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Diabetes Mellitus, Type 2Phase 3REDWOOD403NCT01089790

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

A Phase 3 study testing Dutogliptin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Forest Laboratories at 149 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM). Read more about this study

Who is it for?
Ages 18 to 86 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Dutogliptin and Sitagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
149 sitesUnited States
Study dates
Mar 2010to Aug 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

149 sites in 1 country.

149 sites in 1 country

United States149 sites

  • Forest Investigative Site 039

    Akron, Ohio, 44311

  • Forest Investigative Site 006

    Albany, New York, 12206

  • Forest Investigative Site 137

    Albuquerque, New Mexico, 87102

  • Forest Investigative Site 101

    Albuquerque, New Mexico, 87108

  • Forest Investigative Site 061

    Anaheim, California, 92801

  • Forest Investigative Site 152

    Anaheim, California, 92804

  • Forest Investigative Site 099

    Arlington, Texas, 76014

  • Forest Investigative Site 121

    Arlington, Virginia, 22204

  • Forest Investigative Site 155

    Asheboro, North Carolina, 27203

  • Forest Investigative Site 102

    Ashland, Oregon, 97520

  • Forest Investigative Site 045

    Atlanta, Georgia, 30338

  • Forest Investigative Site 079

    Augusta, Georgia, 30909

  • Forest Investigative Site 035

    Baltimore, Maryland, 21204

  • Forest Investigative Site 130

    Bensalem, Pennsylvania, 19020

  • Forest Investigative Site 147

    Berkeley Heights, New Jersey, 07922

  • Forest Investigative Site 083

    Bethany, Oklahoma, 73008

  • Forest Investigative Site 064

    Birmingham, Alabama, 35205

  • Forest Investigative Site 020

    Birmingham, Alabama, 35235

  • Forest Investigative Site 156

    Boca Raton, Florida, 33432

  • Forest Investigative Site 148

    Brandenton, Florida, 34205

  • Forest Investigative Site 048

    Bristol, Tennessee, 37620

  • Forest Investigative Site 003

    Brockton, Massachusetts, 02301

  • Forest Investigative Site 055

    Brockton, Massachusetts, 02301

  • Forest Investigative Site 163

    Cadillac, Michigan, 49601

  • Forest Investigative Site 059

    Chandler, Arizona, 85225

  • Forest Investigative Site 094

    Charlotte, North Carolina, 28204

  • Forest Investigative Site 051

    Charlotte, North Carolina, 28209

  • Forest Investigative Site 117

    Charlotte, North Carolina, 28277

  • Forest Investigative Site 114

    Chattanooga, Tennessee, 37404

  • Forest Investigative Site 104

    Chattanooga, Tennessee, 37421

  • Forest Investigative Site 041

    Chula Vista, California, 91911

  • Forest Investigative Site 023

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 073

    Clearwater, Florida, 33765

  • Forest Investigative Site 115

    Colorado Springs, Colorado, 80910

  • Forest Investigative Site 043

    Columbus, Ohio, 43201

  • Forest Investigative Site 056

    Corpus Christi, Texas, 78404

  • Forest Investigative Site 034

    Covington, Louisiana, 70433

  • Forest Investigative Site 071

    Dallas, Texas, 75230

  • Forest Investigative Site 017

    Dallas, Texas, 75235

  • Forest Investigative Site 124

    Dallas, Texas, 75251

  • Forest Investigative Site 057

    Dayton, Ohio, 45406

  • Forest Investigative Site 004

    Daytona Beach, Florida, 32117

  • Forest Investigative Site 002

    Dearborn, Michigan, 48126

  • Forest Investigative Site 077

    Decatur, Georgia, 30035

  • Forest Investigative Site 052

    DeLand, Florida, 32720

  • Forest Investigative Site 088

    Denver, Colorado, 80239

  • Forest Investigative Site 162

    DeSoto, Texas, 75115

  • Forest Investigative Site 042

    Dunwoody, Georgia, 30338

  • Forest Investigative Site 135

    Durham, North Carolina, 27704

