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Completed

NCT Number: NCT00266253

A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 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

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Adelaide, Australia

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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 30-75 years of age;
  • type 2 diabetes mellitus;
  • individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening.

Exclusion criteria

  • type 1 diabetes mellitus;
  • any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months

Treatment and study plan

GK Activator (2)

Drug

Escalating doses, po bid or qd for 12 weeks.

metformin

Drug

As prescribed, for 12 weeks

Primary outcomes

  1. HbA1c mean change from baseline compared with placebo.

    Time frame: Week 12

Secondary outcomes

  1. Additional parameters of glycemic and lipid control.

    Time frame: Week 12

  2. AEs, laboratory parameters.

    Time frame: Throughout study

  3. Pharmacokinetic and exposure-response relationship

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 16, 2005
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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