A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00388986
First received: October 16, 2006
Last updated: September 22, 2014
Last verified: September 2014

October 16, 2006
September 22, 2014
October 2006
July 2007   (final data collection date for primary outcome measure)
  • AUC0-6h of plasma glucose [ Time Frame: Days -1, 6 and 12 ] [ Designated as safety issue: No ]
  • AUC0-12h of GK Activator (2) and metabolite. [ Time Frame: Days 6 and 12 ] [ Designated as safety issue: No ]
  • AUC0-tau of glyburide [ Time Frame: Days -1 and 6 ] [ Designated as safety issue: No ]
Pd: AUC0-6h of plasma glucose from pre-dose to 6h post-dose. Pk: AUC0-12h of GK Activator (2) and metabolite on days 6 & 12, AUC0-tau of glyburide on days -1 and 6.
Complete list of historical versions of study NCT00388986 on ClinicalTrials.gov Archive Site
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Pd: Cmin, tmin, Cmax, tmax, plasma glucose. Pk: AUC0-6h, CL/F, Cmax, tmax, t1/2 of GK Activator (2) and metabolite on days 6 & 12, & of glyburide on days -1 and 6
Not Provided
Not Provided
 
A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
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.

This study will assess the potential pharmacodynamic and potential pharmacokinet ic interaction between GK Activator (2) and glyburide, in type 2 diabetes patien ts not adequately controlled with glyburide as standard prescribed therapy. Pati ents will enter the study taking a dose of glyburide (10-20mg po daily) as presc ribed 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. Th e anticipated time on study treatment is <3 months, and the target sample size i s <100 individuals.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: GK Activator (2)
    100mg po bid
  • Drug: Glyburide
    10-20mg po daily
  • Experimental: 1
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Glyburide
  • Experimental: 2
    Intervention: Drug: GK Activator (2)
  • Experimental: 3
    Intervention: Drug: Glyburide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2007
July 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00388986
NP20194
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP