Placebo and Active Controlled Study of Rivoglitazone in Type 2 Diabetes
Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00143520
Collaborator
(none)
441
74
12
6
0.5
Study Details
Study Description
Brief Summary
This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
441 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Double-dummy, Placebo-controlled 26-week Dose-response Study of Rivoglitazone HCl (CS-011) With Active Comparator (Pioglitazone HCl) in Subjects With Type 2 Diabetes
Study Start Date
:
Dec 1, 2004
Actual Primary Completion Date
:
Dec 1, 2005
Actual Study Completion Date
:
Dec 1, 2005
Outcome Measures
Primary Outcome Measures
- Change in HbA1c []
Secondary Outcome Measures
- FPG, Lipids, hsCRP, Adiponectin []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Type 2 diabetes in male or female patients
-
Between 18 and 75 years of age
-
With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization
Exclusion Criteria:
-
Type 1 diabetics or type 2 diabetics currently on insulin therapy
-
Patients unwilling or unable to discontinue their anti-diabetic medication(s)
-
History of ketoacidosis
-
History of therapy with rosiglitazone, troglitazone, pioglitazone
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Columbiana | Alabama | United States | ||
| 3 | Huntsville | Alabama | United States | ||
| 4 | Muscle Shoals | Alabama | United States | ||
| 5 | Hot Springs | Arkansas | United States | ||
| 6 | Jonesboro | Arkansas | United States | ||
| 7 | Little Rock | Arkansas | United States | ||
| 8 | Searcy | Arkansas | United States | ||
| 9 | Sherwood | Arkansas | United States | ||
| 10 | Los Angeles | California | United States | ||
| 11 | Moreno Valley | California | United States | ||
| 12 | Sacramento | California | United States | ||
| 13 | San Diego | California | United States | ||
| 14 | San Mateo | California | United States | ||
| 15 | Santa Monica | California | United States | ||
| 16 | Torrance | California | United States | ||
| 17 | Vista | California | United States | ||
| 18 | West Hills | California | United States | ||
| 19 | Newark | Delaware | United States | ||
| 20 | Clearwater | Florida | United States | ||
| 21 | Cocoa Beach | Florida | United States | ||
| 22 | Jupiter | Florida | United States | ||
| 23 | Largo | Florida | United States | ||
| 24 | Miami | Florida | United States | ||
| 25 | New Port Richey | Florida | United States | ||
| 26 | Palm Harbor | Florida | United States | ||
| 27 | Pembroke Pines | Florida | United States | ||
| 28 | Tampa | Florida | United States | ||
| 29 | West Palm Beach | Florida | United States | ||
| 30 | Warner Robins | Georgia | United States | ||
| 31 | Chicago | Illinois | United States | ||
| 32 | Gurnee | Illinois | United States | ||
| 33 | Evansville | Indiana | United States | ||
| 34 | Lexington | Kentucky | United States | ||
| 35 | New Orleans | Louisiana | United States | ||
| 36 | Detroit | Michigan | United States | ||
| 37 | Livonia | Michigan | United States | ||
| 38 | Kansas City | Missouri | United States | ||
| 39 | Saint Louis | Missouri | United States | ||
| 40 | Bozeman | Montana | United States | ||
| 41 | Butte | Montana | United States | ||
| 42 | Great Falls | Montana | United States | ||
| 43 | Voorhees | New Jersey | United States | ||
| 44 | Rochester | New York | United States | ||
| 45 | Charlotte | North Carolina | United States | ||
| 46 | Statesville | North Carolina | United States | ||
| 47 | Winston-Salem | North Carolina | United States | ||
| 48 | Cincinnati | Ohio | United States | ||
| 49 | Columbus | Ohio | United States | ||
| 50 | Marion | Ohio | United States | ||
| 51 | Clinton | Oklahoma | United States | ||
| 52 | Oklahoma City | Oklahoma | United States | ||
| 53 | Tulsa | Oklahoma | United States | ||
| 54 | Medford | Oregon | United States | ||
| 55 | Philadelphia | Pennsylvania | United States | ||
| 56 | Pittsburgh | Pennsylvania | United States | ||
| 57 | Charleston | South Carolina | United States | ||
| 58 | Simpsonville | South Carolina | United States | ||
| 59 | Bristol | Tennessee | United States | ||
| 60 | Carrollton | Texas | United States | ||
| 61 | Conroe | Texas | United States | ||
| 62 | Houston | Texas | United States | ||
| 63 | Midland | Texas | United States | ||
| 64 | San Antonio | Texas | United States | ||
| 65 | Spring | Texas | United States | ||
| 66 | Sugar Land | Texas | United States | ||
| 67 | Norfolk | Virginia | United States | ||
| 68 | Richmond | Virginia | United States | ||
| 69 | Virginia Beach | Virginia | United States | ||
| 70 | Lakewood | Washington | United States | ||
| 71 | Olympia | Washington | United States | ||
| 72 | Renton | Washington | United States | ||
| 73 | Spokane | Washington | United States | ||
| 74 | Milwaukee | Wisconsin | United States |
Sponsors and Collaborators
- Daiichi Sankyo, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00143520
Other Study ID Numbers:
- CS0011-203
First Posted:
Sep 2, 2005
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by ,
,
Additional relevant MeSH terms: