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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"

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ClinicalTrials.gov Identifier: NCT01993927
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : November 2, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment
Impaired Glucose Tolerance Drug: Voglibose

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.


Study Type : Observational
Actual Enrollment : 742 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Voglibose Tablets 0.2 / Voglibose Oral Disintegrant (OD) Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"
Actual Study Start Date : November 18, 2009
Actual Primary Completion Date : August 31, 2013
Actual Study Completion Date : August 31, 2013

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants Who Experience at Least One Adverse Events [ Time Frame: Up to Week 72 ]
  2. Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period [ Time Frame: Up to Week 72 ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period [ Time Frame: Up to Week 72 ]
    Percentage of participants who had normalization of Impaired Glucose Tolerance (IGT) during treatment period was reported. IGT normalization was determined by the survey physician based on the results of the 75-g oral glucose tolerance test (OGTT), glucose metabolism markers, and other data.



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


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


Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Study Director Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01993927     History of Changes
Other Study ID Numbers: 340-012
JapicCTI-132304 ( Registry Identifier: JapicCTI )
First Posted: November 25, 2013    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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