UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000041551 |
| Receipt No. | R000047419 |
| Scientific Title | Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes |
| Date of disclosure of the study information | 2020/08/25 |
| Last modified on | 2021/08/26 (Ver. 3) |
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| Basic information | ||
| Public title | Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes
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| Acronym | Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes | |
| Scientific Title | Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes | |
| Scientific Title:Acronym | Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes | |
| Region |
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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 | Comparison of efficacy and safety of combination of insulin glargine and lixisenatide + glulisine therapy and intensive insulin therapy in patients with type 2 diabetes for hospitalization in a glycemic control.
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| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | efficacy:Percentage of time of the glucose level of euglycemic area (70-179 mg/dl) of flash glucose monitoring (FGM).
safety:Percentage of time less than 70 mg/dl (low blood glucose area) of FGM. |
| Key secondary outcomes | The percentage of time of the glucose level of hyperglycemic area (180 mg/dl or more), severe hypoglycemic area (less than 54 mg/dl) and nighttime (0 : 00-5: 59) hypoglycemic area in FGM.
Mean blood glucose (24hours, 0:00-6:00, 6:00-18:00, 18:00-24:00), SD value(24hours, 6:00-18:00), CV value(24hours, 6:00-18:00), percentage of time of the glucose level of euglycemic area (70-179 mg/dl of FGM(6:00-24:00), daily variation , M value, MAGE, changes in glycoalbumin levels,period until target blood glucose level is reached and titration is completed. |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Parallel |
| 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 |
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| Interventions/Control_1 | combination of insulin glargine and lixisenatide + glulisine therapy | |
| Interventions/Control_2 | intensive insulin therapy | |
| 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 |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | 1.Patients who have been diagnosed with type 2 diabetes more than 1 year before the start of the study and who have been treated with oral hypoglycemic drugs for more than 6 months before the screening.
2.Patients with glycated hemoglobin (HbA1c) levels of 7.0% or more and less than 11.0%. |
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| Key exclusion criteria | 1. Patients with severe gastrointestinal disorders such as severe gastroparesis.
2. Patients with a history of pancreatitis. 3. Patients with a history of severe ketosis, diabetic coma or pre-coma within 6 weeks of starting the study. 4.Patients with severe hypoglycemia (diabetic coma or precoma, convulsion that requires the assistance of a third party) within 6 weeks of starting the study. 5. Patients with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 or serum creatinine level 2.0mg/dL or more) or patients with end-stage renal failure undergoing dialysis. 6. Patients with severe liver dysfunction (AST or ALT higher than 100U/L). 7. Patients with proliferative retinopathy (however, patients with stable symptoms who have undergone photocoagulation, etc. can be enrolled). 8. Pregnant or possibly pregnant women and lactating patients. 9. Patients with severe infections, serious injury before and after surgery. 10. Patients receiving systemic corticosteroids. 11. Patients with a history of allergies to the planned drug used in the study. 12. Patients with or history of malignancy. 13.Other patients who the investigator determined to be inappropriate as a subject. |
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| Target sample size | 20 | |||
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| Name of lead principal investigator |
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| Organization | Minami Osaka Hospital | ||||||
| Division name | Internal Medicine | ||||||
| Zip code | 5590012 | ||||||
| Address | 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan | ||||||
| TEL | 0666850221 | ||||||
| y.kawaguchi@minamiosaka.com | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Minami Osaka Hospital | ||||||
| Division name | Internal Medicine | ||||||
| Zip code | 5590012 | ||||||
| Address | 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan | ||||||
| TEL | 0666850221 | ||||||
| Homepage URL | |||||||
| y.kawaguchi@minamiosaka.com | |||||||
| Sponsor | |
| Institute | Minami Osaka Hospital |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Minami Osaka Hospital |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Minami Osaka Hospital |
| Address | 1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan |
| Tel | 0666850221 |
| y.kawaguchi@minamiosaka.com | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
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| Date of disclosure of the study information |
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| 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 | |
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| Baseline Characteristics | |
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| Plan to share IPD | |
| IPD sharing Plan description | |
| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Date trial data considered complete |
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| Date analysis concluded |
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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=R000047419 |
