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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011420
Receipt No. R000013214
Scientific Title Add-on or switch to repaglinide for type 2 diabetes with sitagliptin: Randomized controlled open-labelled trial.
Date of disclosure of the study information 2013/08/08
Last modified on 2017/02/18

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Basic information
Public title Add-on or switch to repaglinide for type 2 diabetes with sitagliptin: Randomized controlled open-labelled trial.
Acronym Add-on or switch to repaglinide for type 2 diabetes with sitagliptin.
Scientific Title Add-on or switch to repaglinide for type 2 diabetes with sitagliptin: Randomized controlled open-labelled trial.
Scientific Title:Acronym Add-on or switch to repaglinide for type 2 diabetes with sitagliptin.
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy and safety of combination therapy with sitagliptin and repaglinide in comparison with repaglinide monotherapy in type 2 diabetes whose sitagliptin monotherapy is insufficiet.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of changes of HbA1c and meal loading test after 24 weeks treatment of combination therapy and monotherapy of repaglinide.
Key secondary outcomes Effects on glucagon and insulin secretion evaluated by meal loading test.

Comparison of frequency of hypoglycemic
episodes during 24 weeks treatment of
combination therapy and monotherapy of
repaglinide.

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 combination therapy with sitagliptin and
repaglinide
Interventions/Control_2 monotherapy with repaglinide
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 Type 2 diabetic patients whose HbA1c level is more than 6.9 % and less than 8.4% even after diet, exercise, and administration of sitagliptin 50 mg/day.
1) HbA1c level is more than 6.9 % and less than 8.4 % for 3 months.
2) The changes in HbA1c level is plus/minus 0.5 % for 3 months.
3) Continue diet and exercise therapy for more than 6 months.
4) Taking sitagliptin for more than 3 months.
5) Biguanide or thiazolidinedione user can be included but not to change dosage and not to add-on these drugs during trial period.
6) Those who can understand the instruction and agree on the written consent.
Key exclusion criteria 1) Type 1 diabetes.
2) Patients who has been prescribed sulfonylurea or alpha glucosidase inhibitor.
3) Patients who have serious liver disease
(AST and/or ALT are more than 100 IU/L).
4) Patients who have serious kidney disease(Serum Cr level is more than 2.0 mg/dL).
5) Patients who have serious heart disease (patients who have apparent heart failure or myocardial infarction within 3 months).
6) Patients who have serious pancreatic
disease.
7) Patients with cancer.
8) Anemic patients (Hb level is less than 11g/dL).
9) Patients with thrombocytepenia (Platelet count is less than 100000/mm3)
10) Patients with serious diabetic complications including progressed
neuropathy and proliferative retinopathy.
11) Patietns with serious infection,
inflammation, or injury, preoperative or postoperative state.
12) Patients who have inflammatory bowel
disease, ulcer in bowel, ileus and high risk for ileus.
13) Patinets with chronic bowel diseases
which have probability to induce malabsorption syndrome.
14) Patients who have the disease which is
deteriorated with increase of gas in bowel
15) Heavy alcohol drinker (patients who drink more than 480mL of Japanese Sake, 2L of beer, 180mL of whisky, 360mL of wine, or 360mL of Shochu per day).
16) Patients who are pregnant, hope to be
pregnant, or are in lactation period.
17) Patients who have viral infection
(HBV,HCV).
18) Patients who are not applicable to this study judged by the medical doctor.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Hirose MD PhD
Organization Toho University Graduate School of Medicine.
Division name Department of Diabetes, Metabolism, and Endocrinology
Zip code
Address 6-11-1 Omori-Nishi Ota-ku, Tokyo, 143-8541, Japan
TEL 03-3762-4151
Email takahisa.hirose@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Hirose MD PhD
Organization Toho University Graduate School of Medicine.
Division name Department of Diabetes, Metabolism, and Endocrinology
Zip code
Address 6-11-1 Omori-Nishi Ota-ku, Tokyo, 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email takahisa.hirose@med.toho-u.ac.jp

Sponsor
Institute Toho University Graduate School of Medicine.
Institute
Department

Funding Source
Organization Toho University Graduate School of Medicine.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Toranomon Hospital
Name of secondary funder(s) none

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 東邦大学医療センター大森病院(東京都)、虎の門病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 08 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 05 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 08 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 08 Month 08 Day
Last modified on
2017 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013214

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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