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

NCT01089790 | Terminated Phase 3

• 1 other identifier: DUT-MD-403
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 149

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

  52 weeks

Secondary Outcomes (1)

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

  52 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: Dutogliptin

2

ACTIVE COMPARATOR

Drug: Sitagliptin

Interventions

Dutogliptin DRUG

400 mg tablet, once daily

Also known as: PHX1149

1

Sitagliptin DRUG

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

Also known as: Januvia

2

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead
• Phenomix: collaborator

Study Sites (149)

Forest Investigative Site 064

Birmingham, Alabama, 35205, United States

Location

Forest Investigative Site 020

Birmingham, Alabama, 35235, United States

Location

Forest Investigative Site 025

Muscle Shoals, Alabama, 35661, United States

Location

Forest Investigative Site 059

Chandler, Arizona, 85225, United States

Location

Forest Investigative Site 113

Gilbert, Arizona, 85295, United States

Location

Forest Investigative Site 096

Goodyear, Arizona, 85395, United States

Location

Forest Investigative Site 080

Peoria, Arizona, 85381, United States

Location

Forest Investigative Site 098

Phoenix, Arizona, 85020, United States

Location

Forest Investigative Site 133

Phoenix, Arizona, 85023, United States

Location

Forest Investigative Site 044

Scottsdale, Arizona, 85254, United States

Location

Forest Investigative Site 087

Tucson, Arizona, 85741, United States

Location

Forest Investigative Site 061

Anaheim, California, 92801, United States

Location

Forest Investigative Site 152

Anaheim, California, 92804, United States

Location

Forest Investigative Site 041

Chula Vista, California, 91911, United States

Location

Forest Investigative Site 049

Encinitas, California, 92024, United States

Location

Forest Investigative Site 022

Greenbrae, California, 94904, United States

Location

Forest Investigative Site 047

Harbor City, California, 90710, United States

Location

Forest Investigative Site 010

Huntington Park, California, 90255, United States

Location

Forest Investigative Site 070

Los Angeles, California, 90057, United States

Location

Forest Investigative Site 111

Northridge, California, 91325, United States

Location

Forest Investigative Site 031

Riverside, California, 92506, United States

Location

Forest Investigative Site 091

Roseville, California, 95661, United States

Location

Forest Investigative Site 140

Sacramento, California, 95816, United States

Location

Forest Investigative Site 067

Sacramento, California, 95821, United States

Location

Forest Investigative Site 145

San Mateo, California, 94401, United States

Location

Forest Investigative Site 112

Santa Ana, California, 92701, United States

Location

Forest Investigative Site 128

Tustin, California, 92780, United States

Location

Forest Investigative Site 011

Walnut Creek, California, 94598, United States

Location

Forest Investigative Site 063

West Hills, California, 91307, United States

Location

Forest Investigative Site 115

Colorado Springs, Colorado, 80910, United States

Location

Forest Investigative Site 088

Denver, Colorado, 80239, United States

Location

Forest Investigative Site 156

Boca Raton, Florida, 33432, United States

Location

Forest Investigative Site 148

Brandenton, Florida, 34205, United States

Location

Forest Investigative Site 073

Clearwater, Florida, 33765, United States

Location

Forest Investigative Site 004

Daytona Beach, Florida, 32117, United States

Location

Forest Investigative Site 052

DeLand, Florida, 32720, United States

Location

Forest Investigative Site 144

Hialeah, Florida, 33012, United States

Location

Forest Investigative Site 129

Hollywood, Florida, 33021, United States

Location

Forest Investigative Site 062

Jacksonville, Florida, 32205, United States

Location

Forest Investigative Site 161

Miami, Florida, 33136, United States

Location

Forest Investigative Site 157

Miami, Florida, 33143, United States

Location

Forest Investigative Site 154

Miami, Florida, 33175, United States

Location

Forest Investigative Site 050

Miami, Florida, 33183, United States

Location

Forest Investigative Site 122

Miami, Florida, 33186, United States

Location

Forest Investigative Site 125

Miami Lakes, Florida, 33014, United States

Location

Forest Investigative Site 069

New Port Richey, Florida, 34652, United States

Location

Forest Investigative Site 012

Ocala, Florida, 34471, United States

Location

Forest Investigative Site 015

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 131

Ormond Beach, Florida, 32174, United States

Location

Forest Investigative Site 127

Pembroke Pines, Florida, 33028, United States

Location

Forest Investigative Site 018

Sarasota, Florida, 34239, United States

Location

Forest Investigative Site 075

St. Petersburg, Florida, 33716, United States

Location

Forest Investigative Site 138

Tamarac, Florida, 33319, United States

Location

Forest Investigative Site 026

West Palm Beach, Florida, 33401, United States

Location

Forest Investigative Site 045

Atlanta, Georgia, 30338, United States

Location

Forest Investigative Site 079

Augusta, Georgia, 30909, United States

Location

Forest Investigative Site 077

Decatur, Georgia, 30035, United States

Location

Forest Investigative Site 042

Dunwoody, Georgia, 30338, United States

Location

Forest Investigative Site 084

Roswell, Georgia, 30076, United States

Location

Forest Investigative Site 132

Roswell, Georgia, 30076, United States

Location

Forest Investigative Site 009

Meridian, Idaho, 83646, United States

Location

Forest Investigative Site 030

Peoria, Illinois, 61614, United States

Location

Forest Investigative Site 123

Springfield, Illinois, 62704, United States

Location

Forest Investigative Site 100

Evansville, Indiana, 47710, United States

Location

Forest Investigative Site 097

Evansville, Indiana, 47713, United States

Location

Forest Investigative Site 053

Kansas City, Kansas, 66160, United States

Location

Forest Investigative Site 008

Wichita, Kansas, 67203, United States

Location

Forest Investigative Site 078

Erlanger, Kentucky, 41018, United States

Location

Forest Investigative Site 107

Lexington, Kentucky, 40504, United States

Location

Forest Investigative Site 024

Madisonville, Kentucky, 42431, United States

Location

Forest Investigative Site 034

Covington, Louisiana, 70433, United States

Location

Forest Investigative Site 035

Baltimore, Maryland, 21204, United States

Location

Forest Investigative Site 046

Oxon Hill, Maryland, 20745, United States

Location

Forest Investigative Site 165

Rockville, Maryland, 20852, United States

Location

Forest Investigative Site 003

Brockton, Massachusetts, 02301, United States

Location

Forest Investigative Site 055

Brockton, Massachusetts, 02301, United States

Location

Forest Investigative Site 118

New Bedford, Massachusetts, 02740, United States

Location

Forest Investigative Site 007

Waltham, Massachusetts, 02453, United States

Location

Forest Investigative Site 163

Cadillac, Michigan, 49601, United States

Location

Forest Investigative Site 002

Dearborn, Michigan, 48126, United States

Location

Forest Investigative Site 029

Saint Clair Shores, Michigan, 48081, United States

Location

Forest Investigative Site 054

Edina, Minnesota, 55435, United States

Location

Forest Investigative Site 142

St Louis, Missouri, 63110, United States

Location

Forest Investigative Site 143

St Louis, Missouri, 63110, United States

Location

Forest Investigative Site 013

Grand Island, Nebraska, 68803, United States

Location

Forest Investigative Site 150

Omaha, Nebraska, 68114, United States

Location

Forest Investigative Site 072

Las Vegas, Nevada, 89101, United States

Location

Forest Investigative Site 065

Las Vegas, Nevada, 89117, United States

Location

Forest Investigative Site 147

Berkeley Heights, New Jersey, 07922, United States

Location

Forest Investigative Site 137

Albuquerque, New Mexico, 87102, United States

Location

Forest Investigative Site 101

Albuquerque, New Mexico, 87108, United States

Location

Forest Investigative Site 006

Albany, New York, 12206, United States

Location

Forest Investigative Site 081

New Hyde Park, New York, 11042, United States

Location

Forest Investigative Site 016

New York, New York, 10019, United States

Location

Forest Investigative Site 151

New York, New York, 10032, United States

Location

Forest Investigative Site 155

Asheboro, North Carolina, 27203, United States

Location

Forest Investigative Site 094

Charlotte, North Carolina, 28204, United States

Location

Forest Investigative Site 051

Charlotte, North Carolina, 28209, United States

Location

