UMIN-CTR Clinical Trial

Public title

A Comparative Study of Insulin Secretagogue
(SU Agent) and Insulin sensitizers (TZD)

Acronym

Sulfonylurea vs Glitazone for HbA1c Reduction (SUGAR study)

Scientific Title

A Comparative Study of Insulin Secretagogue
(SU Agent) and Insulin sensitizers (TZD)

Scientific Title:Acronym

Sulfonylurea vs Glitazone for HbA1c Reduction (SUGAR study)

Region

Japan

Condition

Type2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of monotherapy with an insulin secretagogue (SU agent) or insulin sensitizers (TZD) on blood glucose (BG) control in patients with type 2 diabetes mellitus (DM) in whom the BG level is not well controlled only with diet and exercise.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The rate for achieving the HbA1c level of < 6.5% at Month 6

Key secondary outcomes

Secondary endpoints in Step 1
1)Change in the HbA1c level at Month 6.
2)Changes in the FPG level, fasting insulin level, lipid metabolism, body weight, BMI, blood pressure and BNP at Month 6.
Secondary endpoints in Step 2
1)The rate for achieving the HbA1c level of 6.5% in the total subjects in each randomized group in Step 1.
2)The rates for achieving the target HbA1c level in the monotherapy groups.
3)Change in the HbA1c level in the monotherapy groups.
4)Changes in the FPG level, fasting insulin level, lipid metabolism, body weight, BMI, blood pressure and BNP at Month 12.5.
5)Changes in the dose of the drug and the HbA1c level.
6)Medical economic evaluation (medical expenses, new expenses for treatment and tests/ examinations required at the onset of adverse reactions, drugs necessary for lowering the HbA1c level by 1%, and drugs and medical care necessary for improving the DTSQ score by 1 point).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

[Step 1]
The assigned study drug will be administered alone.
Insulin secretagogue (SU agent)
Treatment with the insulin secretagogue should be started at a half of the usual dose when the HbA1c level just before administration is &#61619; 6.5% to < 7.0%, and at the usual dose when the HbA1c level is &#61619; 7.0% to < 10.0%. Thereafter, the dose should be adjusted as necessary for achieving the morning FPG level of < 120 mg/dL.
[Step 2]
Combination therapy will be started or monotherapy will be continued according to the directions in Table 1 taking account of an evaluation of the HbA1c level at Month 6 and the dose level of the study drug. The treatment method is as follows: The maximum doses of the insulin secretagogue (SU agent) and insulin sensitizer (TZD) are the same as those specified for Step 1.
(1)When monotherapy with the insulin secretagogue (SU agent) is continued
The dose should be adjusted for achieving the morning FPG level of < 120 mg/dL.
If the subjects do not achieve the HbA1c < 6.5% after reaching the maximum dose during the treatment period, coadministration with the insulin sensitizer (TZD) should be started as in Item (2).
(2)When the insulin secretagogue (SU agent) is combined with the insulin sensitizer (TZD)
The dose of the insulin sensitizer (TZD) should be adjusted for achieving the morning FPG level of < 120 mg/dL.

Interventions/Control_2

[Step 1]
The assigned study drug will be administered alone.
Insulin sensitizer (TZD)
The doses of pioglitazone should be as follows: 15 mg/day as the starting dose, 30 mg/day as the usual dose, 45 mg/day as the maximum dose for men, and 30 mg/day as the maximum dose for women.
The dose should be adjusted for achieving the morning FPG level of < 120 mg/dL.
[Step 2]
Combination therapy will be started or monotherapy will be continued according to the directions in Table 1 taking account of an evaluation of the HbA1c level at Month 6 and the dose level of the study drug. The treatment method is as follows: The maximum doses of the insulin secretagogue (SU agent) and insulin sensitizer (TZD) are the same as those specified for Step 1.
(1)When the insulin sensitizer (TZD) is combined with the insulin secretagogue (SU agent)
The dose of the insulin secretagogue (SU agent) should be adjusted for achieving the morning FPG level of < 120 mg/dL.
(2)When monotherapy with the insulin sensitizer (TZD) is continued
The dose should be adjusted for achieving the morning FPG level of < 120 mg/dL.
If the subjects do not achieve the HbA1c level of < 6.5% after reaching the maximum dose during the treatment period, coadministration with the insulin secretagogue should be started as in Item (1).

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

30

years-old

<=

Age-upper limit

73

years-old

>

Gender

Male and Female

Key inclusion criteria

At preliminary registration
(1)Being treated only with dietary management and/or therapeutic exercise.
(2)HbA1c >= 6.5% to < 10.0% at preliminary registration.
(3)Age at treatment initiation:
30 to 73 years*
(4)Sex: Male and female
(5)Inpatient or outpatient
(6)Being capable of providing informed consent to participate in the study, reading the informed consent document and understanding its contents.
At formal registration
(1)Being treated only with diet and exercise.
(2)HbA1c >= 6.5% to < 10.0% at formal registration
(3)A < 1.0% difference in HbA1c from the level at preliminary registration.

Key exclusion criteria

At preliminary registration
(1)Type 1 DM
(2)The use of insulin preparations or oral hypoglycemic agents (including a-GI) within 4 weeks prior to the start of observation period.
(3)Cardiac failure at present or in the past
(4)Concurrent serious cardiac, renal, hepatic, pancreatic or blood disease.
(5)Women who are pregnant, wishing to become pregnant, or lactating.
(6)Excessive alcohol drinking.
(7)Past history of drug allergies.
(8)Those who are participating in other clinical studies (excluding epidemiological studies).
(9)Those who are determined inappropriate for the study by the investigator.
At formal registration
(1)The use of insulin preparations or oral hypoglycemic agents (including a-GI) within 4 weeks prior to the start of observation period.
(2)Cardiac failure at present or in the past
(3)Concurrent serious cardiac, renal, hepatic, pancreatic or blood disease.
(4)Women who are pregnant, wishing to become pregnant, or lactating.
(5)Excessive alcohol drinking.
(6)Past history of drug allergies.
(7)Those who are participating in other clinical studies (excluding epidemiological studies).
(8)Those who are determined inappropriate for the study by the investigator.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Masashi Kitaoka

Organization

Japan Association for Diabetes Education and Care

Division name

Academic Committee

Zip code

Address

4-2-1 Kojimachi Chiyoda-ku Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name	Nobuyuki Shihara

Organization

Japan Association for Diabetes Education and Care

Division name

secretariat

Zip code

Address

4-2-1 Kojimachi Chiyoda-ku Tokyo

TEL

03-3514-1721

Homepage URL

http://www.nittokyo.or.jp/chousakenkyu_10001.html

Email

shihara@nittokyo.or.jp

Institute

Japan Association for Diabetes Education and Care

Institute

Department

Personal name

Organization

Sanofi Aventis

Organization

Division

Category of Funding Organization

Profit organization

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

2010

Year

11

Month

18

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

Completed

Date of protocol fixation

2007

Year

07

Month

13

Day

Date of IRB

Anticipated trial start date

2007

Year

09

Month

01

Day

Last follow-up date

2010

Year

01

Month

01

Day

Date of closure to data entry

2010

Year

02

Month

01

Day

Date trial data considered complete

2010

Year

03

Month

01

Day

Date analysis concluded

2010

Year

09

Month

01

Day

Other related information

Registered date

2010

Year

11

Month

18

Day

Last modified on

2010

Year

11

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005474