  • Forest Investigative Site 054

    Edina, Minnesota, 55435

  • Forest Investigative Site 049

    Encinitas, California, 92024

  • Forest Investigative Site 078

    Erlanger, Kentucky, 41018

  • Forest Investigative Site 005

    Eugene, Oregon, 97404

  • Forest Investigative Site 100

    Evansville, Indiana, 47710

  • Forest Investigative Site 097

    Evansville, Indiana, 47713

  • Forest Investigative Site 113

    Gilbert, Arizona, 85295

  • Forest Investigative Site 096

    Goodyear, Arizona, 85395

  • Forest Investigative Site 013

    Grand Island, Nebraska, 68803

  • Forest Investigative Site 022

    Greenbrae, California, 94904

  • Forest Investigative Site 103

    Greer, South Carolina, 29651

  • Forest Investigative Site 047

    Harbor City, California, 90710

  • Forest Investigative Site 037

    Harleysville, Pennsylvania, 19438

  • Forest Investigative Site 144

    Hialeah, Florida, 33012

  • Forest Investigative Site 129

    Hollywood, Florida, 33021

  • Forest Investigative Site 136

    Houston, Texas, 77002

  • Forest Investigative Site 106

    Houston, Texas, 77079

  • Forest Investigative Site 010

    Huntington Park, California, 90255

  • Forest Investigative Site 014

    Irving, Texas, 75039

  • Forest Investigative Site 139

    Irving, Texas, 75039

  • Forest Investigative Site 062

    Jacksonville, Florida, 32205

  • Forest Investigative Site 126

    Jenkintown, Pennsylvania, 19046

  • Forest Investigative Site 053

    Kansas City, Kansas, 66160

  • Forest Investigative Site 032

    Kettering, Ohio, 45429

  • Forest Investigative Site 072

    Las Vegas, Nevada, 89101

  • Forest Investigative Site 065

    Las Vegas, Nevada, 89117

  • Forest Investigative Site 058

    Lenoir, North Carolina, 28645

  • Forest Investigative Site 107

    Lexington, Kentucky, 40504

  • Forest Investigative Site 070

    Los Angeles, California, 90057

  • Forest Investigative Site 024

    Madisonville, Kentucky, 42431

  • Forest Investigative Site 090

    Manning, South Carolina, 29102

  • Forest Investigative Site 141

    Marion, Ohio, 43302

  • Forest Investigative Site 159

    Marion, Ohio, 43302

  • Forest Investigative Site 001

    Medford, Oregon, 97504

  • Forest Investigative Site 009

    Meridian, Idaho, 83646

  • Forest Investigative Site 161

    Miami, Florida, 33136

  • Forest Investigative Site 157

    Miami, Florida, 33143

  • Forest Investigative Site 154

    Miami, Florida, 33175

  • Forest Investigative Site 050

    Miami, Florida, 33183

  • Forest Investigative Site 122

    Miami, Florida, 33186

  • Forest Investigative Site 125

    Miami Lakes, Florida, 33014

  • Forest Investigative Site 027

    Milwaukee, Wisconsin, 53209

  • Forest Investigative Site 038

    Morehead City, North Carolina, 28557

  • Forest Investigative Site 158

    Morrisville, Pennsylvania, 19067

  • Forest Investigative Site 025

    Muscle Shoals, Alabama, 35661

  • Forest Investigative Site 118

    New Bedford, Massachusetts, 02740

  • Forest Investigative Site 160

    New Braunfels, Texas, 78130

  • Forest Investigative Site 081

    New Hyde Park, New York, 11042

  • Forest Investigative Site 069

    New Port Richey, Florida, 34652

  • Forest Investigative Site 016

    New York, New York, 10019

  • Forest Investigative Site 151

    New York, New York, 10032

  • Forest Investigative Site 149

    Norman, Oklahoma, 73069

  • Forest Investigative Site 111

    Northridge, California, 91325

  • Forest Investigative Site 012

    Ocala, Florida, 34471

  • Forest Investigative Site 150

    Omaha, Nebraska, 68114

  • Forest Investigative Site 015

    Orlando, Florida, 32806

  • Forest Investigative Site 131

    Ormond Beach, Florida, 32174

  • Forest Investigative Site 046

    Oxon Hill, Maryland, 20745

  • Forest Investigative Site 033

    Pelzer, South Carolina, 29669

