UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001671
Receipt No. R000002020
Scientific Title The comparative study of the effects of miglitol and voglibose (alpha-glucosidase inhibitors) on incretins secretion
Date of disclosure of the study information 2009/02/01
Last modified on 2012/05/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The comparative study of the effects of miglitol and voglibose (alpha-glucosidase inhibitors) on incretins secretion
Acronym The study of relationships between alpha-glucosidase inhibitors and incretins
Scientific Title The comparative study of the effects of miglitol and voglibose (alpha-glucosidase inhibitors) on incretins secretion
Scientific Title:Acronym The study of relationships between alpha-glucosidase inhibitors and incretins
Region
Japan

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

Objectives
Narrative objectives1 To compare the effcts of miglitol and voglibose (alpha-glucosidase inhibitors) on the secretions of GLP-1 and GIP after a mixed meal.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Coparisons of changes in plasma glucose, insulin, GLP-1 and GIP in response to a mixed meal before and after administration of miglitol or voglibose.
Key secondary outcomes HbA1c, body weight, BMI, serum levels of adiponectin, high-sense CRP and MCP-1 at baseline and 3 month aftrer administrations of miglitol or voglibose.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 miglitol 50 mg thrice a day
Interventions/Control_2 voglibose 0.3 mg thrice a day
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) at baseline, HbA1c 6.5%-8.0% and /or plasma glucose >= 200mg/dl
2) type-2 diabetes
3) a patient who can gave consents by him- or herself
Key exclusion criteria 1) type-1 diabetes
2) severe hepatic or renal disease
3) severe heart disease
4) having canceres
5) unstable diabetic retinpathy
6) having a condyion to be worsened by increase in intestinal gas
7) a woman who is nursing or pregnant
8) after gstrectomy
9) a patient who is judged as not appropriate for participation
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuma Narita
Organization Akita University School of Medicine
Division name Department of Endocrinology, Diabetes and Geriatric Medicine
Zip code
Address 1-1-1 Hondo, Akita-city, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takuma Narita
Organization Akita University School of Medicine
Division name Department of Endocrinology, Diabetes and Geriatric Medicine
Zip code
Address
TEL
Homepage URL
Email narita@med.akita-u.ac.jp

Sponsor
Institute Akita University School of Medicine
Department of Endocrinology, Diabetes and Geriatric Medicine
Institute
Department

Funding Source
Organization No
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
Address
Tel
Email

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
2009 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
To compare the effects of miglitol [an alpha-glucosidase inhibitor (AGI) absorbed in the intestine] and voglibose (an AGI not absorbed) on plasma glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP) levels, 26 and 24 Japanese type 2 diabetic patients were randomly assigned to receive miglitol or voglibose, respectively. After 12-week administration of both drugs, during 2-h meal tolerance test,
plasma glucose, serum insulin and total GIP were significantly decreased and active GLP-1 was significantly increased. Miglitol group showed a
significantly lower total GIP level than voglibose group. Miglitol, but not voglibose, significantly reduced body weight (BW). In all participants,
the relative change in BW was positively correlated with that of insulin significantly and of GIP with a weak tendency, but not of GLP-1. In conclusion, both drugs can enhance postprandial GLP-1 responses and reduce GIP responses. The significant BW reduction by miglitol might be
attributable to its strong GIP-reducing efficacy.
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
2008 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Narita T, Yokoyama H, Yamashita R, Sato T, Hosoba M, Morii T, Fujita H, Tsukiyama K, Yamada Y (2012) Comparisons of the effects of 12-week administration of miglitol and voglibose on the responses of plasma incretins after a mixed meal in Japanese type 2 diabetic patients. Diabetes Obes Metab;14:283-287.

Management information
Registered date
2009 Year 01 Month 30 Day
Last modified on
2012 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002020

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.