Diabetes Mellitus Type 2
Conditions
Brief summary
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.
Interventions
DRUGGK Activator (2)
Escalating doses po bid
DRUGPlacebo
po bid
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adult patients 30-75 years of age; * type 2 diabetes mellitus for \>3 months before screening; * treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).
Exclusion criteria
* type 1 diabetes mellitus; * women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c mean change from baseline, compared to placebo. | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Additional parameters of glycemic and lipid control. | Week 12 |
| AEs, laboratory parameters. | Throughout study |
| Pharmacokinetic and exposure-response relationship | Throughout study |
Countries
Bulgaria, Croatia, Guatemala, Hungary, Mexico, Poland, United States
Outcome results
None listed