Diabetes Mellitus, Type 2 Clinical Trial
— REDWOOD403Official title:
A Phase III, Multicenter, Double-blind, Active-Controlled, 52 Week Extension Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone
| NCT number | NCT01089790 |
| Other study ID # | DUT-MD-403 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | March 17, 2010 |
| Last updated | September 14, 2011 |
| Start date | March 2010 |
This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).
| Status | Terminated |
| Enrollment | 141 |
| Est. completion date | |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 86 Years |
| Eligibility |
Inclusion Criteria: - Have successfully completed all required visits of a qualifying Phase 3 core protocol - Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol Exclusion Criteria: - Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Forest Investigative Site 039 | Akron | Ohio |
| United States | Forest Investigative Site 006 | Albany | New York |
| United States | Forest Investigative Site 101 | Albuquerque | New Mexico |
| United States | Forest Investigative Site 137 | Albuquerque | New Mexico |
| United States | Forest Investigative Site 061 | Anaheim | California |
| United States | Forest Investigative Site 152 | Anaheim | California |
| United States | Forest Investigative Site 099 | Arlington | Texas |
| United States | Forest Investigative Site 121 | Arlington | Virginia |
| United States | Forest Investigative Site 155 | Asheboro | North Carolina |
| United States | Forest Investigative Site 102 | Ashland | Oregon |
| United States | Forest Investigative Site 045 | Atlanta | Georgia |
| United States | Forest Investigative Site 079 | Augusta | Georgia |
| United States | Forest Investigative Site 035 | Baltimore | Maryland |
| United States | Forest Investigative Site 130 | Bensalem | Pennsylvania |
| United States | Forest Investigative Site 147 | Berkeley Heights | New Jersey |
| United States | Forest Investigative Site 083 | Bethany | Oklahoma |
| United States | Forest Investigative Site 020 | Birmingham | Alabama |
| United States | Forest Investigative Site 064 | Birmingham | Alabama |
| United States | Forest Investigative Site 156 | Boca Raton | Florida |
| United States | Forest Investigative Site 148 | Brandenton | Florida |
| United States | Forest Investigative Site 048 | Bristol | Tennessee |
| United States | Forest Investigative Site 003 | Brockton | Massachusetts |
| United States | Forest Investigative Site 055 | Brockton | Massachusetts |
| United States | Forest Investigative Site 163 | Cadillac | Michigan |
| United States | Forest Investigative Site 059 | Chandler | Arizona |
| United States | Forest Investigative Site 051 | Charlotte | North Carolina |
| United States | Forest Investigative Site 094 | Charlotte | North Carolina |
| United States | Forest Investigative Site 117 | Charlotte | North Carolina |
| United States | Forest Investigative Site 104 | Chattanooga | Tennessee |
| United States | Forest Investigative Site 114 | Chattanooga | Tennessee |
| United States | Forest Investigative Site 041 | Chula Vista | California |
| United States | Forest Investigative Site 023 | Cincinnati | Ohio |
| United States | Forest Investigative Site 073 | Clearwater | Florida |
| United States | Forest Investigative Site 115 | Colorado Springs | Colorado |
| United States | Forest Investigative Site 043 | Columbus | Ohio |
| United States | Forest Investigative Site 056 | Corpus Christi | Texas |
| United States | Forest Investigative Site 034 | Covington | Louisiana |
| United States | Forest Investigative Site 017 | Dallas | Texas |
| United States | Forest Investigative Site 071 | Dallas | Texas |
| United States | Forest Investigative Site 124 | Dallas | Texas |
| United States | Forest Investigative Site 057 | Dayton | Ohio |
| United States | Forest Investigative Site 004 | Daytona Beach | Florida |
| United States | Forest Investigative Site 002 | Dearborn | Michigan |
| United States | Forest Investigative Site 077 | Decatur | Georgia |
| United States | Forest Investigative Site 052 | DeLand | Florida |
| United States | Forest Investigative Site 088 | Denver | Colorado |
| United States | Forest Investigative Site 162 | Desoto | Texas |
