Diabetes Mellitus Type 2
Conditions
Brief summary
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. 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 or qd for 12 weeks.
DRUGMetformin
As prescribed, for 12 weeks
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; * individual maximal tolerated daily dose of metformin monotherapy for \>=3 months prior to screening.
Exclusion criteria
* type 1 diabetes mellitus; * any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c mean change from baseline compared with 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
Australia, Canada, Germany, Spain, United Kingdom, United States
Outcome results
None listed