1)Patients younger than 75 years old
(2)Patients with 7.5%<HbA1c<10.0% immediately before study entry
(3)Patients administered an oral antidiabetic agent for three months or more (except for DPP4 inhibitory drugs)
(4)Patients with ability to consent from whom written consent can be obtained
(5)Patients with recent HbA1c 10.0%< but judged as eligible by their doctor in charge
Key exclusion criteria
A patient who falls under any of the following conditions shall be excluded:
(1)Already under insulin treatment on outpatient basis
(2)A patient with BMI higher than 35
(3)A patient with severe proteinuria
(4)A patient with decompensated liver cirrhosis or renal failure
(5)A patient with unstable proliferative diabetic retinopathy
(6)A patient with severe neurologic disorder
(7)A patient administered steroid drugs
(8)A patient who is pregnant or is likely to become pregnant in the near future
(9) A patient engaged in night shift work or keeping irregular hours
(10) Other patients determined to be inappropriate by the doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsuyasu |
| Middle name | |
| Last name | Itoh |
Organization
Fujita Health University Hospital
Division name
Department of Internal Medicine, Division of Endocrinology & Metabolism
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-9242
mituyasu@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuyasu |
| Middle name | |
| Last name | Itoh |
Organization
Fujita Health University Hospital
Division name
Department of Internal Medicine, Division of Endocrinology & Metabolism
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-9242
Homepage URL
endolabo@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Endocrinology & Metabolism, Fujita Health University, School of 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
the ethics review committee of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
Tel
0562932211
hp1gyomu@fujita-hu.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
・豊田厚生病院（愛知県）（Division of Endocrinology & Metabolism, Toyota Kosei Hospital (Aichi Prefecture)）
・豊川市民病院（愛知県）（Diabetes and Endocrine Division, Toyokawa City Hospital (Aichi Prefecture)）
・藤田保健衛生大学坂文種報徳會病院（愛知県）（Endocrinology & Metabolism, Banbuntane Hotokukai Hospital (Aichi Prefecture)）
・刈谷豊田総合病院（愛知県）（Endocrinology and Metabolism, Kariya Toyota General Hospital (Aichi Prefecture)）
・安城更生病院（愛知県）（Diabetes and Endocrine Division, Anjo Kosei Hospital (Aichi Prefecture)）
・トヨタ記念病院（愛知県）（Endocrinology, Toyota Memorial Hospital (Aichi Prefecture)）
・岡崎市民病院（愛知県）（Endocrinology, Okazaki City Hospital (Aichi Prefecture)）
・高橋ファミリークリニック（愛知県）（Takahashi Family Clinic (Aichi Prefecture)）
・川部内科皮膚科（愛知県）（Endocrinology, Okazaki City Hospital (Aichi Prefecture)）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.20407/fmj.2019-023
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.20407/fmj.2019-023
Number of participants that the trial has enrolled
31
Results
Twelve, eight, and eight patients were treated with Aspart, Mix, or Determir, respectively, for 52 weeks. After 12 weeks, the reductions in HbA1c were similar in the groups. After 52 weeks, the target of an HbA1c <7.4% was achieved in 16.7% of the Aspart group, 37.5% of the Mix group, and 12.5% of the Detemir group, and no significant differences among the three groups. The mean changes from baseline in blood glucose concentration were also similar in each group.
Results date posted
| 2020 | Year | 05 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with T2DM were eligible to participate if they had a baseline HbA1c of 7.8-10.4%, and they were 20-75 years old at the screening visit.
Participant flow
Thirteen patients were treated with Aspart plus an SU (Aspar group:The mean baseline HbA1c was 9.86%), nine were treated with Mix (Mix group:9.24%), and nine were treated with Detemir plus a glinide (Detemir group:11.26%), and for the
efficacy of twice daily insulin injection combined with oral diabetic therapy. Twelve patients treated with Aspart, nine
patients treated with Mix, and eight patients treated with Detemir completed the full 52 weeks of the study. One patient treated with Mix achieved good glycemic control and discontinued his insulin after 15 weeks.
Adverse events
There were no severe cases of hypoglycemia . There were no adverse effects detected using liver enzyme assays, serum electrolyte measurement, or hematology in the three groups throughout the study period One participant in the Mix group was reported to have developed heart failure, but the physician in charge decided that this was related to the patient' pre-existing coronary heart disease, rather than the study protocol, and therefore they continued their participation to the end of study.
Outcome measures
Twice-daily injections of a premix are equally or more effective
against hyperglycemia and similarly safe compared with twicedaily
injections of aspart plus an SU and detemir plus a glinide in
patients being treated with AHAs. Early and clinically meaningful
reductions in HbA1c were achieved using twice-daily injections
of premix, aspart plus an SU, or detemir plus a glinide, without
severe hypoglycemia or an increase in body mass.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2020 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004296
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