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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034778
Receipt No. R000038256
Official scientific title of the study 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 2018/11/05

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Basic information
Official scientific title of the study Safety and efficacy of linagliptin for glycemic control in non-critically
ill hospitalized patients with type 2 diabetes
Title of the study (Brief title) 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 Nobutoshi Fushimi
Organization Ichinomiyanishi Hospital
Division name Department of Endocrinology and Diabetes
Address 1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL 0586480077
Email nobutoshi243@yahoo.co.jp

Public contact
Name of contact person Matsubara Akihiro
Organization Ichinomiyanishi Hospital
Division name Research Planning Division
Address 1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL 0586480077
Homepage URL
Email nobutoshi243@yahoo.co.jp

Sponsor
Institute Ichinomiyanishi Hospital
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 01 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.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


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