UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024511
Receipt number R000028212
Scientific Title Crossover evaluation of anagliptin versus sitagliptin on blood glucose levels using continuous glucose monitoring system in insulin-treated type 2 diabetes.
Date of disclosure of the study information 2016/10/21
Last modified on 2018/11/12 08:45:17

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Basic information

Public title

Crossover evaluation of anagliptin versus sitagliptin on blood glucose levels using continuous glucose monitoring system in insulin-treated type 2 diabetes.

Acronym

Cross-Assist

Scientific Title

Crossover evaluation of anagliptin versus sitagliptin on blood glucose levels using continuous glucose monitoring system in insulin-treated type 2 diabetes.

Scientific Title:Acronym

Cross-Assist

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of Anagliptin and Sitagliptin on glucose fluctuations using CGM ( continuous glucose monitor)in type 2 diabetic patients with insulin therapy. In addition, to consider the impact on the C-peptide and glucagon, and to examine the relationship with glucose .

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

Comparison of mean amplitude of glycemic excursions (MAGE) between Anagliptin and Sitagliptin.

Key secondary outcomes

1. Comparison of index of glycemic variability by CGM between Anagliptin and Sitagliptin.
(1) Standard deviation (SD)
(2) Mean 24h glucose level
(3) Area under the curve (AUC) by blood glucose level >= 180mg/dL and time
(4) Area over the curve curve (AOC) by blood glucose level < 70mg/dL and time
(5) Maximal blood glucose level in 1 day
(6) Maximal blood glucose level at after breakfast, lunch and dinner
(7) Interquartile range (25%-75%) of blood glucose level

2. Comparison of blood glucose-related indicators by meal tolerance test between Anagliptin and Sitagliptin.
(1) blood glucose level (fasting, 30 minutes, one hour, two hour, incremental AUC0-2h, AUC0-2h)
(2) Glucagon level (fasting, 30 minutes, one hour, two hour, incremental AUC0-2h, AUC0-2h)
(3) C-peptide (fasting, delta 0-30 minutes, incremental AUC0-1h, incremental AUC0-2h)

3. Comparison of CGM and blood glucose-related indicators by meal tolerance test between before and after administration of Anagliptin or Sitagliptin.

4. Comparison of side effects and laboratory values (including the SMBG) between administration groups and their changes between before and after administration.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Anagliptin preceding group: Anagliptin 200mg/day (Day4-8), Sitagliptin 50mg/day(Day9-13)

Interventions/Control_2

Sitagliptin preceding group: Sitagliptin 50mg/day (Day4-8), Anagliptin 200mg/day (Day9-13)

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who meet all of the following items to the subject of this study .
(1) Patients hospitalized being diagnosed type 2 diabetes mellitus
(2) HbA1c of 7.0 % - 9.9%
(3) Patients on use insulin preparations
(4) 20 years of age or older (regardless of sex)
(5) Patients who provided a written informed concent to participants of this study

Key exclusion criteria

Even if meet the inclusion criteria, patients in conflict with any of the following conditions is not the subject of this study.
(1) patient with a history of hypersensitivity for Anagliptin and/or Sitagliptin
(2) patients with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes
(3) patients with severe infection, before or after surgery, or severe external injury
(4) women who are possibility of or during pregnancy, or lactating
(5) patients who can not stop the DPP-4 inhibitors after hospitalization
(6) patients who are taking insulin more than 40U of daily dose
(7) patients who are taking or being required GLP-1 receptor agonists
(8) patients who are inappropriate to participate in research determined by principal investigator or subinvestigator

Target sample size

16


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroji Kitazato

Organization

Omori Red Cross Hospital

Division name

Department of Diabetes and Endocrinology

Zip code


Address

4-30-1, Chuo, Ota-ku, Tokyo, Japan

TEL

03-3775-3111

Email

kitazato-tky@umin.net


Public contact

Name of contact person

1st name
Middle name
Last name Hiroji Kitazato

Organization

Omori Red Cross Hospital

Division name

Department of Diabetes and Endocrinology

Zip code


Address

4-30-1, Chuo, Ota-ku, Tokyo, Japan

TEL

03-3775-3111

Homepage URL


Email

kitazato-tky@umin.net


Sponsor or person

Institute

Omori Red Cross Hospital

Institute

Department

Personal name



Funding Source

Organization

Kowa Company.Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2016 Year 04 Month 27 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 21 Day

Last modified on

2018 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028212


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name