Forest Investigative Site 117

Charlotte, North Carolina, 28277, United States

Location

Forest Investigative Site 135

Durham, North Carolina, 27704, United States

Location

Forest Investigative Site 058

Lenoir, North Carolina, 28645, United States

Location

Forest Investigative Site 038

Morehead City, North Carolina, 28557, United States

Location

Forest Investigative Site 040

Salisbury, North Carolina, 28144, United States

Location

Forest Investigative Site 082

Winston-Salem, North Carolina, 27103, United States

Location

Forest Investigative Site 039

Akron, Ohio, 44311, United States

Location

Forest Investigative Site 023

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 043

Columbus, Ohio, 43201, United States

Location

Forest Investigative Site 057

Dayton, Ohio, 45406, United States

Location

Forest Investigative Site 032

Kettering, Ohio, 45429, United States

Location

Forest Investigative Site 141

Marion, Ohio, 43302, United States

Location

Forest Investigative Site 159

Marion, Ohio, 43302, United States

Location

Forest Investigative Site 153

Zanesville, Ohio, 43701, United States

Location

Forest Investigative Site 083

Bethany, Oklahoma, 73008, United States

Location

Forest Investigative Site 149

Norman, Oklahoma, 73069, United States

Location

Forest Investigative Site 102

Ashland, Oregon, 97520, United States

Location

Forest Investigative Site 005

Eugene, Oregon, 97404, United States

Location

Forest Investigative Site 001

Medford, Oregon, 97504, United States

Location

Forest Investigative Site 130

Bensalem, Pennsylvania, 19020, United States

Location

Forest Investigative Site 037

Harleysville, Pennsylvania, 19438, United States

Location

Forest Investigative Site 126

Jenkintown, Pennsylvania, 19046, United States

Location

Forest Investigative Site 158

Morrisville, Pennsylvania, 19067, United States

Location

Forest Investigative Site 066

Philadelphia, Pennsylvania, 19152, United States

Location

Forest Investigative Site 036

Tipton, Pennsylvania, 16684, United States

Location

Forest Investigative Site 103

Greer, South Carolina, 29651, United States

Location

Forest Investigative Site 090

Manning, South Carolina, 29102, United States

Location

Forest Investigative Site 033

Pelzer, South Carolina, 29669, United States

Location

Forest Investigative Site 048

Bristol, Tennessee, 37620, United States

Location

Forest Investigative Site 114

Chattanooga, Tennessee, 37404, United States

Location

Forest Investigative Site 104

Chattanooga, Tennessee, 37421, United States

Location

Forest Investigative Site 099

Arlington, Texas, 76014, United States

Location

Forest Investigative Site 056

Corpus Christi, Texas, 78404, United States

Location

Forest Investigative Site 071

Dallas, Texas, 75230, United States

Location

Forest Investigative Site 017

Dallas, Texas, 75235, United States

Location

Forest Investigative Site 124

Dallas, Texas, 75251, United States

Location

Forest Investigative Site 162

DeSoto, Texas, 75115, United States

Location

Forest Investigative Site 136

Houston, Texas, 77002, United States

Location

Forest Investigative Site 106

Houston, Texas, 77079, United States

Location

Forest Investigative Site 014

Irving, Texas, 75039, United States

Location

Forest Investigative Site 139

Irving, Texas, 75039, United States

Location

Forest Investigative Site 160

New Braunfels, Texas, 78130, United States

Location

Forest Investigative Site 146

San Antonio, Texas, 78205, United States

Location

Forest Investigative Site 109

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 119

San Antonio, Texas, 78258, United States

Location

Forest Investigative Site 076

Salt Lake City, Utah, 84107, United States

Location

Forest Investigative Site 121

Arlington, Virginia, 22204, United States

Location

Forest Investigative Site 028

Virginia Beach, Virginia, 23454, United States

Location

Forest Investigative Site 068

Renton, Washington, 98057, United States

Location

Forest Investigative Site 092

Spokane, Washington, 99207, United States

Location

Forest Investigative Site 027

Milwaukee, Wisconsin, 53209, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dutogliptin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Kaity Posada, PharmD

  Forest Research Institute, a subsidiary of Forest Laboratories Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 19, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

US (149)