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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012024
Receipt No. 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

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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
Email 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
Email hamamoto@kitano-hp.or.jp

Sponsor
Institute Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013682

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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