Trial information
A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.
Status: Completed
Protocol number: NP20413
Sponsor: Hoffman-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label crossover study to investigate the potential interaction between GK Activator (2) and simvastatin in patients with type 2 diabetes
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. Target sample size is
30.
Study phase: I
Study type: Interventional; Treatment; Randomized; Open Label; Active; Crossover; Pharmacokinetics/dynamics study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. AUC0-inf of GK Activator (2) and simvastatin acid. Time frame: Days 1, 8 and 15
2. AUC0-6h of plasma glucose from pre-dose to 6h post-dose. Time frame: Days 1, 8 and 15
Key secondary outcomes: 1. AUC0-6h of GK Activator (2) and simvastatin acid Time frame: Days 1, 8 and 15
2. AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. Time frame: Days 1, 8 and 15
3. Cmin, tmin, Cmax, tmax, plasma glucose. Time frame: Days 1, 8 and 15
4. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 09/18/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
- San Antonio, TX
- Tacoma, WA
