Type 2 diabetes mellitus
Conditions
Sponsors
Astellas Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has been diagnosed with type 2 diabetes mellitus for at least 12 weeks at informed consent. 2. Subject with hemoglobin A1c (HbA1c) value between 7.0 and 10.0 at screening. 3. Subject with a difference of HbA1c values within +/-1 in past 3 months before screening. 4. Subject with a body mass index (BMI) between 20.0 kg/m2 and 35.0 kg/m2 at screening. BMI = body weight (kg) / (height(m))2
Exclusion criteria
Exclusion criteria: 1. Subject has been receiving either of insulin therapy, sulfonylureas and insulin-stimulating agents at screening, or plans to receive any of these by the follow-up period of this study. 2. Subject plans to change the dietary therapy which has been taken until screening or to newly start the dietary therapy by the end of follow-up period of this study. 3. Subject has periodic exercise in the past six months before informed consent. 4.Subject applies to either of below at informed consent, screening or randomization; - Type 1 diabetes mellitus - complication of diabetic retinopathy except for simple retinopathy, other retinal neovascularization lesions or retinal complication treated by laser photocoagulation within six months - complication of diabetic nephrology at Stage III or more - complication of diabetic neuropathy - complication of severe high blood pressure - history or complication of severe cardiac disorder - history or complication of cerebral vascular disorder - history or complication of peripheral occlusive arterial disease - complication of musculoskeletal disorders - complication of respiratory disorders - complication of acute or severe infectious disease - complication of severe immune disorder which requires steroid or immunosuppressant therapy - complication or history of malignancy. 5. Subject has either of below at screening or randomization - Sitting systolic blood pressure >= 160 mmHg - Sitting diastolic blood pressure >= 100 mmHg - Sitting pulse rate >= 130 beats/min - 12-lead electrocardiogram (12-ECG) >= Grade 2 defined in the classification criteria for severity of adverse drug reactions 6. Subject has either of below at screening; - Brain natriuretic peptide (BNP) >= 100 pg/mL - Fasting plasma glucose >= 250 mg/dL - Positive urinary ketone bodies >= moderate level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline in HbA1c Up to Week 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline in biochemistry values in plasma (fasting plasma glucose, glycoalbumin, fasting serum insulin, triglyceride, low density lipoprotein and high density lipoprotein cholesterol) Up to Week 13 efficacy Change from baseline in HOMA-R (fasting plasma glucose x fasting serum insulin / 405) Up to Week 13 efficacy Change from baseline in HOMA-beta (fasting serum insulin x 360 / (fasting plasma glucose - 63)) Up to Week 13 efficacy Change from baseline in muscle mass Up to Week 12 efficacy Change from baseline in body fat percentage Up to Week 12 efficacy Change from baseline in waist circumference Up to Week 13 efficacy Change from baseline in body weight Up to Week 13 efficacy Change from baseline in SF-36 (Medical Outcomes Trust Short-Form 36-item v2) Up to Week 13 efficacy Change from baseline in blood pressure Up to Week 13 safety Safety assessed by incidence of adverse events Up to Week 15 | — |
Countries
Japan
Outcome results
None listed