Diabetes Mellitus Type 2
Conditions
Brief summary
This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Interventions
DRUGGK Activator (2)
25-200mg po bid for 20 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adult patients, 18-75 years of age; * type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening.
Exclusion criteria
* type 1 diabetes mellitus; * treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening; * women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients at each dose who achieve FPG <100mg/dL. | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile. | At intervals throughout study |
| AEs, laboratory parameters. | Throughout study |
Countries
Estonia, Latvia, Mexico, United States
Outcome results
None listed