  • Forest Investigative Site 127

    Pembroke Pines, Florida, 33028

  • Forest Investigative Site 080

    Peoria, Arizona, 85381

  • Forest Investigative Site 030

    Peoria, Illinois, 61614

  • Forest Investigative Site 066

    Philadelphia, Pennsylvania, 19152

  • Forest Investigative Site 098

    Phoenix, Arizona, 85020

  • Forest Investigative Site 133

    Phoenix, Arizona, 85023

  • Forest Investigative Site 068

    Renton, Washington, 98057

  • Forest Investigative Site 031

    Riverside, California, 92506

  • Forest Investigative Site 165

    Rockville, Maryland, 20852

  • Forest Investigative Site 091

    Roseville, California, 95661

  • Forest Investigative Site 084

    Roswell, Georgia, 30076

  • Forest Investigative Site 132

    Roswell, Georgia, 30076

  • Forest Investigative Site 140

    Sacramento, California, 95816

  • Forest Investigative Site 067

    Sacramento, California, 95821

  • Forest Investigative Site 029

    Saint Clair Shores, Michigan, 48081

  • Forest Investigative Site 040

    Salisbury, North Carolina, 28144

  • Forest Investigative Site 076

    Salt Lake City, Utah, 84107

  • Forest Investigative Site 146

    San Antonio, Texas, 78205

  • Forest Investigative Site 109

    San Antonio, Texas, 78229

  • Forest Investigative Site 119

    San Antonio, Texas, 78258

  • Forest Investigative Site 145

    San Mateo, California, 94401

  • Forest Investigative Site 112

    Santa Ana, California, 92701

  • Forest Investigative Site 018

    Sarasota, Florida, 34239

  • Forest Investigative Site 044

    Scottsdale, Arizona, 85254

  • Forest Investigative Site 092

    Spokane, Washington, 99207

  • Forest Investigative Site 123

    Springfield, Illinois, 62704

  • Forest Investigative Site 142

    St Louis, Missouri, 63110

  • Forest Investigative Site 143

    St Louis, Missouri, 63110

  • Forest Investigative Site 075

    St. Petersburg, Florida, 33716

  • Forest Investigative Site 138

    Tamarac, Florida, 33319

  • Forest Investigative Site 036

    Tipton, Pennsylvania, 16684

  • Forest Investigative Site 087

    Tucson, Arizona, 85741

  • Forest Investigative Site 128

    Tustin, California, 92780

  • Forest Investigative Site 028

    Virginia Beach, Virginia, 23454

  • Forest Investigative Site 011

    Walnut Creek, California, 94598

  • Forest Investigative Site 007

    Waltham, Massachusetts, 02453

  • Forest Investigative Site 063

    West Hills, California, 91307

  • Forest Investigative Site 026

    West Palm Beach, Florida, 33401

  • Forest Investigative Site 008

    Wichita, Kansas, 67203

  • Forest Investigative Site 082

    Winston-Salem, North Carolina, 27103

  • Forest Investigative Site 153

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official 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

This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).

Being tested
Dutogliptin, Sitagliptin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DutogliptinDrug

    Also called PHX1149

    400 mg tablet, once daily

  • SitagliptinDrug

    Also called Januvia

    100 mg capsule (each capsule contains two 50-mg tablets), once daily

Study groups in NCT01089790
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Dutogliptin
2Active comparatorNot described
Receives: Drug: Sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG

    Measured: 52 weeks

Secondary outcomes (1)

  1. To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01089790
Sponsor's protocol ID
DUT-MD-403
Acronym
REDWOOD403
Status last verified
Sep 2011
First submitted
17 Mar 2010
Last updated
21 Sep 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dutogliptin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Forest Laboratories at 149 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01089790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2011.

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