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

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

Tracking Information

• First Submitted Date: October 16, 2006
• First Posted Date: October 17, 2006
• Last Update Posted Date: November 2, 2016
• Study Start Date: October 2006
• Actual Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.
• Current Secondary Outcome Measures (submitted: January 18, 2008): AEs, laboratory parameters. [ Time Frame: Throughout study ]
• Original Secondary Outcome Measures (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: A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
• Official 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus Type 2

Intervention

• Drug: GK Activator (2)
  100mg po bid
• Drug: Glyburide
  10-20mg po daily

Study Arms

• Experimental: 1
  Interventions:

  • Drug: GK Activator (2)
  • Drug: Glyburide
• Experimental: 2
  Intervention: Drug: GK Activator (2)
• Experimental: 3
  Intervention: Drug: Glyburide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 18, 2008): 18
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2007
• Actual Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00388986
• Other Study ID Numbers: NP20194
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hoffmann-La Roche
• Study Sponsor: Hoffmann-La Roche
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: November 2016