UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034778 |
|---|---|
| Receipt number | R000038256 |
| Scientific Title | Safety and efficacy of linagliptin for glycemic control in non-critically ill hospitalized patients with type 2 diabetes |
| Date of disclosure of the study information | 2018/11/05 |
| Last modified on | 2021/05/08 09:46:07 |
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Basic information
Public title
Safety and efficacy of linagliptin for glycemic control in non-critically
ill hospitalized patients with type 2 diabetes
Acronym
Safety and efficacy of linagliptin for glycemic control in non-critically
ill hospitalized patients
Scientific Title
Safety and efficacy of linagliptin for glycemic control in non-critically
ill hospitalized patients with type 2 diabetes
Scientific Title:Acronym
Safety and efficacy of linagliptin for glycemic control in non-critically
ill hospitalized patients
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficasy of linagliptin for glycemic control in hospitalized patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of target glucose rage
Key secondary outcomes
mean blood glucose (BG), glycemic variability (GV), percentage of hypoglycemia, percentage of BG over 200 mg/dl, side effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dulaglutide plus basal insulin group: this group receives linagliptin once daily with basal insulin once daily and supplemental dose of regular insulin. Study term is 7 days after hospitalization.
Interventions/Control_2
Basal insulin group: this group receives basal insulin once daily and supplermental dose of regular insulin during study term.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Recruited patients had a known history of type 2 diabetes (T2D) with a blood glucose (BG) between 140 and 400 mg/dL and a known history of T2D for over 3 months, and were treated diet alone, any combination of oral antidiabetic agents, or low-dose insulin
therapy.
Key exclusion criteria
Patients admitted to or expected to require ICU admission; Patients with basal-bolus insulin therapy, corticosteroid therapy,therapy of once weekly antidiabetic agents, clinically relevant gastrointestinal disease, impaired renal function (serum creatinine >3.0 mg/dL); and patients with a history of diabetic ketoacidosis and hyperglycemic crises pregnancy, or any mental condition rendering the subject unable to give informed consent.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobutoshi Fushimi |
Organization
Ichinomiyanishi Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL
0586480077
nobutoshi243@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsubara Akihiro |
Organization
Ichinomiyanishi Hospital
Division name
Research Planning Division
Zip code
Address
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL
0586480077
Homepage URL
nobutoshi243@yahoo.co.jp
Sponsor or person
Institute
Ichinomiyanishi Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 05 | Day |
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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038256
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
