search
Back to results

A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GK Activator (2)
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patients 30-75 years of age; type 2 diabetes mellitus for >3 months before screening; treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications). Exclusion Criteria: type 1 diabetes mellitus; women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

5

Arm Description

Outcomes

Primary Outcome Measures

HbA1c mean change from baseline, compared to placebo.

Secondary Outcome Measures

Additional parameters of glycemic and lipid control.
AEs, laboratory parameters.
Pharmacokinetic and exposure-response relationship

Full Information

First Posted
December 15, 2005
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00266240
Brief Title
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GK Activator (2)
Intervention Description
Escalating doses po bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po bid
Primary Outcome Measure Information:
Title
HbA1c mean change from baseline, compared to placebo.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Additional parameters of glycemic and lipid control.
Time Frame
Week 12
Title
AEs, laboratory parameters.
Time Frame
Throughout study
Title
Pharmacokinetic and exposure-response relationship
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients 30-75 years of age; type 2 diabetes mellitus for >3 months before screening; treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications). Exclusion Criteria: type 1 diabetes mellitus; women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Springdale
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
City
Dimitrovgrad
ZIP/Postal Code
6400
Country
Bulgaria
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
City
Cuernavaca
ZIP/Postal Code
62250
Country
Mexico
City
Durango
ZIP/Postal Code
34070
Country
Mexico
City
Mexico City
ZIP/Postal Code
11650
Country
Mexico
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
City
Mexico City
ZIP/Postal Code
14610
Country
Mexico
City
Mexico-city
ZIP/Postal Code
06700
Country
Mexico
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Gdansk
ZIP/Postal Code
80-757
Country
Poland
City
Gorzow
ZIP/Postal Code
66-400
Country
Poland
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

We'll reach out to this number within 24 hrs