Trial information
A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
Status: Completed
Protocol number: NP20194
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label, crossover study to investigate the potential pharmacodynamic and potential pharmacokinetic interaction between glyburide and GK Activator(2) in type 2 diabetes patients inadequately controlled with glyburide as standard prescribed therapy.
Brief summary: This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 18.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Crossover; Pharmacokinetics/dynamics study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. AUC0-6h of plasma glucose Time frame: Days -1, 6 and 12
2. AUC0-12h of GK Activator (2) and metabolite. Time frame: Days 6 and 12
3. AUC0-tau of glyburide Time frame: Days -1 and 6
Key secondary outcomes: 1. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, aged 18-75 years;
- type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for >=3 months;
- 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 with 6 weeks of screening.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 10/17/2006
Date last updated: 12/19/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Cypress, CA
- Honolulu, HI
- Buffalo, NY
- San Antonio, TX
