UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004781
Receipt No. 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

* 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
Email

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
Email takebaya@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University Koshigaya Hospital Internal Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.