UMIN-CTR Clinical Trial

Public title

An open label, randomized control study for the comparison of effectiveness between biguanides and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes

Acronym

An open label, randomized control study for the comparison of effectiveness between biguanides and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes

Scientific Title

An open label, randomized control study for the comparison of effectiveness between biguanides and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes

Scientific Title:Acronym

An open label, randomized control study for the comparison of effectiveness between biguanides and Dipeptidyl peptidase-4 (DPP-4) inhibitor in people with type 2 diabetes

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To clarify the effects of biguanides and DPP-4 inhibitor on metabolic and cardiovascular parameters and the pleiotropic effects in people with type 2 diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The change of body composition
WC, BW, the amount of fat,the amount of muscle mass, and so on

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

biguanides

Interventions/Control_2

Dipeptidyl peptidase-4 inhibitor

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Type 2 diabetes
2)HbA1c >=6.5% during 8 weeks prior to the study
3)Treated with none or single oral hypoglycemic agent or insulin over 12 weeks prior to the study

Key exclusion criteria

1.Hypersensitivity to or contraindication of biguanides and alogliptin
2.Type 1 diabetes, gestational diabetes mellitus, secondary diabetes
3.Medical history and/or complication of diabetic ketoacidosis
4.Medical history and/or complication of severe hypoglycemia
5.Severe infection, before and after surgery, patients with severe trauma
6.Patients treated with metformin or alogliptin within 4 weeks before the start of treatment
7.Patients introduced or those undergoing systemic administration of steroids
8.unstable glycemic control
9.Patients with severe renal impairment, including patients requiring hemodialysis or peritoneal dialysis (Less than more than more than Ccr 30mL / expression Cockcraft, man serum creatinine >2.5mg/dL, woman serum creatinine >2.0mg/dL)
10.Severe hypertension (systolic blood pressure > 100mmHg or diastolic blood pressure > 160mmHg)
11.The patients with severe heart disease of congestive heart failure, myocardial infarction, unstable angina within one year onset
12.Proliferative retinopathy or macular edema requiring treatment
13.History of malignancy or the treatment of malignancy within 1 year
14.Serious complications (Grade 3 classification as a guide to adverse drug reactions Ministry of Health, Labour and Welfare)
15.During pregnancy and lactation.
16.Other cases physicians sharing test was deemed inappropriate as the subject of the study or investigator.

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Toshinari Takamura

Organization

Kanazawa University Graduate School of Medical Science

Division name

Department of Disease Control and Homeostasis

Zip code

Address

13-1 Takara-machi, Kanazawa, Ishikawa 920-8641, Japan

TEL

076-265-2231

Email

ttakamura@m-kanazawa.jp

Name of contact person

1st name
Middle name
Last name	Toshinari Takamura

Organization

Kanazawa University Graduate School of Medical Science

Division name

Department of Disease Control and Homeostasis

Zip code

Address

13-1 Takara-machi, Kanazawa, Ishikawa 920-8641, Japan

TEL

076-265-2231

Homepage URL

Email

ttakamura@m-kanazawa.jp

Institute

Kanazawa University Graduate School of Medical Science

Institute

Department

Personal name

Organization

Kanazawa University Graduate School of Medical Science

Organization

Division

Category of Funding Organization

Self funding

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

金沢大学附属病院

Date of disclosure of the study information

2013

Year

04

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

Completed

Date of protocol fixation

2013

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

01

Day

Last modified on

2015

Year

03

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012149