NCT00366379

Brief Summary

This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2006

Geographic Reach
4 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

August 16, 2006

Last Update Submit

November 1, 2016

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients at each dose who achieve FPG <100mg/dL.

    Throughout study

Secondary Outcomes (2)

  • Mean change in HbA1c and FPG from baseline to endpoint; absolute/relative changes in lipid profile.

    At intervals throughout study

  • AEs, laboratory parameters.

    Throughout study

Study Arms (5)

1

EXPERIMENTAL
Drug: GK Activator (2)

2

EXPERIMENTAL
Drug: GK Activator (2)

3

EXPERIMENTAL
Drug: GK Activator (2)

4

EXPERIMENTAL
Drug: GK Activator (2)

5

EXPERIMENTAL
Drug: GK Activator (2)

Interventions

GK Activator (2)DRUG

25-200mg po bid for 20 weeks

12345

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus treated with one oral antihyperglycemic agent for \>=3 months prior to screening.

You may not qualify if:

  • type 1 diabetes mellitus;
  • treatment with insulin, PPAR agonists or systemic corticosteroids during the 3 months prior to screening;
  • women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Chandler, Arizona, 85225, United States

Location

Unknown Facility

Oviedo, Florida, 32765, United States

Location

Unknown Facility

Nampa, Idaho, 83687, United States

Location

Unknown Facility

Evansville, Indiana, 47714, United States

Location

Unknown Facility

Butte, Montana, 59701, United States

Location

Unknown Facility

Canton, Ohio, 44718, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Greer, South Carolina, 29651, United States

Location

Unknown Facility

Midland, Texas, 79707, United States

Location

Unknown Facility

Richmond, Virginia, 23249, United States

Location

Unknown Facility

Tallinn, 10138, Estonia

Location

Unknown Facility

Tartu, 50406, Estonia

Location

Unknown Facility

Tartu, 50708, Estonia

Location

Unknown Facility

Tartu, 51014, Estonia

Location

Unknown Facility

Jelgava, 3001, Latvia

Location

Unknown Facility

Riga, 1002, Latvia

Location

Unknown Facility

Riga, 1038, Latvia

Location

Unknown Facility

Chihuahua City, 31238, Mexico

Location

Unknown Facility

Guadalajara, 44340, Mexico

Location

Unknown Facility

Guadalajara, 44650, Mexico

Location

Unknown Facility

Pachuca, 42086, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 21, 2006

Study Start

July 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

ES(4)ME(4)US(10)LA(3)