Clinical trial NCT01993927: Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"
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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impaired Glucose Tolerance
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 742
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with impaired glucose tolerance

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.

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

Primary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Events
timeFrame: Up to Week 72
measure: Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period
timeFrame: Up to Week 72
Secondary outcomes:
measure: Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period
timeFrame: Up to Week 72
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: