UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012024 |
|---|---|
| Receipt number | R000013682 |
| Scientific Title | Evaluation of long-acting insulin dose corresponding to lixisenatide dose in combination therapy of insulin and lixisenatide |
| Date of disclosure of the study information | 2013/10/11 |
| Last modified on | 2018/04/16 15:13:04 |
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Basic information
Public title
Evaluation of long-acting insulin dose corresponding to lixisenatide dose in combination therapy of insulin and lixisenatide
Acronym
Evaluation of long-acting insulin dose corresponding to lixisenatide dose
Scientific Title
Evaluation of long-acting insulin dose corresponding to lixisenatide dose in combination therapy of insulin and lixisenatide
Scientific Title:Acronym
Evaluation of long-acting insulin dose corresponding to lixisenatide dose
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the corresponding doses of long-acting insulin to two different lixisenatide doses (regular dose: 20ug/day and a half dose: 10ug/day) when the two drugs are used in combination. The changes in daily insulin dose, HbA1c, blood glucose levels, body weight, and frequency of hypoglycemia will be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in daily insulin dose of insulin glargine at 12 and 24 weeks
Key secondary outcomes
Changes in blood glucose levels (average, SD value, MAGE value), HbA1c, body weight, and frequency of hypoglycemia at 4, 8, 12 and 24 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
24Weeks
Lixisenatide 20ug once daily+Glargine/Detemir once daily
Interventions/Control_2
24Weeks
Lixisenatide 10ug once daily+Glargine/Detemir once daily
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes who are injecting basal insulin (glargine or detemir) or premixed insulin SID or BID.
2. Age >20 years old
Key exclusion criteria
1. The patients who did not agree with this study
2. The patients with serious complications
3. The patients who are at high risk for hypoglycemia
4. The patients who have the history of severe hypoglycemia (needed an emergency transport according to the hypoglycemia unawareness)
5. Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Hamamoto |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Center for Diabetes and Endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
06-6312-1221
hamamoto@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Hamamoto |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Center for Diabetes and Endocrinology
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL
06-6312-1221
Homepage URL
hamamoto@kitano-hp.or.jp
Sponsor or person
Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
Center for Diabetes and Endocrinology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute
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
| 2013 | Year | 10 | Month | 11 | Day |
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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 11 | Day |
Last modified on
| 2018 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013682
