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Diabetes Mellitus, Type IIPhase 3NCT00970424

Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

A Phase 3 study testing Dutogliptin in people with Diabetes Mellitus, Type II, run by Forest Laboratories at 118 sites in 6 countries.

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 safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Diabetes Mellitus, Type II
What is being tested?
Dutogliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
118 sitesin 6 countries
Study dates
Aug 2009to 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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
  • BMI 20 to 48 kg/m2, inclusive
  • HbA1c 7.0% - 10.0%, inclusive
  • Age 18 to 85 years, inclusive

Who cannot join

  • Currently taking more than one oral hypoglycemic agent
  • Type 1 diabetes mellitus

Trial locations and contacts

118 sites in 6 countries.

118 sites in 6 countries

United States89 sites

  • Forest Investigative Site 039

    Akron, Ohio, 44311

  • Forest Investigative Site 061

    Anaheim, California, 92801

  • Forest Investigative Site 099

    Arlington, Texas, 76014

  • 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 064

    Birmingham, Alabama, 35205

  • Forest Investigative Site 020

    Birmingham, Alabama, 35235

  • 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 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 052

    DeLand, Florida, 32720

  • 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 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 106

    Houston, Texas, 77079

  • Forest Investigative Site 010

    Huntington Park, California, 90255

  • Forest Investigative Site 014

    Irving, Texas, 75039

  • Forest Investigative Site 062

    Jacksonville, Florida, 32205

  • 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 096

    Litchfield, Arizona, 85340

  • Forest Investigative Site 024

    Madisonville, Kentucky, 42431

  • Forest Investigative Site 090

    Manning, South Carolina, 29102

  • Forest Investigative Site 60

    Melrose Park, Illinois, 60160

  • Forest Investigative Site 009

    Meridian, Idaho, 83646

  • Forest Investigative Site 021

    Miami, Florida, 33169

  • Forest Investigative Site 050

    Miami, Florida, 33183

  • Forest Investigative Site 122

    Miami, Florida, 33186

  • Forest Investigative Site 027

    Milwaukee, Wisconsin, 53209

  • Forest Investigative Site 038

    Morehead City, North Carolina, 28557

  • Forest Investigative Site 118

    New Bedford, Massachusetts, 02740

  • Forest Investigative Site 081

    New Hyde Park, New York, 11042

  • Forest Investigative Site 016

    New York, New York, 10019

  • Forest Investigative Site 149

    Norman, Oklahoma, 73069

  • Forest Investigative Site 111

    Northridge, California, 91325

  • Forest Investigative Site 015

    Orlando, Florida, 32806

  • Forest Investigative Site 046

    Oxon Hill, Maryland, 20745

  • Forest Investigative Site 033

    Pelzer, South Carolina, 29669

  • Forest Investigative Site 030

    Peoria, Illinois, 61614

  • Forest Investigative Site 066

    Philadelphia, Pennsylvania, 19152

  • Forest Investigative Site 098

    Phoenix, Arizona, 85020

  • Forest Investigative Site 031

    Riverside, California, 92506

  • Forest Investigative Site 091

    Roseville, California, 95661

  • 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 109

    San Antonio, Texas, 78229

  • 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 075

    St. Petersburg, Florida, 33716

  • Forest Investigative Site 036

    Tipton, Pennsylvania, 16684

  • Forest Investigative Site 087

    Tucson, Arizona, 85741

  • 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

Other trials in United States

India14 sites

  • Forest Investigative Site 618

    Ahmedabad, Gujarat, 380015

  • Forest Investigative Site 607

    Bangalore, Karnataka, 560003

  • Forest Investigative Site 606

    Bangalore, Karnataka, 560010

  • Forest Investigative Site 602

    Bangalore, Karnataka, 560043

  • Forest Investigative Site 604

    Bangalore, Karnataka, 560092

  • Forest Investigative Site 603

    Channi, Tamil Nadu, 600020

  • Forest Investigative Site 613

    Chennai, Tamil Nadu, 600013

  • Forest Investigative Site 620

    Haryāna, Karnal, 132001

  • Forest Investigative Site 601

    Mangalore, Karnataka, 575003

  • Forest Investigative Site 616

    Nagpur, Maharashtra, 440012

  • Forest Investigative Site 617

    Nashik, Maharashtra, 380015

  • Forest Investigative Site 612

    Pune, Maharashtra, 411037

  • Forest Investigative Site 615

    Vellore, Tamil Nadu, 632009

  • Forest Investigative Site 614

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

Romania7 sites

  • Forest Investigative Site 909

    Bacau, Romania, 600164

  • Forest Investigative Site 906

    Bucharest, Romania, 010584

  • Forest Investigative Site 908

    Bucharest, Romania, 020725

  • Forest Investigative Site 903

    Satu Mare, Romania, 440055

  • Forest Investigative Site 901

    Sibiu, Romania, 550245

  • Forest Investigative Site 905 Romania

    Tg Mures, Romania, 540142

  • Forest Investigative Site 902

    Timișoara, Romania, 300736

Other trials in Romania

Lithuania4 sites

  • Forest Investigative Site 702

    Kaunas, Lithunia, 48259

  • Forest Investigative Site 703

    Kaunas, Lithunia, 49456

  • Forest Investigative Site 704

    Klaipėda, Lithunia, 92288

  • Forest Investigative Site 705

    Vilnius, Lithunia, 09112

Other trials in Lithuania

Germany3 sites

  • Forest Investigative Site 401

    Dresden, Germany, 01099

  • Forest Investigative Site 402

    Dresden, Germany, 01307

  • Forest Investigative Site 403

    Mainz, Germany, 55116

Other trials in Germany

Belarus1 site

  • Forest Investigative Site 209

    Mogilev, Belarus, 212030

Other trials in Belarus

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.

Being tested
Placebo, Dutogliptin
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.

  • PlaceboDrug

    placebo, oral tablet administered once daily on background of pioglitazone

  • DutogliptinDrug

    dutogliptin, oral tablet administered once daily on background of pioglitazone

Study groups in NCT00970424
Study groupRoleWhat they receive
1Placebo comparatorplacebo, oral tablet administered once daily on background of pioglitazone
Receives: Drug: Placebo
2Experimentaldutogliptin, oral tablet administered once daily on background of pioglitazone
Receives: Drug: Dutogliptin

What is being measured

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

  1. Hemoglobin A1c Level (HbA1c)

    Measured: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)

Secondary outcomes (1)

  1. Fasting Plasma Glucose Level (FPG)

    Measured: FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).

Timeline

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

  1. First posted2 Sep 2009 (estimated)
  2. Study startAug 2009
  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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00970424
Sponsor's protocol ID
DUT-MD-304
Status last verified
Sep 2011
First submitted
1 Sep 2009
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 in people with Diabetes Mellitus, Type II, run by Forest Laboratories at 118 sites in 6 countries.

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 4 inclusion and 2 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 118 sites in United States, India, Romania, Lithuania, Germany and 1 more country. 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. Some participants in this study may receive a placebo. 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?

Hemoglobin A1c Level (HbA1c) (time frame: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)). 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 NCT00970424.

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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