UMIN-CTR Clinical Trial

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

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Hokuriku Incretin-based Therapy Study Group (HINT Study Group)

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2010

Year

07

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

07

Month

26

Day

Last modified on

2013

Year

02

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004761