UMIN-CTR Clinical Trial

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

type-2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2009

Year

01

Month

30

Day

Last modified on

2012

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002020