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

NCT01993927 | Completed Results

• 2 other identifiers: 340-012JapicCTI-132304
• Study Type: observational
• Target: 742
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Tolerance

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience at Least One Adverse Events

  Up to Week 72

• Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period

  Percentage of participants who occurred progression of T2DM during treatment period was reported. Diagnostic criteria for progression of T2DM are: (1) "Blood glucose ≥200 mg/dL at any time, morning fasting blood glucose ≥126 mg/dL, or 2-hour post 75-g (Oral Glucose Tolerance Test) blood glucose ≥200 mg/dL. (2) Two or more glucose measurements obtained on different days that meet the above-mentioned criteria, or (3) A single glucose measurement meeting the above-mentioned criteria if the patient meets any of the following conditions: (i) Has typical symptoms of diabetes mellitus (e.g., dry mouth, polydipsia, polyuria, weight loss) (ii) HbA1C ≥6.5% (JDS value) (iii) Obvious diabetic retinopathy.

  Up to Week 72

Secondary Outcomes (1)

• Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period

  Up to Week 72

Study Arms (1)

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.

Drug: Voglibose

Interventions

Voglibose DRUG

Voglibose Tablets / Voglibose OD Tablets

Also known as: Basen Tablets, AO-128

Voglibose 0.2 mg or OD Tablets 0.2 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with impaired glucose tolerance

You may qualify if:

• Participants must meet all of the following criteria (\[1\] to \[3\]) to be included in this study:
• 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
• 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
• Regularly visits the study site and can be observed for 72 weeks
• : Hypertension: Patients with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or patients on oral antihypertensive medication.
• : 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.

You may not qualify if:

• Participants meeting either of the following criteria (\[1\] or \[2\]) will be excluded:
• Previously diagnosed with diabetes mellitus
• 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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

voglibose; AO 128

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: November 18, 2009
• Primary Completion: August 31, 2013
• Study Completion: August 31, 2013
• Last Updated: December 4, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)