| United States | Forest Investigative Site 042 | Dunwoody | Georgia |
| United States | Forest Investigative Site 135 | Durham | North Carolina |
| United States | Forest Investigative Site 054 | Edina | Minnesota |
| United States | Forest Investigative Site 049 | Encinitas | California |
| United States | Forest Investigative Site 078 | Erlanger | Kentucky |
| United States | Forest Investigative Site 005 | Eugene | Oregon |
| United States | Forest Investigative Site 097 | Evansville | Indiana |
| United States | Forest Investigative Site 100 | Evansville | Indiana |
| United States | Forest Investigative Site 113 | Gilbert | Arizona |
| United States | Forest Investigative Site 096 | Goodyear | Arizona |
| United States | Forest Investigative Site 013 | Grand Island | Nebraska |
| United States | Forest Investigative Site 022 | Greenbrae | California |
| United States | Forest Investigative Site 103 | Greer | South Carolina |
| United States | Forest Investigative Site 047 | Harbor City | California |
| United States | Forest Investigative Site 037 | Harleysville | Pennsylvania |
| United States | Forest Investigative Site 144 | Hialeah | Florida |
| United States | Forest Investigative Site 129 | Hollywood | Florida |
| United States | Forest Investigative Site 106 | Houston | Texas |
| United States | Forest Investigative Site 136 | Houston | Texas |
| United States | Forest Investigative Site 010 | Huntington Park | California |
| United States | Forest Investigative Site 014 | Irving | Texas |
| United States | Forest Investigative Site 139 | Irving | Texas |
| United States | Forest Investigative Site 062 | Jacksonville | Florida |
| United States | Forest Investigative Site 126 | Jenkintown | Pennsylvania |
| United States | Forest Investigative Site 053 | Kansas City | Kansas |
| United States | Forest Investigative Site 032 | Kettering | Ohio |
| United States | Forest Investigative Site 065 | Las Vegas | Nevada |
| United States | Forest Investigative Site 072 | Las Vegas | Nevada |
| United States | Forest Investigative Site 058 | Lenoir | North Carolina |
| United States | Forest Investigative Site 107 | Lexington | Kentucky |
| United States | Forest Investigative Site 070 | Los Angeles | California |
| United States | Forest Investigative Site 024 | Madisonville | Kentucky |
| United States | Forest Investigative Site 090 | Manning | South Carolina |
| United States | Forest Investigative Site 141 | Marion | Ohio |
| United States | Forest Investigative Site 159 | Marion | Ohio |
| United States | Forest Investigative Site 001 | Medford | Oregon |
| United States | Forest Investigative Site 009 | Meridian | Idaho |
| United States | Forest Investigative Site 050 | Miami | Florida |
| United States | Forest Investigative Site 122 | Miami | Florida |
| United States | Forest Investigative Site 154 | Miami | Florida |
| United States | Forest Investigative Site 157 | Miami | Florida |
| United States | Forest Investigative Site 161 | Miami | Florida |
| United States | Forest Investigative Site 125 | Miami Lakes | Florida |
| United States | Forest Investigative Site 027 | Milwaukee | Wisconsin |
| United States | Forest Investigative Site 038 | Morehead City | North Carolina |
| United States | Forest Investigative Site 158 | Morrisville | Pennsylvania |
| United States | Forest Investigative Site 025 | Muscle Shoals | Alabama |
| United States | Forest Investigative Site 118 | New Bedford | Massachusetts |
| United States | Forest Investigative Site 160 | New Braunfels | Texas |
| United States | Forest Investigative Site 081 | New Hyde Park | New York |
| United States | Forest Investigative Site 069 | New Port Richey | Florida |
| United States | Forest Investigative Site 016 | New York | New York |
| United States | Forest Investigative Site 151 | New York | New York |
| United States | Forest Investigative Site 149 | Norman | Oklahoma |
| United States | Forest Investigative Site 111 | Northridge | California |
| United States | Forest Investigative Site 012 | Ocala | Florida |
| United States | Forest Investigative Site 150 | Omaha | Nebraska |
| United States | Forest Investigative Site 015 | Orlando | Florida |
