Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes mellitus, Type 2, High blood sugar, Hyperglycemia, Antihyperglycemic agents, CS-917
Brief summary
This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment
Interventions
DRUGCS-917
DRUGmetformin hydrochloride
DRUGpioglitazone
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Drug naive or newly diagnosed type 2 diabetic subjects: * Never received oral antihyperglycemic or insulin therapy or * No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and * No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and * No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening. * HbA1C\>6.7% and \< or = to 10% at screening
Exclusion criteria
* Current insulin therapy * Symptoms of poorly controlled diabetes * History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening * Serum bicarbonate \< or = to 19 meq/L * Serum creatinine (Scr) \> 1.4 mg/dL (females) or 1.5 mg/dL (males) * Contraindication to metformin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in HbA1C after 12 weeks compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset of efficacy of CS-917 | — |
| Safety and tolerability of CS-917 | — |
| Changes in other relevant glycemic and metabolic measures | — |
| Proportion of subjects achieving therapeutic response | — |
| Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia | — |
Countries
United States
Outcome results
None listed