UMIN-CTR Clinical Trial

Public title

Metformin therapy for East Asian women with recent gestational diabetes mellitus and glucose abnormalities: a multicenter, randomized, open-label trial

Acronym

Metformin therapy for East Asian women with recent gestational diabetes mellitus and glucose abnormalities

Scientific Title

Metformin therapy for East Asian women with recent gestational diabetes mellitus and glucose abnormalities: a multicenter, randomized, open-label trial

Scientific Title:Acronym

Metformin therapy for East Asian women with recent gestational diabetes mellitus and glucose abnormalities

Region

Japan

Condition

Women with recent gestational diabetes mellitus (GDM) and glucose abnormalities, including impaired fasting glucose (IFG), or impaired glucose tolerance (IGT), or both (IFG, IGT) postpartum.

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine if a standard lifestyle intervention plus metformin is more effective than a standard lifestyle intervention alone in preventing type 2 diabetes mellitus in women with prior GDM with glucose abnormalities postpartum.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Period of progression to type 2 diabetes mellitus

Key secondary outcomes

1.Change in blood glucose and serum insulin levels determined by a 75g oral glucose tolerance test (OGTT)
2.Change in index of insulin sensitivity (Matsuda index) from baseline and at study end (24 months after initiation of therapy, or the final point to be observed)
3.Change in index of insulin resistance (HOMA-IR)from baseline and at study end (24 months after initiation of therapy, or the final point to be observed)
4.Change in index of beta-cell function (Disposition index, Insulinogenic index) from baseline and at study end (24 months after initiation of therapy, or the final point to be observed)
5.Change in blood pressure, lipid metabolism, and body weight from baseline
6.Improvement to normal glucose tolerance
7.Incidence rate of adverse events

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

<Standard lifestyle intervention alone>
The standard lifestyle intervention will include the provision of individual advice on diet and exercise for 24 months.
Patients diagnosed with diabetes will be withdrawn.

Interventions/Control_2

<Standard lifestyle intervention plus metformin >
The standard lifestyle intervention will include the provision of individual advice on diet and exercise. Treatment with metformin will be initiated at a dose of 500mg taken orally twice a day, and will be increased to 1500mg daily, unless gastrointestinal symptoms occur. Standard lifestyle intervention plus metformin therapy will continue for 24 months. Patients diagnosed with diabetes will be withdrawn.

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

Not applicable

Gender

Female

Key inclusion criteria

Women who:
(1)experienced GDM in a previous singleton pregnancy in the past 5 years. Postpartum metabolic abnormalities determined by a 75g OGTT, inclusive of prior GDM with IFG, IGT, or both (IFG, IGT) postpartum;
(2)can respond to the questionnaire in Japanese;
(3)are over 20 years of age;
(4)have a record of clinical data during pregnancy;
(5)own the Maternal and Child Health Handbook.

Key exclusion criteria

(1)currently lactating;
(2)planning to conceive in the next two years;
(3)a history of diabetes and prior use of metformin or insulin to treat diabetes;
(4)a history of lactic acidosis;
(5)renal impairment (serum creatinine (Cr) level >=1.2mg/dl, including dialysis patients);
(6)severe liver dysfunction (serum aspartate transaminase (AST) and/or aminotransferase (ALT) level exceeding more than a threefold increase in normal lab values);
(7)cardiac failure, cardiac infarction, pulmonary embolism, a high degree of failure in lung function, and hypoxemia;
(8)excessive alcohol intake;
(9)malnutrition, or are in a state of starvation or debility, or have pituitary malfunction or adrenal insufficiency;
(10)a history of hypersensitivity reaction to metformin or other biguanides;
(11)thyroid function that is not controlled by hyperthyroidism (serum free thyroxine (fT4) levels exceed normal lab values within three months);
(12)autoantibody-positive status (e.g. GAD, IA-2), or suspected diabetes mellitus associated with a mutation of mitochondrial DNA, maternally inherited diabetes and deafness (MIDD), or MODY (maturity-onset diabetes of the young);
(13) not considered eligible to participate in this study by the attending doctor due to other reasons.

Target sample size

210

Name of lead principal investigator

1st name
Middle name
Last name	Naoko Arata

Organization

National Center for Child Health and Development, Tokyo, Japan

Division name

Maternal Medicine

Zip code

Address

10-1,Okura,2 chome,Setagaya,Tokyo,157-8538,JAPAN

TEL

03-3416-0181(7011)

Email

boseinaika@ncchd.go.jp

Name of contact person

1st name
Middle name
Last name	Maki Kawasaki

Organization

National Center for Child Health and Development, Tokyo, Japan

Division name

Maternal Medicine

Zip code

Address

10-1,Okura,2 chome,Setagaya,Tokyo,157-8538,JAPAN

TEL

03-3416-0181(7954)

Homepage URL

Email

boseinaika@ncchd.go.jp

Institute

National Center for Child Health and Development, Tokyo, Japan

Institute

Department

Personal name

Organization

National Center for Child Health and Development, Tokyo, Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN

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

国立成育医療研究センター(東京都）、大阪府立母子保健総合医療センター(大阪府）

Date of disclosure of the study information

2015

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Enrolling by invitation

Date of protocol fixation

2015

Year

08

Month

31

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

01

Day

Last follow-up date

2020

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

12

Day

Last modified on

2016

Year

03

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021900