UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004781 |
|---|---|
| Receipt number | R000005690 |
| Scientific Title | Investigation of suitable administration-time of GLP-1 receptor agonist on glycemic control in patients with type 2 diabetes: multicenter-randomized non-blind study |
| Date of disclosure of the study information | 2010/12/25 |
| Last modified on | 2017/06/30 16:38:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of suitable administration-time of GLP-1 receptor agonist on glycemic control in patients with type 2 diabetes: multicenter-randomized non-blind study
Acronym
Study of suitable administration-time of liraglutide (morning vs. evening): Time study
Scientific Title
Investigation of suitable administration-time of GLP-1 receptor agonist on glycemic control in patients with type 2 diabetes: multicenter-randomized non-blind study
Scientific Title:Acronym
Study of suitable administration-time of liraglutide (morning vs. evening): Time study
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to investigate the suitable adiministratin-time (morning versus evening) of liraglutide using hemoglobin A1c in 14 week and 52 week after initiation of liraglutide-therapy as an index of glycemic control in patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
HbA1c values of patients on baseline and at 14, 52 week after initiation of liraglutide-therapy
Key secondary outcomes
1)Fasting or postprandial plasma glucose, serum lipids, serum C-peptide, IRI,body weight, and blood pressure of patients on baseline and at 14, 38, 52 week after initiation of liraglutide-therapy
2)Change of HbA1c values, plasma glucose levels, serum C-peptide, IRI,serum lipids, body weight, blood pressure of patients on baseline and at 14, 26, 38, 52 week after initiation of liraglutide-therapy
3) Evaluation of side-effects: nausea, vomiting, diarrhea, constipation, hypoglycemic symptom, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Enrollment and assignment of patients in 4 weeks before initiation of liraglutide-therapy. Doses of liraglutide are 0.3 mg/day during first 1 week, 0.6 mg/day during next 1 week, and subsequently 0.9 mg/day.
All anti-diabetic drugs must be discontinued except sulfonylureas (SU). Doses of SUs should be respectively decreased to glibenclamide 1.25 mg/day, glimepiride 0.5-2mg/day, gliclazide 40 mg/day. Patents will be assigned into 2 groups (morning-adominitration group or evening administration group).Observation of 14 weeks after initiation of liraglutide therapy is needed.
Interventions/Control_2
Doses of SUs should be increased to glibenclamide 2.5 mg/day, glimepiride 3 mg/day, gliclazide 80 mg/day if patients'HbA1c exceeds 8% at 14 weeks. Further 12 weeks-observation is needed.
Change liraglutide to insulin (insulin detemir once a day) if patients'HbA1c still exceeds 8% at 26 weeks. Doses of insulin should be adjusted based on each patient's fasting plasma glucose.Change liraglutide from daily administration (once a day) to alternative administration (once a day) if patient's HbA1c are less than 7% at 26 weeks. Further 12 weeks-observation is needed.
Change insulin detemir (once a day)- therapy to insulin basal-bolus therapy (insulin detemir once a day with 3 times insulin aspart before each meal) or to multiple-administration of mix-insulin if patients'HbA1c still exceeds 8% at 38 weeks. Further 14 weeks-observation (to 52 weeks) is needed.
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 age >20 years
2)Patients who are diagnosed as type 2 diabetes
3)Patients treated with diet and exercise alone, or ones with oral anti-diabetic drugs in addition to diet-and exercise-therapy
4)HbA1c of patients>=6.1%JDS (>=6.5%NGSP)
5)Patients who gave a written informed consent for participation for this study
Key exclusion criteria
1)Patients with hypersensitivity for liraglutide
2)Patients who developed diabetic ketoacidosis, diabetic coma
3)Patients with type 1 diabetes
4)Patients with severe infection, liver dysfunction[AST>=80IU/L, ALT>=80IU/L], and renal dysfunction [serum creatinine>=1.7mg/mL]
5)Patients under artificial dialysis
6)Patients with severe heart disease (NYHA3-4)
7)Patients with oral anti-diabetic drugs except for SUs, or insulin at initiation of liraglutide therapy
8)Patients with past history of pancreatitis
9)Patients with diabetic gastroparesis or gastrointestinal disease such as inflammatory bowel disease
10)Patients in pregnancy, during lactation, or having possibility of pregnancy
11)Patients with pasthistory of medullary thyroid cancer,Patients with family history of medullary thyroid cancer,and multiple endocrine neoplasia type 2
12)Patients who was comsident to be inadequate for enrollment in this study by doctors
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohzo Takebayashi |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Internal Medicine
Zip code
Address
2-1-50, Minamikoshigaya, Koshigaya, Saitama, Japan
TEL
048-965-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohzo Takebayashi |
Organization
Dokkyo Medical University Koshigaya Hospital
Division name
Internal Medicine
Zip code
Address
2-1-50, Minamikoshigaya, Koshigaya, Saitama, Japan
TEL
+81-48-965-1111
Homepage URL
takebaya@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Koshigaya Hospital Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | 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
| 2010 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 22 | Day |
Last modified on
| 2017 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005690
