UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012697 |
|---|---|
| Receipt number | R000014835 |
| Scientific Title | Patient satisfaction, efficacy and safety of combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2016/06/26 00:15:42 |
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Basic information
Public title
Patient satisfaction, efficacy and safety of combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes
Acronym
Patient satisfaction of combination therapy with lixisenatide and basal insulin
Scientific Title
Patient satisfaction, efficacy and safety of combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes
Scientific Title:Acronym
Patient satisfaction of combination therapy with lixisenatide and basal insulin
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the patient satisfaction level of combination therapy with lixisenatide and basal insulin with that of multiple insulin injection therapy in patients with uncontrolled type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diabetes Treatment Satisfaction Questionnaire(DTSQ) at 0 and 12 weeks after switching from multiple insulin injection therapy to combination therapy with lixisenatide and basal insulin
Key secondary outcomes
The daily profile of blood glucose, changes of HbA1c and body weight at 0 and 12 weeks after switching from multiple insulin injection therapy to combination therapy with lixisenatide and basal insulin
Incidence of hypoglycemia
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lixisenatide group:
In type 2 diabetic patients treated with multiple insulin injection therapy, discontinue rapid-acting insulin and add on lixisenatide at 20ug.
Continue basal insulin.
Interventions/Control_2
Multiple insulin group:
Continue multiple insulin injection therapy
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 whose HbA1c were >=6.0%, <9.0%, type 2 diabetic patients
2) Patients treated with multiple insulin injection therapy for more than 3 months
3) Patients whose total dose of daily insulin were <=30 units.
Key exclusion criteria
1) Patients who have history of diabetic ketoacidosis, or diabetic coma in the past 6 months
2) Patients who are pregnant or in lactation period
3) Patients with serious infectious disease, before operation, serious trauma
4) Patients who receive steroid therapy
5) Patients with severe liver dysfunction
6) Patients with type 1 diabetes
7) Patients with disorder of insulin secretion whose fasting serum C-peptide <0.5ng/ml
8) Patients with hypersensitivity to these medicines
9) Patients who have history of pancreas disease
10) Patients who have history of cancer
11) Patients receiving with GLP-1 receptor agonist or he DPP-4 inhibitor in the past 3 months
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
North 15,West 7,Kita-ku,Sapporo,Hokkaido,060-8638
TEL
011-706-5915
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinobu Nakamura |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
North 15,West 7,Kita-ku,Sapporo,Hokkaido,060-8638
TEL
011-706-5915
Homepage URL
akinbo@tim.hi-ho.ne.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
北海道大学病院（北海道）
NTT東日本札幌病院（北海道）
帯広厚生病院（北海道）
釧路赤十字病院（北海道）
苫小牧市立病院（北海道）
沖医院（北海道）
栗原内科（北海道）
青木内科クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 25 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 25 | Day |
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
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2016 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014835
