Unique ID issued by UMIN | UMIN000028313 |
---|---|
Receipt number | R000032405 |
Scientific Title | A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes. |
Date of disclosure of the study information | 2017/07/25 |
Last modified on | 2017/07/21 00:41:47 |
A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.
A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.
A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.
A prospective comparison between liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy in patients with non-insulin-dependent type2 diabetes.
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To compare liraglutide-plus-basal-insulin combined therapy and intensive insulin therapy for glucose lowering effect,body weight,frequency of the hypoglycemic onset,patients treatment satisfaction.
Efficacy
Confirmatory
The change from baseline in HbA1c after 24 weeks of treatment.
The change from baseline in bodyweight after 24 weeks of treatment.
DTSQs scale score(Diabetes Treatment Satisfaction Questionnaire)
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
Numbered container method
2
Treatment
Medicine |
Liraglutide-plus-basal-insulin combined therapy.
The antidiabetic agent allowed to combination in trial are metformin,pioglitazone, alpha glucosidase inhibitors.(It is only in case of use for more than 12weeks.)
The initial dose of liraglutide starts 0.3mg of subcutaneous injection a day and increases it in quantity with 0.6mg,0.9mg every week,while confirming a digestive symptom,should not exceed 0.9mg a day.
The dose of bolus insulin was reduced by one-of total bolus insulin dose at the time of liraglutide added in combination 0.3mg,0.6mg fourth,0.9mg.
Intensive insulin therapy.The antidiabetic agent allowed to combination in trial are metformin,pioglitazone,alpha glucosidase inhibitors.It is only in case of use for more than 12weeks.The adjustment of the insulin dose of the intensive insulin therapy assumes it the judgment of the investigator.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1.The subjects with HbA1c(NGSP)less than 10.0%.
2.The subjects with BMI more than 22kg/m2.
3.The subjects received in glucagon stimulation test for >3 months prior to trial screening,(more than CPR1.0ng/ml before test and also more than 2.0ng/ml after test,the subjects that there are few risks of hyperglycemia even if endogenous insulin secretion is kept and able to replaces bolus insulin with liraglutide.)
4.All subjects had been treated with intensive insulin therapy for >3 months,prior to trial screening.
5.Patients who can understand consent brief and other explanation documents having the ability of agreement about participation in this examination.
1.Patients with severe ketosis,diabetic coma,the former comatose or type 1 diabetes.
2.Patients with the serious infection,the perioperative period and the serious trauma.
3.Patients with severe renal dysfunction including the patients needing haemodialysis or peritoneal dialysis.
4.Patients with a history of hypersensitivity to liraglutide.
5.Patients with the pregnant woman or the woman who may be pregnant.
6.Patients with serious renal dysfunction,serious liver dysfunction,collagenous or a malignant tumor.
7.In addition,the patient who judged inappropriate by an attendant physician.
8.Patients who take dipeptide-peptidase4 inhibitor,sulfonylurea.
40
1st name | |
Middle name | |
Last name | Saki Yamamoto |
Showa University
Division of Diabetes,Metabolism and Endocrinology,Department
1-5-8 Hatanodai,Sinagawa-ku,Tokyo,japan.
0337848000
sakichakko@gmail.com
1st name | |
Middle name | |
Last name | Saki Yamamoto |
Showa University
Division of Diabetes,Metabolism and Endocrinology,Department
1-5-8 Hatanodai,Sinagawa-ku,Tokyo,japan.
0337848000
sakichakko@gmail.com
Showa University
Showa University school of medicine,Division of diabetes,metabolism
and endocrinology.
Self funding
NO
昭和大学付属東病院 Showa University higashi hospital
2017 | Year | 07 | Month | 25 | Day |
Unpublished
Completed
2015 | Year | 02 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 07 | Month | 21 | Day |
2017 | Year | 07 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032405
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