UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of long-acting insulin dose corresponding to lixisenatide dose in combination therapy of insulin and lixisenatide
Title of the study (Brief title)	Evaluation of long-acting insulin dose corresponding to lixisenatide dose
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the corresponding doses of long-acting insulin to two different lixisenatide doses (regular dose: 20ug/day and a half dose: 10ug/day) when the two drugs are used in combination. The changes in daily insulin dose, HbA1c, blood glucose levels, body weight, and frequency of hypoglycemia will be examined.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in daily insulin dose of insulin glargine at 12 and 24 weeks
Key secondary outcomes	Changes in blood glucose levels (average, SD value, MAGE value), HbA1c, body weight, and frequency of hypoglycemia at 4, 8, 12 and 24 weeks.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	24Weeks Lixisenatide 20ug once daily+Glargine/Detemir once daily
Interventions/Control_2	24Weeks Lixisenatide 10ug once daily+Glargine/Detemir once daily
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with type 2 diabetes who are injecting basal insulin (glargine or detemir) or premixed insulin SID or BID. 2. Age >20 years old
Key exclusion criteria	1. The patients who did not agree with this study 2. The patients with serious complications 3. The patients who are at high risk for hypoglycemia 4. The patients who have the history of severe hypoglycemia (needed an emergency transport according to the hypoglycemia unawareness) 5. Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshiyuki Hamamoto
Organization	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name	Center for Diabetes and Endocrinology
Address	2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL	06-6312-1221
Email	hamamoto@kitano-hp.or.jp

Public contact
Name of contact person	Yoshiyuki Hamamoto
Organization	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name	Center for Diabetes and Endocrinology
Address	2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL	06-6312-1221
Homepage URL
Email	hamamoto@kitano-hp.or.jp

Sponsor
Institute	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization	Center for Diabetes and Endocrinology, Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 10 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 26 Day
Anticipated trial start date	2013 Year 09 Month 10 Day
Last follow-up date	2017 Year 03 Month 31 Day
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	2013 Year 10 Month 11 Day
Last modified on	2018 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013682