Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

NCT ID: NCT00850239

Last Updated: 2010-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

dutogliptin/PHX1149T

Group Type EXPERIMENTAL

dutogliptin

Intervention Type DRUG

400 mg

2

Plabeco

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dutogliptin

400 mg

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PHX1149T

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
* Age 18 to 85 years, inclusive.
* Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
* Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
* HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (\> 0.8 ng/mL; \> 281 pmol/L) at screening (Visit 1)

Exclusion Criteria

* Type 1 diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Phenomix

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Phenomix Corporation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phenomix Investigational Site 115

Montgomery, Alabama, United States

Site Status

Phenomix Investigational Site 121

Tempe, Arizona, United States

Site Status

Phenomix Investigational Site 137

Tempe, Arizona, United States

Site Status

Phenomix Investigational Site 105

Anaheim, California, United States

Site Status

Phenomix Investigational Site 123

Chico, California, United States

Site Status

Phenomix Investigational Site 134

Escondido, California, United States

Site Status

Phenomix Investigational Site 103

Long Beach, California, United States

Site Status

Phenomix Investigational Site 106

Los Angeles, California, United States

Site Status

Phenomix Investigational Site 143

Coral Gables, Florida, United States

Site Status

Phenomix Investigational Site 142

Hialeah, Florida, United States

Site Status

Phenomix Investigational Site 119

Jacksonville, Florida, United States

Site Status

Phenomix Investigational Site 133

Kissimmee, Florida, United States

Site Status

Phenomix Investigational Site 141

Dunwoody, Georgia, United States

Site Status

Phenomix Investigational Site 101

Honolulu, Hawaii, United States

Site Status

Phenomix Investigational Site 135

Chicago, Illinois, United States

Site Status

Phenomix Investigational Site 124

Indianapolis, Indiana, United States

Site Status

Phenomix Investigational Site 127

Indianapolis, Indiana, United States

Site Status

Phenomix Investigational Site 136

Brockton, Massachusetts, United States

Site Status

Phenomix Investigational Site 125

Kalamazoo, Michigan, United States

Site Status

Phenomix Investigational Site 138

Biloxi, Mississippi, United States

Site Status

Phenomix Investigational Site 122

Las Vegas, Nevada, United States

Site Status

Phenomix Investigational Site 140

Las Vegas, Nevada, United States

Site Status

Phenomix Investigational Site 131

Brick, New Jersey, United States

Site Status

Phenomix Investigational Site 110

Trenton, New Jersey, United States

Site Status

Phenomix Investigational Site 116

Albuquerque, New Mexico, United States

Site Status

Phenomix Investigational Site 107

Winston-Salem, North Carolina, United States

Site Status

Phenomix Investigational Site 130

Cincinnati, Ohio, United States

Site Status

Phenomix Investigational Site 118

Cuyahoga Falls, Ohio, United States

Site Status

Phenomix Investigational Site 112

Greenville, South Carolina, United States

Site Status

Phenomix Investigational Site 102

Dallas, Texas, United States

Site Status

Phenomix Investigational Site 139

Dallas, Texas, United States

Site Status

Phenomix Investigational Site 126

El Paso, Texas, United States

Site Status

Phenomix Investigational Site 104

San Antonio, Texas, United States

Site Status

Phenomix Investigational Site 100

Kenosha, Wisconsin, United States

Site Status

Phenomix Investigational Site 401

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 402

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 404

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 405

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 406

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 407

