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Trial record 1 of 1 for:    340-012
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Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01993927
First Posted: November 25, 2013
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
To determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in patients with impaired glucose tolerance in the routine clinical setting.

Condition Intervention
Impaired Glucose Tolerance Drug: Voglibose

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Basen Tablets 0.2 / Basen Oral Disintegrant(OD) Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of adverse events [ Time Frame: From baseline to Week 72 ]
    The frequency of adverse events by type, seriousness, time to onset, etc. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.

  • Progression to Type 2 Diabetes Mellitus (T2DM) [ Time Frame: From baseline to Week 72 ]
    Estimate over time of the cumulative rate of progression to T2DM. Diagnostic criteria for 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


Secondary Outcome Measures:
  • Normalization of Impaired Glucose Tolerance(IGT) [ Time Frame: From baseline to Week 72 ]
    Estimate over time of the cumulative rate of "IGT normalization". IGT normalization" will be determined by the survey physician based on the results of the 75-g oral glucose tolerance test (OGTT), glucose metabolism markers, and other data.


Enrollment: 742
Study Start Date: November 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Voglibose Tablets / Voglibose OD Tablets
Other Name: Basen Tablets, AO-128

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 patients with impaired glucose tolerance in the routine clinical setting.

Subjects 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with impaired glucose tolerance
Criteria

Inclusion Criteria:

  • Patients 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/m2) (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: Patients with any of the following conditions or patients 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:

  • Patients 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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993927


Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01993927     History of Changes
Other Study ID Numbers: 340-012
JapicCTI-132304 ( Registry Identifier: JapicCTI )
First Submitted: November 19, 2013
First Posted: November 25, 2013
Last Update Posted: October 12, 2017
Last Verified: July 2014

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Voglibose
Inositol
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances