Type 2 diabetes mellitus
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Key Criteria for inclusion The subject has been taking metformin at a stable dose regimen for at least 12 weeks prior to the initiation of the treatment period (Week 0). The subject has an HbA1c of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Exclusion criteria
Exclusion criteria: Key Criteria for exclusion The subject has taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0). The subject with a history or symptoms of lactic acidosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c change at the completion of treatment from baseline | — |