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Type 2 DiabetesPhase 2NCT00698230

Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

A Phase 2 study testing INCB013739 and Metformin in people with Type 2 Diabetes, run by Incyte Corporation at 68 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
INCB013739 and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
68 sitesin 2 countries
Study dates
May 2008to May 2009
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Established diagnosis of Type 2 Diabetes
  • Stable dose of metformin for more than 8 weeks

Who cannot join

  • Subjects with Addison's disease or Cushing's Syndrome
  • Type 1 diabetes mellitus or secondary forms of diabetes
  • Subjects with uncontrolled thyroid disease
  • History of renal impairment

Trial locations and contacts

68 sites in 2 countries.

68 sites in 2 countries

United States62 sites

  • Study site

    Altoona, Pennsylvania, 16601

  • Study site

    Artesia, California

  • Study site

    Austin, Texas, 78705

  • Study site

    Bangor, Maine, 04401

  • Study site

    Belleville, Illinois, 62220

  • Study site

    Birmingham, Alabama, 35242

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Burke, Virginia, 22015

  • Study site

    Calabasas, California, 91307

  • Study site

    Calabash, North Carolina, 95032

  • Study site

    Chiefland, Florida, 32626

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbia, Maryland, 21045

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dunwoody, Georgia, 30338

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Fresno, California, 93720

  • Study site

    Georgetown, Texas

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Hampton, Virginia, 23666

  • Study site

    Harleysville, Pennsylvania, 19438

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77004

  • Study site

    Houston, Texas, 77023

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77081

  • Study site

    Houston, Texas, 77090

  • Study site

    Jenkintown, Pennsylvania, 19046

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Las Vegas, Nevada, 89101

  • Study site

    Longwood, Florida, 32779

  • Study site

    Los Angeles, California, 90057

  • Study site

    Los Gatos, California, 95032

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami Beach, Florida, 33140

  • Study site

    Midland, Texas, 79705

  • Study site

    Milwaukee, Wisconsin, 53209

  • Study site

    Mooresville, North Carolina, 28117

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    New York, New York, 10016

  • Study site

    Norman, Oklahoma, 73071

  • Study site

    North Myrtle Beach, South Carolina, 29582

  • Study site

    North Richland Hills, Texas, 76180

  • Study site

    Norton, Ohio, 44614

  • Study site

    Ocala, Florida, 34471

  • Study site

    Orlando, Florida, 32806

  • Study site

    Rome, Georgia, 30165

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Santa Ana, California

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    Shawnee Mission, Kansas, 66216

  • Study site

    South Miami, Florida, 33143

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Springfield Gardens, New York, 11413

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Sterling Heights, Michigan, 48314

  • Study site

    Tampa, Florida, 33614

  • Study site

    Temple, Texas, 76502

  • Study site

    Waco, Texas, 76710

  • Study site

    West Seneca, New York, 14224

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico6 sites

  • Study site

    Carolina, 00983

  • Study site

    Fajardo, 00738

  • Study site

    Ponce, 00716

  • Study site

    Rio Grande, 00745

  • Study site

    San Juan, 00909-1711

  • Study site

    San Juan, 00926-2832

Other trials in Puerto Rico

About this study

Official title: Randomized Study to Evaluate the Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetic Subjects

Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.

Conditions
Type 2 Diabetes
Being tested
INCB013739, Placebo comparator matching INCB013739, Metformin
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.

  • INCB013739Drug

    INCB013739 5 mg QD tablet

  • INCB013739Drug

    INCB013739 15 mg QD tablet

  • INCB013739Drug

    INCB013739 50 mg QD tablet

  • INCB013739Drug

    INCB013739 100 mg QD tablet

  • INCB013739Drug

    INCB013739 200 mg QD

  • Placebo comparator matching INCB013739Drug

    Orally once daily tablet

  • MetforminDrug

Study groups in NCT00698230
Study groupRoleWhat they receive
Treatment A - INCB013739 & MetforminExperimentalINCB013739 5 mg QD and Metformin
Receives: Drug: INCB013739; Drug: Metformin
Treatment B - INCB013739 & MetforminExperimentalINCB013739 15 mg QD and Metformin
Receives: Drug: INCB013739; Drug: Metformin
Treatment C - INCB013739 & MetforminExperimentalINCB013739 50 mg QD and Metformin
Receives: Drug: INCB013739; Drug: Metformin
Treatment D - INCB013739 & MetforminExperimentalINCB013739 100 mg QD and Metformin
Receives: Drug: INCB013739; Drug: Metformin
Treatment E - INCB013739 & MetforminExperimentalINCB013739 200 mg QD and Metformin
Receives: Drug: INCB013739; Drug: Metformin
Treatment F - PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo comparator matching INCB013739

What is being measured

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

  1. Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)

    Measured: Baseline and Week 12 (or early termination study visit)

Secondary outcomes (1)

  1. Change from Baseline to Week 12 in fasting plasma glucose (FPG).

    Measured: Baseline and Week 12 (or early termination study visit)

Timeline

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

  1. First posted17 Jun 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionApr 2009
  4. Study completionMay 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00698230
Sponsor's protocol ID
INCB 13739-202
Status last verified
Feb 2018
First submitted
13 Jun 2008
Last updated
14 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • Rosenstock J, Banarer S, Fonseca VA, Inzucchi SE, Sun W, Yao W, Hollis G, Flores R, Levy R, Williams WV, Seckl JR, Huber R; INCB13739-202 Principal Investigators. The 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor INCB13739 improves hyperglycemia in patients with type 2 diabetes inadequately controlled by metformin monotherapy. Diabetes Care. 2010 Jul;33(7):1516-22. doi: 10.2337/dc09-2315. Epub 2010 Apr 22.

    PubMed 20413513

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INCB013739 and Metformin in people with Type 2 Diabetes, run by Incyte Corporation at 68 sites in 2 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline to Week 12 in hemoglobin A1c (HbA1c) (time frame: Baseline and Week 12 (or early termination study visit)). 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 NCT00698230, which also lists 1 linked publication.

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 14 Feb 2018.

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