UMIN-CTR Clinical Trial

Public title

Efficacy and safety of combination therapy with vildagliptin and nateglinide in type 2 diabetes.

Acronym

combination therapy of vildagliptin and nateglinide

Scientific Title

Efficacy and safety of combination therapy with vildagliptin and nateglinide in type 2 diabetes.

Scientific Title:Acronym

combination therapy of vildagliptin and nateglinide

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To comfirm the efficacy and safety of combination therapy with nateglinide and vildagliptin in comparison with vildagliptin monotherapy in type 2 diabetes whose nateglinide monotherapy is insufficiet.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparison of changes of HbA1c and meal loading test after 24 weeks treatment of combination therapy and monotherapy of vildagliptin

Key secondary outcomes

Comparison of frequency of hypoglycemic episodes during 24 weeks treatment of combination therapy and monotherapy of vildagliptin.

Effects on glucagon and insulin secretion evaluated by meal loading test

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

combination therapy with vildagliptin and nateglinide

Interventions/Control_2

monotherapy with vildagliptin

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

the patients whose HbA1c level is more than 6.5% and less than 8.4% even after diet, excise, and administration of nateglinide

Key exclusion criteria

1) type 1 diabetes
2) patients who has been prescribed sulfonylurea or alpha glucosidase inhibitor
3) patients who have serious liver disease (AST and/or ALT are more than 80IU/L)
4) patients who have serious kidney disease (Serum Cr is more than 1.5mg/dL)
5) patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months)
6) patients who have serious pancreatic disease
7) patients with cancer
8) anemic patients (Hb is less than 11g/dL)
9) patients with thrombocytepenia (Platelet count is less than 100000/mm3)
10) patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy
11) patietns with serious infection, inflammation, or injuary. pre- or post- operative state
12) patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus
13) patinets with chronic bowel diseases which have probability to induce malabsorption syndrome
14) patients who has the disease which is deteriorated with increase of gas in bowel
15) heavy alcohol drinker (patients who drink more than 480mL of Japanese Sake, 2L of beer, 180mL of whisky, 360mL of wine, or 360mL of Shochu per day)
16) patients who are pregnant, hope to be pregnant, or are in lactation period
17) patients who have viral infection (HBV,HCV)
18) patients who are not applicable to this study judged by the medical doctor.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Takahisa Hirose MD PhD

Organization

Juntendo University Graduate School of Medicine

Division name

Depart of Medicine, Metabolisam and Endocrinology

Zip code

Address

2-1-1 Hongo Bunkyo-ku Tokyo Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Juntendo University Graduate School of Medicine

Division name

Depart of Medicine, Metabolisam and Endocrinology

Zip code

Address

TEL

Homepage URL

Email

hirosemd@juntendo.ac.jp

Institute

Department of Medicine, Metabolism and Endocrinology, Juntendo University Graduate School of Medicine

Institute

Department

Personal name

Organization

Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine

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

Date of disclosure of the study information

2010

Year

09

Month

30

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

2010

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

2012

Year

01

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

08

Month

06

Day

Last modified on

2013

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004821