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 408

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 409

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 411

Buenos Aires, , Argentina

Site Status

Phenomix Investigational Site 403

Corrientes, , Argentina

Site Status

Phenomix Investigational Site 410

Mendoza, , Argentina

Site Status

Phenomix Investigational Site 400

Rosario, , Argentina

Site Status

Phenomix Investigational Site 502

Santiago, , Chile

Site Status

Phenomix Investigational Site 504

Santiago, , Chile

Site Status

Phenomix Investigational Site 505

Santiago, , Chile

Site Status

Phenomix Investigational Site 500

Temuco, , Chile

Site Status

Phenomix Investigational Site 501

Temuco, , Chile

Site Status

Phenomix Investigational Site 209

Chodov, , Czechia

Site Status

Phenomix Investigational Site 205

Havířov-Město, , Czechia

Site Status

Phenomix Investigational Site 204

Liberec, , Czechia

Site Status

Phenomix Investigational Site 202

Olomouc, , Czechia

Site Status

Phenomix Investigational Site 206

Ostrava-Kunčice, , Czechia

Site Status

Phenomix Investigational Site 208

Prague, , Czechia

Site Status

Phenomix Investigational Site 203

Prostějov, , Czechia

Site Status

Phenomix Investigational Site 207

Uničov, , Czechia

Site Status

Phenomix Investigational Site 201

Valašské Klobouky, , Czechia

Site Status

Phenomix Investigational Site 703

Hyderabad, Andhara Pradesh, India

Site Status

Phenomix Investigational Site 704

Visakhapatanam, Andhra Pradesh, India

Site Status

Phenomix Investigational Site 709

Gopālapuram, Chennai, India

Site Status

Phenomix Investigational Site 707

Shāstrinagar, Jaipur, India

Site Status

Phenomix Investigational Site 701

Bangalore, Karnataka, India

Site Status

Phenomix Investigational Site 702

Bangalore, Karnataka, India

Site Status

Phenomix Investigational Site 705

Trivandrum, Kerala, India

Site Status

Phenomix Investigational Site 706

Indore, Madhya Pradesh, India

Site Status

Phenomix Investigational Site 711

Mumbai, Maharashtra, India

Site Status

Phenomix Investigational Site 700

Nashik, Maharashtra, India

Site Status

Phenomix Investigational Site 710

Navi Mumbai, Maharashtra, India

Site Status

Phenomix Investigational Site 708

Chennai, , India

Site Status

Phenomix Investigational Site 607

Arequipa, , Peru

Site Status

Phenomix Investigational Site 601

Ica, , Peru

Site Status

Phenomix Investigational Site 600

Lima, , Peru

Site Status

Phenomix Investigational Site 603

Lima, , Peru

Site Status

Phenomix Investigational Site 604

Lima, , Peru

Site Status

Phenomix Investigational Site 608

Lima, , Peru

Site Status

Phenomix Investigational Site 610

Lima, , Peru

Site Status

Phenomix Investigational Site 605

Lima Cercado, , Peru

Site Status

Phenomix Investigational Site 606

Piura, , Peru

Site Status

Phenomix Investigational Site 602

Trujillo, , Peru

Site Status

Phenomix Investigational Site 609

Wanchaq Cusco, , Peru

Site Status

Phenomix Investigational Site 300

Gdansk, , Poland

Site Status

Phenomix Investigational Site 301

Gdansk, , Poland

Site Status

Phenomix Investigational Site 303

Katowice, , Poland

Site Status

Phenomix Investigational Site 312

Katowice, , Poland

Site Status

Phenomix Investigational Site 309

Krakow, , Poland

Site Status

Phenomix Investigational Site 313

Krakow, , Poland

Site Status

Phenomix Investigational Site 308

Lublin, , Poland

Site Status

Phenomix Investigational Site 310

Poznan, , Poland

Site Status

Phenomix Investigational Site 306

Puławy, , Poland

Site Status

Phenomix Investigational Site 304

Szczecin, , Poland

Site Status

Phenomix Investigational Site 305

Warsaw, , Poland

Site Status

Phenomix Investigational Site 307

Warsaw, , Poland

Site Status

Phenomix Investigational Site 311

Warsaw, , Poland

Site Status

Phenomix Investigational Site 302

Wroclaw, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Chile Czechia India Peru Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHX1149-PROT302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.