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

• ClinicalTrials.gov Identifier: NCT00377442
• Recruitment Status: Completed
• First Posted: September 18, 2006
• Last Update Posted: November 2, 2016
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: September 15, 2006
• First Posted Date: September 18, 2006
• Last Update Posted Date: November 2, 2016
• Study Start Date: August 2006
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 18, 2008)

• AUC0-inf of GK Activator (2) and simvastatin acid. [ Time Frame: Days 1, 8 and 15 ]
• AUC0-6h of plasma glucose from pre-dose to 6h post-dose. [ Time Frame: Days 1, 8 and 15 ]

• Original Primary Outcome Measures (submitted: September 15, 2006): Pk: AUC0-inf of GK Activator (2) and simvastatin acid. Pd: AUC0-6h of plasma glucose from pre-dose to 6h post-dose.

Current Secondary Outcome Measures (submitted: January 18, 2008)

• AUC0-6h of GK Activator (2) and simvastatin acid [ Time Frame: Days 1, 8 and 15 ]
• AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. [ Time Frame: Days 1, 8 and 15 ]
• Cmin, tmin, Cmax, tmax, plasma glucose. [ Time Frame: Days 1, 8 and 15 ]
• AEs, laboratory parameters. [ Time Frame: Throughout study ]

• Original Secondary Outcome Measures (submitted: September 15, 2006): Pk: AUC0-6h of GK Activator (2) and simvastatin acid; AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. Pd: Cmin, tmin, Cmax, tmax, plasma glucose. Safety: AEs, laboratory parameters.
• 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 Simvastatin in Patients With Type 2 Diabetes.
• Official Title: A Randomized, Open-label Crossover Study to Investigate the Potential Interaction Between GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes
• Brief Summary: This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) 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) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus Type 2

Intervention

• Drug: GK Activator (2)
  100mg po
• Drug: Simvastatin
  80mg po

Study Arms

• Experimental: 1
  Intervention: Drug: GK Activator (2)
• Experimental: 2
  Intervention: Drug: Simvastatin
• Experimental: 3
  Interventions:

  • Drug: GK Activator (2)
  • Drug: Simvastatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 18, 2008): 33
• Original Enrollment: Not Provided
• Actual Study Completion Date: April 2007
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• adult patients aged 18-75 years;
• type 2 diabetes mellitus;
• 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 within 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: NCT00377442
• Other Study ID Numbers: NP20413
• 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