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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

259

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia, 2050
      • Heidelberg, Australia, 3081
  • Bulgaria
      • Dimitrovgrad, Bulgaria, 6400
      • Pleven, Bulgaria, 5800
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1606
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • Ontario
      • London, Ontario, Canada, NGA 4V2
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
  • Croatia
      • Zagreb, Croatia, 10000
  • Germany
      • Bammental, Germany, 69245
      • Berlin, Germany, 10115
      • Essen, Germany, 45355
      • Giessen, Germany, 35385
      • Görlitz, Germany, 02826
      • Hamburg, Germany, 20249
      • Kuenzing, Germany, 94550
      • Nürnberg, Germany, 90402
      • Tann, Germany, 36142
  • Guatemala
      • Guatemala City, Guatemala, 01015
  • Hungary
      • Budapest, Hungary, 1083
      • Gyor, Hungary, 9024
      • Kecskemet, Hungary, 6000
  • Mexico
      • Chihuahua, Mexico, 31238
      • Cuernavaca, Mexico, 62270
      • Durango, Mexico, 34070
      • Mexico City, Mexico, 14050
      • Mexico City, Mexico, 11650
      • Mexico City, Mexico, 14610
      • Mexico-city, Mexico, 06700
  • Poland
      • Bialystok, Poland, 15-276
      • Gdansk, Poland, 80-757
      • Gorzow, Poland, 66-400
      • Krakow, Poland, 31-121
      • Wroclaw, Poland, 50-088
  • United States
    • California
      • Chula Vista, California, United States, 91910
      • Chula Vista, California, United States, 91911
      • Los Angeles, California, United States, 90057
      • Spring Valley, California, United States, 91978
      • West Hills, California, United States, 91307
    • Florida
      • Hollywood, Florida, United States, 33021
      • Kissimmee, Florida, United States, 34741
    • Georgia
      • Atlanta, Georgia, United States, 30308
    • Kansas
      • Arkansas City, Kansas, United States, 67005
    • Montana
      • Butte, Montana, United States, 59701
    • New York
      • Binghamton, New York, United States, 13901
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
      • Statesville, North Carolina, United States, 28625
      • Winston-salem, North Carolina, United States, 27103
    • Ohio
      • Springdale, Ohio, United States, 45246
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
    • Tennessee
      • Memphis, Tennessee, United States, 38119
    • Washington
      • Federal Way, Washington, United States, 98003
      • Renton, Washington, United States, 98055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: GK Activator (2)
Escalating doses bid
Drug: Metformin
As prescribed, in patients who were in study BM18249

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AEs, laboratory parameters, ECG.
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change from original baseline in HbA1c, FPG, lipid profile.
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 20, 2006

First Submitted That Met QC Criteria

April 20, 2006

First Posted (Estimate)

April 21, 2006

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC19794

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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