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

NCT00377442 | Completed Phase 1

• 1 other identifier: NP20413
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

• AUC0-inf of GK Activator (2) and simvastatin acid.

  Days 1, 8 and 15

• AUC0-6h of plasma glucose from pre-dose to 6h post-dose.

  Days 1, 8 and 15

Secondary Outcomes (4)

• AUC0-6h of GK Activator (2) and simvastatin acid

  Days 1, 8 and 15

• AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2.

  Days 1, 8 and 15

• Cmin, tmin, Cmax, tmax, plasma glucose.

  Days 1, 8 and 15

• AEs, laboratory parameters.

  Throughout study

Study Arms (3)

1

EXPERIMENTAL

Drug: GK Activator (2)

2

EXPERIMENTAL

Drug: Simvastatin

3

EXPERIMENTAL

Drug: GK Activator (2); Drug: Simvastatin

Interventions

GK Activator (2) DRUG

100mg po

1; 3

Simvastatin DRUG

80mg po

2; 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients aged 18-75 years;
• type 2 diabetes mellitus;
• untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2006
• First Posted: September 18, 2006
• Study Start: August 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (2)