UMIN-CTR Clinical Trial

Public title

Add-on or switch to repaglinide for type 2 diabetes with sitagliptin: Randomized controlled open-labelled trial.

Acronym

Add-on or switch to repaglinide for type 2 diabetes with sitagliptin.

Scientific Title

Add-on or switch to repaglinide for type 2 diabetes with sitagliptin: Randomized controlled open-labelled trial.

Scientific Title:Acronym

Add-on or switch to repaglinide for type 2 diabetes with sitagliptin.

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the efficacy and safety of combination therapy with sitagliptin and repaglinide in comparison with repaglinide monotherapy in type 2 diabetes whose sitagliptin 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 repaglinide.

Key secondary outcomes

Effects on glucagon and insulin secretion evaluated by meal loading test.

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

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 sitagliptin and
repaglinide

Interventions/Control_2

monotherapy with repaglinide

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

Type 2 diabetic patients whose HbA1c level is more than 6.9 % and less than 8.4% even after diet, exercise, and administration of sitagliptin 50 mg/day.
1) HbA1c level is more than 6.9 % and less than 8.4 % for 3 months.
2) The changes in HbA1c level is plus/minus 0.5 % for 3 months.
3) Continue diet and exercise therapy for more than 6 months.
4) Taking sitagliptin for more than 3 months.
5) Biguanide or thiazolidinedione user can be included but not to change dosage and not to add-on these drugs during trial period.
6) Those who can understand the instruction and agree on the written consent.

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 100 IU/L).
4) Patients who have serious kidney disease(Serum Cr level is more than 2.0 mg/dL).
5) Patients who have serious heart disease (patients who have apparent heart failure or myocardial infarction within 3 months).
6) Patients who have serious pancreatic
disease.
7) Patients with cancer.
8) Anemic patients (Hb level is less than 11g/dL).
9) Patients with thrombocytepenia (Platelet count is less than 100000/mm3)
10) Patients with serious diabetic complications including progressed
neuropathy and proliferative retinopathy.
11) Patietns with serious infection,
inflammation, or injury, preoperative or postoperative 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 have 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

Toho University Graduate School of Medicine.

Division name

Department of Diabetes, Metabolism, and Endocrinology

Zip code

Address

6-11-1 Omori-Nishi Ota-ku, Tokyo, 143-8541, Japan

TEL

03-3762-4151

Email

takahisa.hirose@med.toho-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Takahisa Hirose MD PhD

Organization

Toho University Graduate School of Medicine.

Division name

Department of Diabetes, Metabolism, and Endocrinology

Zip code

Address

6-11-1 Omori-Nishi Ota-ku, Tokyo, 143-8541, Japan

TEL

03-3762-4151

Homepage URL

Email

takahisa.hirose@med.toho-u.ac.jp

Institute

Toho University Graduate School of Medicine.

Institute

Department

Personal name

Organization

Toho University Graduate School of Medicine.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Toranomon Hospital

Name of secondary funder(s)

none

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

東邦大学医療センター大森病院(東京都)、虎の門病院(東京都)

Date of disclosure of the study information

2013

Year

08

Month

08

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

05

Month

17

Day

Date of IRB

Anticipated trial start date

2013

Year

08

Month

08

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

08

Month

08

Day

Last modified on

2017

Year

02

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013214