Unique ID issued by UMIN | UMIN000014140 |
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Receipt number | R000016469 |
Scientific Title | Efficacy and Safety of GLP-1 first therapy compared with Insulin GLP-1 relay therapy in type 2 diabetes with inadequate glucose control: a randomized, open-label, multicenter parallel-group study |
Date of disclosure of the study information | 2014/06/02 |
Last modified on | 2021/12/10 09:49:59 |
Efficacy and Safety of GLP-1 first therapy compared with Insulin GLP-1 relay therapy in type 2 diabetes with inadequate glucose control: a randomized, open-label, multicenter parallel-group study
Direct comparison of GLP-1 first therapy and Insulin-GLP-1 relay therapy.
Efficacy and Safety of GLP-1 first therapy compared with Insulin GLP-1 relay therapy in type 2 diabetes with inadequate glucose control: a randomized, open-label, multicenter parallel-group study
Direct comparison of GLP-1 first therapy and Insulin-GLP-1 relay therapy.
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism |
Others
NO
To confirm efficacy and safety of GLP-1 first therapy and Insulin GLP-1 relay therapy in type 2 diabetes with inadequate glucose control as introduction of injectable medicine.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Blood glucose control by change in FPG, 1,5-AG and HbA1c.
Achievement rate of HbA1c goals below 7%.
1 Change in physical findings by change of body weight, adipose mass, basal metabolism and waist circumference
2 Change in biochemical finding
3 Change in lipid metabolism (TC, HDL-C, TG)
Change in hepatic and renal function
4 Identification of predictors for improvement of glucose control
5 Upper limit of daily insulin dose which can be changed from insulin therapy to GLP-1 therapy
6 Adverse events
7 Change in hepatokine
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
Central registration
2
Treatment
Medicine |
GLP-1 first therapy
Liraglutide (6 months)
Insulin GLP-1 relay therapy
Insulin degludec from baseline to 3 month (3 months)
Liraglutide from 4 to 6 month (3 months)
20 | years-old | <= |
Not applicable |
Male and Female
Type 2 diabetes with HbA1c above 8%
No limitation in sex and in or out-patients.
Patients who have history of serious hypersensitivity to Liraglutide, Exenatide, Lixisenatide and insulin degludec.
Patients with type 1 diabetes or impaired glucose tolerance due to other specific mechanisms or diseases or gestational diabetes.
Patients with diabetic ketoacidosis
Patients who have history of severe hypoglycemia with coma or loss of consciousness
Patients with serious infection or severe traumatic injury
Patients with steroids as unstable daily dose.
Patients with unstable hypertension with medication like systolic blood pressure above 160 mmHg or diastolic blood pressure above 100mmHg.
Patients with severe hepatic failure or renal failure or cardiac disorder and identified inappropriate patients for this study by the physicians in charge.
Patients with proliferative retinopathy (excluding old proliferative retinopathy without necessary of intervention) and patients with maculopathy with necessary of intervention.
Patients who have history of malignancy
Excluding following patients
Patients who have history of cured basal cell tumor by appropriate treatment or uterocervical carcinoma in situ
Patients who have history of malignancy more than 1 year before and also have no reappearance
Patients who onset malignancy during the period of the study.
Patients with severe complication and identified inappropriate patients for this study by the physicians in charge.
The pregnant women or women having possibilities of being pregnant and the women with breast-feeding
Other patients who are identified inappropriate patients for this study by the physicians in charge.
120
1st name | Toshinari |
Middle name | |
Last name | Takamura |
Kanazawa university
Department of Disease Control and Homeostasis
920-8641
13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan
076-265-2234
ttakamura@m-kanazawa.jp
1st name | Toshinari |
Middle name | |
Last name | Takamura |
Kanazawa university
Department of Disease Control and Homeostasis
920-8641
13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan
076-265-2234
ttakamura@m-kanazawa.jp
Kanazawa university
Department of Disease Control and Homeostasis
Kanazawa university
Department of Disease Control and Homeostasis
Self funding
Innovative Clinical Research Center, Kanazawa University.
13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan
076-265-2049
rinri@adm.kanazawa-u.ac.jp
NO
2014 | Year | 06 | Month | 02 | Day |
https://kanazawa.esct.jp/kurea/Common/
Unpublished
https://kanazawa.esct.jp/kurea/Common/
120
The GLP-1 receptor agonist is overall effective without prior glycemic control with insulin in participants with poorly controlled type 2 diabetes. However, in participants with insulinopenic type 2 diabetes, prior glycemic control with insulin may overcome glucose toxicity-induced GLP-1 resistance.
2021 | Year | 12 | Month | 10 | Day |
The median age of the participants in FAS was 61.0 years BMI 25.8 diabetes duration 4.0 years and baseline levels for FPG, HbA1c, and CPR 210.0 mg/dl 9.8%, and 2.2 ng/mL, respectively. Microalbuminuria was present in 17 out of 116 for this study. No study participant experienced macroalbuminuria. As the percentage of newly diagnosed with diabetes is 33.6% of this study, the participants have no or mild diabetic complications such as diabetic nephropathy.
In total, 120 individuals participated in the study (n = 60 in the insulin-GLP-1 RA relay group, n = 60 in the GLP-1 RA first group). Of these, 91 took the study medication up to week 24, whereas 13 discontinued it due to an adverse event (n = 7 in the insulin-GLP-1 RA relay group, n = 2 in the GLP-1 RA first group) or withdrew participation (n = 3 in the insulin-GLP-1 RA relay group, n = 1 in the GLP-1 RA first group). During follow-up, 12 were lost (n = 3 in the insulin-GLP-1 RA relay group, n = 9 in the GLP-1 RA first group).
Concerning adverse events, gastrointestinal issues such as nausea, abdominal distension, constipation, and diarrhea were the most common and occurred more frequently in the GLP-1 RA first group than in the insulin-GLP-1 RA relay group, followed by hypoglycemia in the insulin GLP1 RA relay group.
At 24 weeks, the FPG levels significantly decreased from baseline for the insulin-GLP-1 RA relay group (215.0 to 126.0 mg/dL, ) and GLP-1 RA first group (204.0 to 131.5 mg/dL), with no significant differences between groups (-68.0 mg/dL in the insulin-GLP-1 RA relay group, -43.0 mg/dL in the GLP-1 RA first group, p = 0.155). Similarly, the HbA1c levels significantly decreased from baseline for the insulin-GLP-1 RA relay group (9.8% to 6.5%) and the GLP-1 RA first group (9.7% to 6.8%), with no significant differences between groups (-2.8% in the insulin-GLP-1 RA relay group, -2.1% in the GLP-1 RA first group, p = 0.286). The differences between the groups for these primary clinical outcomes were unremarkable.
Completed
2014 | Year | 06 | Month | 02 | Day |
2013 | Year | 04 | Month | 16 | Day |
2014 | Year | 06 | Month | 02 | Day |
2019 | Year | 05 | Month | 30 | Day |
2019 | Year | 12 | Month | 31 | Day |
2019 | Year | 12 | Month | 31 | Day |
2014 | Year | 06 | Month | 02 | Day |
2021 | Year | 12 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016469
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2017/12/05 | 140718-ノボIRB研究計画.doc |
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