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 UMIN000003953
Receipt No. R000004761
Scientific Title A group comparison between gliclazide and glimepiride among type 2 diabetic patients using sitagliptin.
Date of disclosure of the study information 2010/07/27
Last modified on 2013/02/17

* 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 A group comparison between gliclazide and glimepiride among type 2 diabetic patients using sitagliptin.
Acronym Sulfonylurea added on to sitagliptin; gliclazide vs. glimepiride.
Scientific Title A group comparison between gliclazide and glimepiride among type 2 diabetic patients using sitagliptin.
Scientific Title:Acronym Sulfonylurea added on to sitagliptin; gliclazide vs. glimepiride.
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 gliclazide and glimepiride as to efficacy and safety when they are added on to sitagliptin monotherapy, or used in combination therapies with sitagliptin switched from sitagliptin + metformin or sitagliptin + pioglitazone among type 2 diabetic patients with insufficient glycemic control.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ratios of subjects achieving HbA1c(JDS)<6.5% at the "primary outcome assessment point", and numbers of hypoglycemic episodes (major and minor) from the starting point to the "primary outcome assessment point".
Key secondary outcomes (A) Changes from the starting point to the "primary outcome assessment point" of the following items;
fasting plasma glucose, body weight, fasting insulin, glucagon test CPR (0 and 6 min), fasting GLP-1, fasting GIP, and power spectrum obtained with Fourier analysis of RR-intervals of ECG.
(B) Among subjects not achieving HbA1c(JDS)<6.5%, the following items 8 weeks after switching sulfonylureas;
changes of HbA1c, numbers of hypoglycemic episodes (major and minor) during the 8-weeks, fasting plasma glucose, body weight, fasting insulin, glucagon test CPR (0 and 6 min), fasting GLP-1, fasting GIP, and power spectrum obtained with Fourier analysis of RR-intervals of ECG.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gliclazide;
starting with 20 mg/day or half of equivalent dose of which sulfonylurea a subject took previously (using the preset table showing equivalence among different sulfonylureas), being stepped up to 40->60->80->120 mg/day when HbA1c(JDS) is >=6.5% and does not improve more than 0.3% every 4 weeks until it achieves <6.5% twice or it remains >=6.5% twice in spite of using 120 mg/day of gliclazide;
among subjects not achieving HbA1c(JDS)<6.5%, after assessment of the primary outcomes, gliclazide 120 mg/day is switched to glimepiride 4 mg/day and secondary outcomes (B) are assessed 8 weeks later.
Interventions/Control_2 Glimepiride;
starting with 0.5 mg/day or half of equivalent dose of which sulfonylurea a subject took previously (using the preset table showing equivalence among different sulfonylureas), being stepped up to 1->2->3->4 mg/day when HbA1c(JDS) is >=6.5% and does not improve more than 0.3% every 4 weeks until it achieves <6.5% twice or it remains >=6.5% twice in spite of using 4 mg/day of glimepiride;
among subjects not achieving HbA1c(JDS)<6.5%, after assessment of the primary outcomes, glimepiride 4 mg/day is switched to gliclazide 120 mg/day and secondary outcomes (B) are assessed 8 weeks later.
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients of type 2 diabetes satisfying the following criteria A) or B);
A) Participants of the clinical study "Switching from sulfonylurea to sitagliptin among type 2 diabetic patients in combination with metformin or pioglitazone" (UMIN000003584), not achieving HbA1c(JDS)<6.5% after 12 weeks of the sitagliptin therapy, whose written informed consent is obtainable.
B) New subjects satisfying all the following criteria;
1) receiving sitagliptin monotherapy (50 or 100 mg/day) or combination therapies of sitagliptin + metoformin (500 &#8211; 1,000 mg/day) or sitagliptin + pioglitazone (15 &#8211; 45 mg/day) for more than 12 weeks
2) with the baseline HbA1c(JDS)>=6.5% and <=9.0%, and without improvement more than 0.3% of HbA1c for 4 weeks immediately before the starting
3) having preproliferative or less advanced retinopathy, and early stage of overt proteinuria (< 1.0 g/day) or less advanced nephropathy
4) whose written informed consent is obtainable
Key exclusion criteria Patients satisfying any of the following criteria;
1) receiving or having received any combination therapies of sitagliptin + sulfonylureas
2) having more than moderate renal dysfunction (sCr > 1.5 mg/dl in men, > 1.3 mg/dl in women)
3) having severe liver dysfunction
4) having malignancy
5) being pregnant, or breast-feeding
6) having any of contraindications for gliclazide and glimepiride
7) having any of contraindications for sitagliptin
8) suspected as pheochromocytoma, or having allergic history against glucagon
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime NAKABAYASHI
Organization Kanazawa Munehiro Hospital
Division name Internal Medicine
Zip code
Address 24-30 Sakuramachi, Kanazawa 920-0923, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi NAKAGAWA
Organization Kanazawa Medical University Hospital
Division name Department of Endocrinology and Metabolism
Zip code
Address 1-1 Daigaku, Uchinada 920-0293, Japan
TEL 076-286-3511(ext.3309)
Homepage URL
Email atch-n@kanazawa-med.ac.jp

Sponsor
Institute Hokuriku Incretin-based Therapy Study Group (HINT Study Group)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 金沢医科大学病院(石川県),石川県立中央病院(石川県),富山赤十字病院(富山県),金沢宗広病院(石川県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 27 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 Terminated
Date of protocol fixation
2010 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 26 Day
Last modified on
2013 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004761

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.