Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

NCT ID: NCT01993927

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 742 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-18
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of this study is to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

Detailed Description

This is a special drug use surveillance on long-term use of Voglibose (Basen) designed to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

Particioants will be patients with impaired glucose tolerance. The planned sample size is 1,000.

The usual adult dosage is 0.2 mg of voglibose administered orally three times daily immediately before each meal.

Conditions

Impaired Glucose Tolerance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Voglibose 0.2 mg or OD Tablets 0.2 mg

Voglibose 0.2 mg or OD Tablets 0.2 mg will be administered orally three times daily immediately before each meal.

Voglibose

Intervention Type: DRUG

Voglibose Tablets / Voglibose OD Tablets

Interventions

Voglibose

Voglibose Tablets / Voglibose OD Tablets

Intervention Type: DRUG

Other Intervention Names

Basen Tablets, AO-128

Eligibility Criteria

Inclusion Criteria

• Participants must meet all of the following criteria ([1] to [3]) to be included in this study:

1. Determined as having IGT (defined as fasting blood glucose < 126 mg/dL and 2-hour post 75-g oral glucose tolerance test [OGTT] blood glucose of 140-199 mg/dL) without improvement despite treatment with diet therapy and exercise therapy for 3-6 months

2. Meets any of the following conditions:

(i) Concurrently has hypertension*1 (ii) Concurrently has dyslipidemia*2 (iii) Is obese (BMI ≥25 kg/m^2) (iv) Has a family history of diabetes mellitus in relatives to the second degree as defined by Japanese law*3

3. Regularly visits the study site and can be observed for 72 weeks

• 1: Hypertension: Patients with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or patients on oral antihypertensive medication.
• 2: Dyslipidaemia: Participants with any of the following conditions or participants on oral antidyslipidemic medication
• Hyper LDL cholesterolemia (fasting LDL-cholesterol ≥140 mg/dL)
• Hypo HDL cholesterolemia (fasting HDL-cholesterol < 40 mg/dL)
• Hypertriglyceridemia (fasting triglyceride ≥150 mg/dL) *3: Relatives to the second degree of consanguinity refer to blood relatives who are the subject's "father or mother, grandfather or grandmother, brothers or sisters, children, or grandchildren." Note that these do not include spouse's relatives.

Exclusion Criteria

• Participants meeting either of the following criteria ([1] or [2]) will be excluded:

1. Previously diagnosed with diabetes mellitus

2. Has any contraindications to Basen as specified below:

(i) Severe ketosis, diabetic coma or precoma (ii) Severe infection, perioperative state, or serious trauma (iii) History of hypersensitivity to any ingredients of Basen

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Osaka, , Japan

Countries

Japan

Other Identifiers

JapicCTI-132304

Identifier Type: REGISTRY

Identifier Source: secondary_id

340-012

Identifier Type: -

Identifier Source: org_study_id