Diabetes Mellitus Type 2
Conditions
Brief summary
This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Interventions
DRUGGK Activator (2)
100mg po
DRUGSimvastatin
80mg po
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adult patients aged 18-75 years; * type 2 diabetes mellitus; * untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.
Exclusion criteria
* type 1 diabetes mellitus, or latent autoimmune diabetes in adults; * diabetic neuropathy, retinopathy or nephropathy; * patients treated with insulin or PPAR gamma agonist within 6 weeks of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-inf of GK Activator (2) and simvastatin acid. | Days 1, 8 and 15 |
| AUC0-6h of plasma glucose from pre-dose to 6h post-dose. | Days 1, 8 and 15 |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-6h of GK Activator (2) and simvastatin acid | Days 1, 8 and 15 |
| AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. | Days 1, 8 and 15 |
| Cmin, tmin, Cmax, tmax, plasma glucose. | Days 1, 8 and 15 |
| AEs, laboratory parameters. | Throughout study |
Countries
United States
Outcome results
None listed