UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Glucose excursions in patients with type 2 diabetes treated with mitiglinide/voglibose versus glimepiride: A randomized cross-over trial
Title of the study (Brief title)	Glucose excursions with mitiglinide/voglibose versus glimepiride
Region	Japan

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

Objectives
Narrative objectives1	To evaluate glucose excursions and the frequency of hypoglycemia in patients with type 2 diabetes treated with mitiglinide/voglibose versus glimepiride
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Glycemic excursions and the frequency of hypoglycemic evaluated using CGM on the last day of both periods
Key secondary outcomes	Metabolic profile changes during MTT

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After receiving vildagliptin 100 mg, patients were randomized to have add-on therapy as either the fixed-dose combination drug mitiglinide/voglibose 10 mg/0.2 mg three times daily for a few days followed by glimepiride 1 mg once daily for several subsequent days
Interventions/Control_2	or vice versa
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with type 2 diabetes who were taking DPP-4 inhibitors and were admitted to the general hospital for glycemic control
Key exclusion criteria	patients with insulin dependent diabetes; known allergies to mitiglinide, voglibose, or glimepiride; hepatic dysfunction; renal dysfunction; use of corticosteroids; existing pregnancy; alcoholism; a history of severe hypoglycemic episodes; a history of diabetic ketoacidosis; diabetic retinopathy with a high risk of hemorrhage
Target sample size	20

Research contact person
Name of lead principal investigator	Kanta Fujimoto
Organization	Kobe City Medical Center General Hospital
Division name	Internal Medicine of Diabetes and Endocrinology
Address	2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, Japan
TEL	075-302-4321
Email	kantachi@kcho.jp

Public contact
Name of contact person	Kanta Fujimoto
Organization	Kobe City Medical Center General Hospital
Division name	Internal Medicine of Diabetes and Endocrinology
Address	2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, Japan
TEL	075-302-4321
Homepage URL
Email	kantachi@kcho.jp

Sponsor
Institute	Kitano Hospital
Institute
Department

Funding Source
Organization	none
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	北野病院（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2014 Year 10 Month 01 Day
Date of closure to data entry	2014 Year 10 Month 01 Day
Date trial data considered complete	2014 Year 10 Month 01 Day
Date analysis concluded	2014 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	The mean glucose levels in the mitiglinide/voglibose and glimepiride groups were almost equal. the mitiglinide/voglibose group showed a significantly lower SD of glucose, MAGE, M-value, CONGA-1 value, and AUC >10 mmol/L than the glimepiride group. Hypoglycemia was not observed with mitiglinide/voglibose, whereas it was observed 0.35 times per day with glimepiride.
Other related information

Management information
Registered date	2016 Year 11 Month 13 Day
Last modified on	2017 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028565