UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016390
Receipt No. R000019035
Scientific Title Efficacy and safety of switching from TWIce-daily exenatide to oNce-weekly exenatide in Japanese patients with type 2 diabetes mellitus;Multicenter, Prospective, Single-arm trial
Date of disclosure of the study information 2015/02/01
Last modified on 2019/04/10

* 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 Efficacy and safety of switching from TWIce-daily exenatide to oNce-weekly exenatide in Japanese patients with type 2 diabetes mellitus;Multicenter, Prospective, Single-arm trial
Acronym Twin-exenatide Study
Scientific Title Efficacy and safety of switching from TWIce-daily exenatide to oNce-weekly exenatide in Japanese patients with type 2 diabetes mellitus;Multicenter, Prospective, Single-arm trial
Scientific Title:Acronym Twin-exenatide Study
Region
Japan

Condition
Condition Adult patients with type 2 diabetes mellitus (over 20 years of age)
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and the safety of exenatide once weekly (QW) versus twice daily (BID) in Japanese patients with type 2 diabetes mellitus treated with monotherapy or combined use with sulphonylurea, biguanide and/or thiazolidinedione.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in HbA1c level at week 24
Key secondary outcomes Change in the following measurements at week 24
・Glucose, GA, and 1,5-AG
・Percentage of patients achieving less than 7 % of HbA1c
・7-point Self Monitoring of Blood Glucose (SMBG)
・Height, body weight
・Waist Circumference
・Blood pressure, pulse
・Beta-cell function, insulin resistance
Insulin
C-peptide
HOMA-Beta, HOMA-IR
Proinsulin/Insulin Ratio
Glucagon
・Biochemical markers:
Aspartate aminotransferase (AST)
Alanine aminotransferase (ALT)
Serum creatinine
Uric acid
Total cholesterol
HDL-cholesterol
Triglyceride (TG)
Free Fatty Acid (FFA)
Amylase, Lipase
・Oxidative stress, inflammatory markers
High-sensitivity CRP (hsCRP)
Adiponectin
8-hydroxy-2'-deoxyguanosine (8-OHdG)
8-iso-prosraglandin F2alfa(8-isoPFG2alfa)
・The Japanese Version of Questionnaire about gastrointestinal symptom
・The Japanese Version of the Diabetes Treatment Satisfaction Questionnaire (DTSQs)
・Diabetes-Medication Satisfaction Tool (DM-SAT)
・Questionnaire for hypoglycaemia
・Adverse events
Event name
Expression day
Seriousness
Severity
Outcome
Outcome confirmation day
Causation
・Optional measurements: Change in the following measurements at week 24.
Blood glucose levels and glycemic variability obtained by continuous glucose monitoring (CGM)
Incidence of hypoglycaemic episodes detected by CGM
Endothelial function by flow-mediated dilatation (FMD)
Visceral fat measured by computed tomography (CT) imaging
Gastrointestinal motility function (13C breath test)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In patients who are dosed with exenatide at 10 to 20 microgram/day 2 times/day (BID) for 12 weeks or longer, this dose method is to be switched to 2 mg/time once a week (QW), followed by continuous administration for further 24 weeks.
Interventions/Control_2
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) Adult patients with type 2 diabetes mellitus (over 20 years of age)
(2) Patients treated with Byetta (over 12 weeks) (combined use of sulphonylurea, biguanide and/or thiazolidinedione is permissible)
(3) Patients from whom written informed consent for participation is obtained.
Key exclusion criteria (1) Patients with type 1 diabetes mellitus,
(2) Patients with diabetic ketoacidosis
(3) Patients with diabetic coma and pre-coma
(4) Patients with history of serious hypersensitivity to exenatide or any of its components
(5) Patients who are pregnant or who intend to become pregnant
(6) Patients with severe infections
(7) Patients at emergency surgery
(8) Patients with severe renal dysfunction, and patients on dialysis
(9) Any other condition which the attending physician feels would interfere with trial participation
Target sample size 59

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Saisho
Organization Keio University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo, 1608582 Japan
TEL 03-3353-1211
Email ysaisho@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohide Noumi
Organization IBEC Co., Ltd.
Division name CEO office
Zip code
Address Tanaka Jun Buld. 3F, 2-5-14 Teradacho, Tennohji-ku, Osaka-shi, 5430045, Japan
TEL 06-7172-1751
Homepage URL
Email ibc102@ibec-jp.com

Sponsor
Institute Nonprofit Organization Hokkaido Health-Science Institute
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor ・Keio University School of Medicine Department of Internal Medicine
・IBEC Co., Ltd.
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 慶應義塾大学医学部腎臓内分泌代謝内科(東京)
東京歯科大学市川総合病院 (千葉県)
横浜市立市民病院(神奈川県)
川崎市立井田病院(神奈川県)
公益財団法人ライフ・エクステンション研究所付属永寿総合病院(東京)
医療法人社団梨慶会するがクリニック(静岡)
平塚市民病院(神奈川)
医療法人社団宏徳会徳井内科クリニック(神奈川)
財団法人日本相撲協会診療所(東京)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 01 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 62
Results
The study is not registered to UMIN because the specific clinical research studies are registered and released to jRCT due to the Clinical Research Law enforcement.
Results date posted
2019 Year 04 Month 10 Day
Results Delayed
Delay expected
Results Delay Reason Since the study period is until December 31, 2019, we are now preparing the paper.

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
2014 Year 10 Month 15 Day
Date of IRB
2014 Year 12 Month 12 Day
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
2017 Year 05 Month 12 Day
Date of closure to data entry
2017 Year 07 Month 26 Day
Date trial data considered complete
2017 Year 08 Month 15 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 30 Day
Last modified on
2019 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019035

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.