UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019033
Receipt number R000021905
Scientific Title Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM)
Date of disclosure of the study information 2015/09/17
Last modified on 2018/09/18 14:32:27

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Basic information

Public title

Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM)

Acronym

Comparison of glycemic variations in T2D, between metformin highdose group and combination of metformin and sitagliptin or linagliptin group as assessed by CGM

Scientific Title

Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM)

Scientific Title:Acronym

Comparison of glycemic variations in T2D, between metformin highdose group and combination of metformin and sitagliptin or linagliptin group as assessed by CGM

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the glycemic variability by using CGM in patients with type 2 diabetes who receinig the metformin(1,500mg) versus receing the metformin(750mg) and sitagliptin(50mg) or linagliptin(5mg).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glucose variability in CGM
1)Mean glucose levels
2)Standard deviations of glucose (SD)
3)MAGE
4)Time in hypoglycemia
5)Time in hyperglycemia
6)Area under the curve(AUC)
7)Magnitude of increase in glucose levels
8)The time to peak glucose levels from baseline after each meal

Key secondary outcomes

Pre-meal plasma glucose, 1 hour post prandial glucose, 2 hour post prandial glucose


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After more than 4 weeks of treatment at metformin (1500mg), it change to sitagliptin (50mg) or linagliptin (5mg) + metformin (750mg).

Interventions/Control_2

After more than 4 weeks of treatment at sitagliptin (50mg) or linagliptin (5mg) + metformin (750mg), it change to metformin (1500mg).

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Type 2 diabetes
2)Patients who are administrated dose of metformin (500-1,000 mg/day) for 2 weeks or more
3)HbA1c >= 7.0% and <10.0%
4) Patients who were on the diet therapy
5)Patients who give written informed consent to participate in this study on a voluntary basis after receiving and understanding a sufficient explanation of the study

Key exclusion criteria

1)Patients with type 1 diabetes
2)Patients with insulin therapy
3)Patients who take oral hypoglycemic agent other than metformin
4)Patients with severe acidosis or diabetic coma
5)Patients with infections, before and after surgery,and severe trauma
6)Patiens with severe liver disease
7)Patients with severe renal disease with a serum creatinine (Cr) level (mg/dL) >1.5
8)Patients with shock, heart disease (heart failure, myocardial infarction, pulmonary embolism), severe lung failure
9)Patients with malnutrition, starvation, debilitating condition, pituitary dysfunction, adrenal insufficiency
10)Patients have history of lactic acidosis
11)Heavy drinkers
12)Patients with dehydration, gastrointestinal disorders (diarrhea, vomiting,etc)
13)Cancer patients
14)Patients for the biguanide drug with a history of allergy, or with a history of other drug allergy
15)Potential pregnant patients or patient with who are breast feeding

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Takahashi

Organization

Jikei University School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine

Zip code


Address

3-25-8, Nishishinbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111

Email

hiro3431_6117@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Takahashi

Organization

Jikei University School of Medicine

Division name

Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine

Zip code


Address

3-25-8, Nishishinbashi, Minato-ku, Tokyo, Japan

TEL

03-3433-1111

Homepage URL


Email

hiro3431_6117@yahoo.co.jp


Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Diabetes Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2015 Year 09 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2012 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 18 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded

2018 Year 03 Month 22 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 16 Day

Last modified on

2018 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021905


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name