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OpenTrials
Completed

NCT Number: NCT00316758

A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 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

Camperdown, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetic patients who have completed studies BM18248 or BM18249;
  • patients considered by the investigator to be suitable for long term treatment with GK Activator (2).

Exclusion criteria

  • type 1 diabetes mellitus;
  • women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Treatment and study plan

GK Activator (2)

Drug

Escalating doses bid

metformin

Drug

As prescribed, in patients who were in study BM18249

Primary outcomes

  1. AEs, laboratory parameters, ECG.

    Time frame: Throughout study

Secondary outcomes

  1. Mean change from original baseline in HbA1c, FPG, lipid profile.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 21, 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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