UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000025284 |
| Receipt No. | R000028991 |
| Scientific Title | The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas. |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2020/07/30 (Ver. 18) |
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| Basic information | ||
| Public title | The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas. | |
| Acronym | The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas | |
| Scientific Title | The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas. | |
| Scientific Title:Acronym | The relation between HbA1c level and duration of hypoglycemia in type 2 diabetes patients treated with sulfonylureas. | |
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| Condition | ||
| Condition | Type 2 diabetes | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To evaluate the association between hypoglycemia and glycemic control among patients taking sulfonylureas using new CGM system,Free style libre pro, which needs no calibration during 14 days wear. |
| Basic objectives2 | Others |
| Basic objectives -Others | Clinical research |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Association between time of hypoglycemic range(min/day) and levels of HbA1c |
| Key secondary outcomes | |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Single arm |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Uncontrolled |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 1 | |
| Purpose of intervention | Diagnosis | |
| Type of intervention |
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| Interventions/Control_1 | sensor insertion | |
| Interventions/Control_2 | ||
| Interventions/Control_3 | ||
| Interventions/Control_4 | ||
| Interventions/Control_5 | ||
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| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
| Interventions/Control_9 | ||
| Interventions/Control_10 | ||
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Type 2 diabetic patient
taking sulfonylureas HbA1c < 12% outpatient |
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| Key exclusion criteria | treated with insulin | |||
| Target sample size | 300 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Kobe University Hospital | ||||||
| Division name | Department of Internal Medicine, Division of Diabetes and Endocrinology | ||||||
| Zip code | 650-0017 | ||||||
| Address | 7-5-1 Kusunoki-Cho, Kobe , Japan | ||||||
| TEL | 81-78-382-5860 | ||||||
| hirota@med.kobe-u.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Kobe University Hospital | ||||||
| Division name | Department of Internal Medicine, Division of Diabetes and Endocrinology | ||||||
| Zip code | 650-0017 | ||||||
| Address | 7-5-1 Kusunoki-Cho, Kobe , Japan | ||||||
| TEL | 81-78-382-5860 | ||||||
| Homepage URL | |||||||
| hirota@med.kobe-u.ac.jp | |||||||
| Sponsor | |
| Institute | Division of Diabetes and Endocrinology,
Department of Internal Medicine, Kobe University Graduate School of Medicine |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Division of Diabetes and Endocrinology,
Department of Internal Medicine, Kobe University Graduate School of Medicine |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | Shinko hospital
Nishiwaki municipal hospital Kobe Rosai Hospital Hyogo brain and heart center Rokko island Konan hospital |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | the institutional review boards of Kobe University Graduate School of Medicine |
| Address | 7-5-1 Kusunoki-Cho, Kobe,Japan |
| Tel | 81-78-382-6669 |
| rinri@med.kobe-u.ac.jp | |
| 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 | 神戸大学医学部附属病院(兵庫県)
神鋼記念病院(兵庫県) 西脇市立西脇病院(兵庫県) 神戸労災病院(兵庫県) 兵庫県立姫路循環器病センター(兵庫県) 六甲アイランド甲南病院(兵庫県) |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13132 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13132 | ||||||
| Number of participants that the trial has enrolled | 300 | ||||||
| Results | The duration of hypoglycemia with glucose values of less than 70 mg/dL was 6.8 , 2.6 , 1.8 , 1.6 , and 0.4 min/h for HbA1c levels of no more than 6.4%, 6.5 to 6.9%, 7.0 to 7.4%, 7.5 to 7.9%, and 8.0% and over, respectively, and was significantly (P less than 0.0125) longer in the HbA1c no more than 6.4%, 6.5 to 6.9%, and 7.0 to 7.4% groups than in the 8.0% and more group. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | male 182 female 87, 69.0 years old, HbA1c 7.2% |
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| Participant flow | We analyzed CGM data of patients for whom at least 7 days of recorded data were available. |
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| Adverse events | none |
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| Outcome measures | The primary outcome of the study was the difference in the duration of hypoglycemia between HbA1c levels of 8.0% and more and either no more than 6.4%, 6.5 to 6.9%, 7.0 to 7.4%, or 7.5 to 7.9%. |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Last follow-up date |
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| Date of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| Date analysis concluded | |||||||
| Other | |
| Other related information | Completed |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028991 |