| United States | Forest Investigative Site 131 | Ormond Beach | Florida |
| United States | Forest Investigative Site 046 | Oxon Hill | Maryland |
| United States | Forest Investigative Site 033 | Pelzer | South Carolina |
| United States | Forest Investigative Site 127 | Pembroke Pines | Florida |
| United States | Forest Investigative Site 030 | Peoria | Illinois |
| United States | Forest Investigative Site 080 | Peoria | Arizona |
| United States | Forest Investigative Site 066 | Philadelphia | Pennsylvania |
| United States | Forest Investigative Site 098 | Phoenix | Arizona |
| United States | Forest Investigative Site 133 | Phoenix | Arizona |
| United States | Forest Investigative Site 068 | Renton | Washington |
| United States | Forest Investigative Site 031 | Riverside | California |
| United States | Forest Investigative Site 165 | Rockville | Maryland |
| United States | Forest Investigative Site 091 | Roseville | California |
| United States | Forest Investigative Site 084 | Roswell | Georgia |
| United States | Forest Investigative Site 132 | Roswell | Georgia |
| United States | Forest Investigative Site 067 | Sacramento | California |
| United States | Forest Investigative Site 140 | Sacramento | California |
| United States | Forest Investigative Site 040 | Salisbury | North Carolina |
| United States | Forest Investigative Site 076 | Salt Lake City | Utah |
| United States | Forest Investigative Site 109 | San Antonio | Texas |
| United States | Forest Investigative Site 119 | San Antonio | Texas |
| United States | Forest Investigative Site 146 | San Antonio | Texas |
| United States | Forest Investigative Site 145 | San Mateo | California |
| United States | Forest Investigative Site 112 | Santa Ana | California |
| United States | Forest Investigative Site 018 | Sarasota | Florida |
| United States | Forest Investigative Site 044 | Scottsdale | Arizona |
| United States | Forest Investigative Site 092 | Spokane | Washington |
| United States | Forest Investigative Site 123 | Springfield | Illinois |
| United States | Forest Investigative Site 075 | St Petersburg | Florida |
| United States | Forest Investigative Site 029 | St. Clair Shores | Michigan |
| United States | Forest Investigative Site 142 | St. Louis | Missouri |
| United States | Forest Investigative Site 143 | St. Louis | Missouri |
| United States | Forest Investigative Site 138 | Tamarac | Florida |
| United States | Forest Investigative Site 036 | Tipton | Pennsylvania |
| United States | Forest Investigative Site 087 | Tucson | Arizona |
| United States | Forest Investigative Site 128 | Tustin | California |
| United States | Forest Investigative Site 028 | Virginia Beach | Virginia |
| United States | Forest Investigative Site 011 | Walnut Creek | California |
| United States | Forest Investigative Site 007 | Waltham | Massachusetts |
| United States | Forest Investigative Site 063 | West Hills | California |
| United States | Forest Investigative Site 026 | West Palm Beach | Florida |
| United States | Forest Investigative Site 008 | Wichita | Kansas |
| United States | Forest Investigative Site 082 | Winston-Salem | North Carolina |
| United States | Forest Investigative Site 153 | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories | Phenomix |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG | 52 weeks | Yes | |
| Secondary | To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose. | 52 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
| Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
| Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
Phase 4 | |
| Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
| Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
| Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
| Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
N/A | |
| Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
|
Phase 1 | |
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
| Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
N/A | |
| Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
|
||
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
Phase 4 | |
| Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |