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NCT Number: NCT00377442

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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Antonio, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GK Activator (2)

Drug

100mg po

simvastatin

Drug

80mg po

Primary outcomes

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

    Time frame: Days 1, 8 and 15

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

    Time frame: Days 1, 8 and 15

Secondary outcomes

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

    Time frame: Days 1, 8 and 15

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

    Time frame: Days 1, 8 and 15

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

    Time frame: Days 1, 8 and 15

  4. AEs, laboratory parameters.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open-label Crossover Study to Investigate the Potential Interaction Between GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 18, 2006
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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