Trial information
A Drug-Drug Interaction Study of GK Activator (2) and Ethanol in Patients With Type 2 Diabetes.
Status: Completed
Protocol number: NP20130
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind crossover study to investigate the potential glucose-lowering interaction between ethanol and GK Activator (2) in patients with type 2 diabetes.
Brief summary: This study will assess the potential glucose-lowering, and pharmacokinetic, interaction between GK Activator (2) and ethanol, 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), b)40g ethanol solution and c)GK Activator (2) 100mg + ethanol 40g. 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 18.
Study phase: I
Study type: Interventional; Treatment; Randomized; Double Blind; Crossover; Pharmacokinetics/dynamics study
Condition: Diabetes Mellitus, Type 2
Intervention type: Drug
Intervention name: GK Activator (2)
Primary outcome: 1. Pd: AUC0-6h of plasma glucose from pre-dose to 6h post-dose. Pk: AUC0-6h of GK Activator (2) and ethanol; AUC0-inf of GK Activator (2) and ethanol.
Key secondary outcomes: 1. Pd: Cmin, tmin, Cmax, tmax, plasma glucose. Pk:CL/F Cmax, tmax, t1/2 of GK Activator (2) and ethanol. Safety: AEs, laboratory parameters.
Inclusion criteria:
- adult patients, 18-75 years of age;
- type 2 diabetes mellitus;
- untreated, or taken off anti-diabetic 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 months of screening;
- patients with a history of alcoholism.
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: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Denmark
Germany
