Type 2 diabetes mellitus
Conditions
Interventions
investigational material(s)
Generic name etc : SYR-322
INN of investigational material : Alogliptin
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational ma
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Had been receiving as table dose and regimen of an Alfa-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase. Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4). Had HbA1c differences within 10.0% at the start of the screening phase (Week - 8 ) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase. Was receiving as pecific diet therapy and an exercise therapy ( if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).
Exclusion criteria
Exclusion criteria: Had received any antidiabetic drug other than Alfa-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Glycosylated Hemoglobin (Week 12) Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Glycosylated Hemoglobin, Fasting Plasma Glucose, Fasting C-peptide, Blood Glucose Insulin, Insulin, C-peptide and Glucagons Baseline and Weeks 2, 4, 6, 8 and 12 | — |
Outcome results
None listed