Impaired glucose tolerance (IGT)
Conditions
Interventions
investigational material(s)
Generic name etc : Basen Tablets / Basen OD Tablets (voglibose)
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administr
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion 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 = 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 = 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (adverse reactions), progression to type 2 diabetes mellitus* Primary timeframe 72 weeks Summary of frequency of adverse events (adverse drug reactions), and estimate over time of the cumulative rate of progression to type 2 diabetes mellitus. *Diagnostic criteria for type 2 diabetes mellitus (1) Blood glucose >= 200 mg/dL at any time, morning fasting blood glucose >= 126 mg/dL, or 2-hour post 75-g (OGTT) 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
| Measure | Time frame |
|---|---|
| Normalization of IGT Secondary timeframe 72 weeks 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 OGTT, glucose metabolism markers, and other data | — |
Outcome results
None listed