UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019353
Receipt number R000022381
Scientific Title Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist
Date of disclosure of the study information 2015/10/14
Last modified on 2017/02/22 16:08:50

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Basic information

Public title

Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist

Acronym

Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist

Scientific Title

Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist

Scientific Title:Acronym

Efficacy and safety of insulin glargine 300 U/ml versus 100 U/ml in type 2 diabetic patients treated with basal insulin plus GLP-1 receptor agonist

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 efficacy and safety between injecting insulin glargine 300 U/ml before breakfast and injecting insulin glargine 100 U/ml before breakfast in type 2 diabetic patients treated with a basal insulin and a GLP-1 receptor agonist

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

glucose-lowering effect evaluated with HbA1c levels after three-month treatment

Key secondary outcomes

- glucose-lowering effect evaluated with self-monitored blood glucose levels
- Subjective assessment of insulin injection
- Adverse events including hypoglycemia, weight gain, and other side effects


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

Injecting insulin glargine 100 U/ml before breakfast in period 1, and insulin glargine 300 U/ml before breakfast in period 2.

Interventions/Control_2

Injecting insulin glargine 300 U/ml before breakfast in period 1, and insulin glargine 100 U/ml before breakfast in period 2.

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

- adults with type 2 diabetes
- treated with a basal insulin
- treated with a GLP-1 receptor agonist (regardless of couse of oral hypoglycemic agents)

Key exclusion criteria

- patients injecting bolus insulin
- patients expected to have other antidiabetic agents added, changed, or increased/decreased in dosage during the next 6 months
- difficulty to perform self-monitoring blood glucose
- Patients with severe hepatic, renal, and/or cardiac disease
- Patients with hypersentitivity to the agents used in the current study
- Patients who are pregnant, breast-feeding or may become pregnant
- Patients who are judged by the investigator to be inappropriate for this study for any other reason.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihiko Shiraiwa

Organization

Shiraiwa Medical Clinic

Division name

Shiraiwa Medical Clinic

Zip code


Address

4-10-24 Hozenji, Kashiwara, Osaka 582-0005, Japan

TEL

072-971-1221

Email

shiraiwa@endmet.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshihiko Shiraiwa

Organization

Shiraiwa Medical Clinic

Division name

Shiraiwa Medical Clinic

Zip code


Address

4-10-24 Hozenji, Kashiwara, Osaka 582-0005, Japan

TEL

072-971-1221

Homepage URL


Email

shiraiwa@endmet.med.osaka-u.ac.jp


Sponsor or person

Institute

Shiraiwa Medical Clinic

Institute

Department

Personal name



Funding Source

Organization

Shiraiwa Medical Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Osaka University Graduate School of Medicine

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 10 Month 14 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

Completed

Date of protocol fixation

2015 Year 09 Month 16 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 14 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

2015 Year 10 Month 14 Day

Last modified on

2017 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022381


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name