UMIN-CTR Clinical Trial

Public title

Efficacy and Safety comparison of Sitagliptin and Glimepiride in elderly Japanese patients with type 2 diabetes

Acronym

START-J: SiTAgliptin in eldeRly Trial in Japan

Scientific Title

Efficacy and Safety comparison of Sitagliptin and Glimepiride in elderly Japanese patients with type 2 diabetes

Scientific Title:Acronym

START-J: SiTAgliptin in eldeRly Trial in Japan

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the efficacy and the safety of sitagliptin and glimepiride in drug naive elderly patients with T2DM as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1.Efficacy: HbA1c change from baseline at 52 W as efficacy
2.Safety: Incidence of hypoglycaemia from randomization to 52 W

Key secondary outcomes

Comparison between two groups in the following parameters at 52W as well as 24 W as interim analysis:
1.The proportion of subjects achieving HbA1c levels <6.9% and <7.4%
2.6-point SMBG daily profile (before and 120 min after each meal)
3.Beta cell functions (fasting IRI, CPR, HOMA-B, proinsulin/insulin ratio)
4.Incidence of hypoglycaemia; as judged by Definition and evaluation of hypoglycemia
5.Body weight change from baseline
6.Time to rescue therapy with the comparator drug as combination sitagliptin+glimeripirde
7.Adverse events
8.Standard laboratory tests for safety; Hematology and biochemistry, blood pressure
9.Subanalysis according to stratum of baseline parameters: HbA1c, duration of diabetes, beta cell function

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; GFR 30=< <50).

Interventions/Control_2

Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg

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

60

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients with type 2 diabetes who are OHA naive or a-GI or BG monotherapy (to be washed out 4 weeks prior to randomization)
2.Signed informed consent obtained before any trial-related activities
3.Treatment with diet and exercise for 12 weeks and longer at screening
4.Age =>60 y.o.
5.Male and Female
6.HbA1c 6.9%=< <8.9%

Key exclusion criteria

1.Active proliferative retinopathy or maculopathy requiring treatment
2.Liver dysfunction (>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr>1.5mg/dL in male, Cr>1.3mg/dL in female, GFR<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
3.Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
4.Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
5.Previous history of severe allergy to pharmaceutical products
6.Systemic glucocorticoids users or potential users
7.Suspected type 1 diabetes (including SPIDDM) or positive anti-GAD antibody
8.Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis

Target sample size

900

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Terauchi

Organization

Yokohama City University School of Medicine

Division name

Department of Endcrinology & Metabolism

Zip code

Address

3-9 Fukuura, Kanazawa-Ku, Yokohama City 236-0004

TEL

Email

Name of contact person

1st name
Middle name
Last name	Nobuyuki Shihara

Organization

Japan Association for Diabetes Education and Care

Division name

secretariat

Zip code

Address

2-2-4 Koujimachi, Chiyoda-ku, Tokyo 102-0083

TEL

03-3514-1721

Homepage URL

http://www.nittokyo.or.jp/

Email

shihara@nittokyo.or.jp

Institute

Japan Association for Diabetes Education and Care

Institute

Department

Personal name

Organization

Banyu pharmaceutical Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT01183104

Org. issuing International ID_1

Clinicaltrial.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

08

Month

16

Day

URL releasing protocol

http://edmsweb11.eps.co.jp/start-j/

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

Completed

Date of protocol fixation

2010

Year

06

Month

07

Day

Date of IRB

Anticipated trial start date

2010

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

08

Month

16

Day

Last modified on

2015

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004851