UMIN-CTR Clinical Trial

Public title

The effect of sitagliptin on circadian rhythm in blood glucose using CGM (continuous glucose monitoring) in the elderly patients with diabetes

Acronym

The effect of sitagliptin on circadian rhythm in blood glucose using CGM (continuous glucose monitoring) in the elderly patients with diabetes

Scientific Title

The effect of sitagliptin on circadian rhythm in blood glucose using CGM (continuous glucose monitoring) in the elderly patients with diabetes

Scientific Title:Acronym

The effect of sitagliptin on circadian rhythm in blood glucose using CGM (continuous glucose monitoring) in the elderly patients with diabetes

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effect of sitagliptin (monotherapy or addiational dosage) on circadian rhythm in blood glucose using CGM (continuous glucose monitoring) in the elderly patients with poorly-controlled diabetes, and to assess safety and efficacy of sitagliptin in the elderly

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

circadian rhythm in blood glucose using CGM
change in HbA1c

Key secondary outcomes

The change in
1) fasting glood glusoce
2) BMI
3) blood pressure
4) urinary sodium concentration
5) serum creatinine
6) plasma glucagon concetration
7) comprehensive geriatric assessment; IADL, Barthel index, MMSE and GDS

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

25mg or 50mg of sitagliptin

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

Age-lower limit

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) The patients with type 2 diabetes, 70 years of age and older
2) The subjects with poorly-controlled diabetes by:
1. diet and exercise only
2. sulfonylureas with diet and exercise
3. thiazolidinediones with diet and exercise
4. biguanides with diet and exercise
5. alpha-glucosidase inhibitors with diet and exercise
6. insulin therapy with diet and exercise
3) more than 8g/day of estimated sodium intake calculated by the following formula: 0.0585X21.98X((urinary sodium concentration/urinary potassium concentration)X(-2.04Xage+
14.89XBW(kg)+16.14XBH(cm)-2244.45))0.392)

Key exclusion criteria

1) the patients wiht type 1 diabetes
2) the subjects with severe renal dysfunction: more than 2.5mg/dl of serum creatinine in male, more than 2.0mg/dl of serum creatinine in female
3) the subjects who cannot reduce the dosage of sulfonylureas (using more than 2mg/day of glimepiride, 1.25mg/day of glibenclamide, 40mg of gliclazide
4) the subjects during pregnancy or lactation
5) the subjects in active treatment for hypothyroidism
6) the subjects with severe liver dysfunction: more than 100IU/L of AST and ALT level
7) the subjects already enrolled in other clinical trial
8) the subjects found offensive by attending physicians for this research

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Ken Sugimoto

Organization

Osaka University Graduate School of Medicine

Division name

Geriatric Medicine

Zip code

Address

2-2, Yamada-oka, Suita, Osaka

TEL

06-6879-3852

Email

sugimoto@geriat.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Ken Sugimoto

Organization

Osaka University Graduate School of Medicine

Division name

Geriatri Medicine

Zip code

Address

2-2, #B6, Yamada-oka, Suita, Osaka

TEL

06-6879-3852

Homepage URL

http://www.med.osaka-u.ac.jp/pub/geriat/www/index_g.html

Email

sugimoto@geriat.med.osaka-u.ac.jp

Institute

Geriatric & General Medicine, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Geriatric & General Medicine, Osaka University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

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

Date of disclosure of the study information

2013

Year

11

Month

01

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

2013

Year

08

Month

05

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

01

Day

Last follow-up date

2015

Year

12

Month

31

Day

Date of closure to data entry

2015

Year

12

Month

31

Day

Date trial data considered complete

2016

Year

12

Month

31

Day

Date analysis concluded

2016

Year

12

Month

31

Day

Other related information

Registered date

2013

Year

10

Month

30

Day

Last modified on

2017

Year

11

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014231