Unique ID issued by UMIN | UMIN000010353 |
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Receipt number | R000009797 |
Scientific Title | An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes |
Date of disclosure of the study information | 2014/03/28 |
Last modified on | 2014/12/16 13:55:06 |
An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
An open label,randomized control study for the comparison of pliotropic effects between Glulisine and Glargine with type 2 diabetes
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
YES
To compare the pleiotropic effects including glucose metabolism on patients with type 2 Diabetes between Bolus First (insulin glulisine three times daily) and Basal First Insulin (insulin glargine at bedtime)
Efficacy
Confirmatory
Pragmatic
Not applicable
M values
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Numbered container method
2
Treatment
Medicine |
Insulin glulisine was Administered before every meals.
Insulin dose is adjusted every day based on the results of blood glucose self-measurement.
insulin glargine was Administered before every sleeps. Initial insulin dose is calculated from the following equation.
Insulin dose is adjusted every day based on the results of blood glucose self-measurement.
20 | years-old | <= |
Not applicable |
Male and Female
The subjects must satisfy the following conditions:
1) An age at the time of obtaining informed consentis more than 20 years old
2) Patients with type 2 diabetes, whose HbA1c is more than 7.4%.
3) Gender is unquestioned:
4) Patients who are admitted to the purpose of glycemic control more than two weeks
1.Hypersensitivity to components of the insulin glargine and insulin glulisine.
2.None Type 2 diabetes
3.Medical history and/or complication of diabetic ketoacidosis.
4.Medical history and/or complication of severe hypoglycemia.
5.severe infection, around surgery or severe trauma.
6.Patients who received the administration of insulin, DPP-4 inhibitors or GLP-1 analog formulation within 4 weeks.
7.Treatment with glucocorticoid.
8.Uncontrolled Hypertension(systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
9.Proliferative retinopathy or maculopathy.
10.History of malignancy.
11.Severe health problems not suitable for the study.
12.Patients participated in other clinical trials within one month before the study.
13.Cases that Physicians deem inappropriate as the target of the test.
40
1st name | |
Middle name | |
Last name | TAKAMURA Toshinari |
kanazawa University Graduate School of Medical Science.
Department of Disease control and homeostasis
13-1 Takara-machi, kanazawa, Ishikawa, Japan
076-265-2234
ttakamura@m-kanazawa.jp
1st name | |
Middle name | |
Last name | TAKAMURA Toshinari |
kanazawa University Graduate School of Medical Science.
kanazawa University Graduate School of Medical Science.
13-1 Takara-machi, kanazawa, Ishikawa
076-265-2234
ttakamura@m-kanazawa.jp
Department of Disease Control and Homeostasis,kanazawa University Graduate School of Medical Science.
Department of Disease Control and Homeostasis,kanazawa University Graduate School of Medical Science.
Self funding
NO
2014 | Year | 03 | Month | 28 | Day |
Unpublished
Completed
2011 | Year | 05 | Month | 17 | Day |
2011 | Year | 06 | Month | 01 | Day |
2014 | Year | 06 | Month | 01 | Day |
2014 | Year | 12 | Month | 01 | Day |
2013 | Year | 03 | Month | 29 | Day |
2014 | Year | 12 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009797
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