Type 2 Diabetes Mellitus
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes mellitus patients
Exclusion criteria
Exclusion criteria: 1. Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus 2. Have severe infection, perioperative status, or serious trauma 3. Have severe renal impairment or on dialysis due to end-stage renal disease 4. Have a history of hypersensitivity to any ingredients of this drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of Participants Who Had One or More Adverse Events Timeframe; 36 months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. safety Number of Participants Who Had One or More Adverse Drug Reactions Timeframe; 36 months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change from Baseline in Glycosylated Hemoglobin (HbA1c) Timeframe; Baseline, up to final assessment point (up to Month 36) The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement. efficacy Change from Baseline in Fasting Blood Glucose Timeframe; Baseline, up to final assessment point (up to Month 36) The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement. efficacy Change from Baseline in Fasting Insulin Level Timeframe; Baseline, up to final assessment point (up to Month 36) The reported data was the change in the mean value of fasting insulin collected between baseline and timepoints (up to final assessment point: Month 36). efficacy Change from Baseline in Homeostasis Model Assessment of beta-cell Function (HOMA-beta) Timeframe; Baseline, up to final assessment point (up to Month 36) The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) *360/ [fasting glucose (mg/dL) - 63]. efficacy Change from Baseline in Fasting Glucagon Timeframe; Baseline, up to final assessment point (up to Month 36) The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36). efficacy Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) Timeframe; Baseline, up to final assessment point (up to Month 36) The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 8.0 Percent) at bas | — |
Countries
Japan
Outcome results
None listed