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

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ClinicalTrials.gov Identifier: NCT00388986
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 16, 2006
First Posted Date  ICMJE October 17, 2006
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE October 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
  • AUC0-6h of plasma glucose [ Time Frame: Days -1, 6 and 12 ]
  • AUC0-12h of GK Activator (2) and metabolite. [ Time Frame: Days 6 and 12 ]
  • AUC0-tau of glyburide [ Time Frame: Days -1 and 6 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
AEs, laboratory parameters. [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus Type 2
Intervention  ICMJE
  • Drug: GK Activator (2)
    100mg po bid
  • Drug: Glyburide
    10-20mg po daily
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Glyburide
  • Experimental: 2
    Intervention: Drug: GK Activator (2)
  • Experimental: 3
    Intervention: Drug: Glyburide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2008)
18
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00388986
Other Study ID Numbers  ICMJE NP20194
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

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