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Type 2 Diabetes MellitusPhase 3NCT00885378

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

A Phase 3 study testing Saxagliptin plus metformin IR in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 41 sites in 4 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

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone. Read more about this study

Who is it for?
Ages 18 to 78 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Saxagliptin plus metformin IR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
166 participants
Where
41 sitesin 4 countries
Study dates
May 2009to Feb 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 78 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes
  • 18-78 years of age
  • Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
  • A1C: 7-10%
  • C-peptide: ≥ 0.8 ng/mL
  • Body mass index (BMI): ≤45 kg/m^2

Who cannot join

  • Women of childbearing potential unable or unwilling to use acceptable birth control
  • Women who are pregnant or breastfeeding
  • Fasting plasma glucose (FPG) >270 mg/dL
  • Significant cardiovascular history
  • Symptoms of poorly controlled diabetes
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
Show all 14Show fewer
  • Insulin therapy within one year of screening
  • Cardiovascular even within the prior 6 months
  • New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction <=40%
  • Significant history of renal or hepatic disease
  • History of a psychiatric disorder, alcohol or drug abuse within the previous year
  • Treatment with potent CYP3A4 inhibitors or inducers
  • Immunocompromised participants
  • Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests

Trial locations and contacts

41 sites in 4 countries.

41 sites in 4 countries

United States25 sites

  • Community Health Care Of Manchester

    Akron, Ohio, 44319

  • Central Florida Clinical Trials, Inc.

    Altamonte Springs, Florida, 32701

  • Midwest Regional Research, Inc.

    Bellbrook, Ohio, 45305

  • Family Care Associates Of Nw Florida

    Chipley, Florida, 32428

  • John Muir Physician Network Clinical Research Center

    Concord, California, 94520

  • Clinical Therapeutics Corporation

    Coral Gables, Florida, 33134

  • Williamette Valley Clinical Studies

    Eugene, Oregon, 97404

  • Integrated Medical Group Pc/Fleetwood Clinical Research

    Fleetwood, Pennsylvania, 19522

  • Southland Clinical Research Center, Inc.

    Fountain Valley, California, 92708

  • Village Family Practice

    Houston, Texas, 77024

  • Wells Institute For Health Awareness

    Kettering, Ohio, 45429

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Torrance Clinical Research

    Lomita, California, 90717

  • Nextphase Clinical Trials, Inc.

    Miami, Florida, 33145

  • Newark Physician Associates

    Newark, Ohio, 43055

  • Integris Family Care South

    Oklahoma City, Oklahoma, 73170

  • Southwest Clinical Research Centers, Llc

    Pearland, Texas, 77584

  • Middle Georgia Drug Study Center, Llc

    Perry, Georgia, 31069

  • Jackson Clinic

    Rolling Fork, Mississippi, 39159

  • Jolene K. Berg, Md., Dgd Research, Inc.

    San Antonio, Texas, 78229

  • Ritchken & First M.D.'S

    San Diego, California, 92117

  • Louisiana Heart Center Research

    Slidell, Louisiana, 70458

  • Southeastern Research Associates, Inc

    Taylors, South Carolina, 29687

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • Integris Family Care Yukon

    Yukon, Oklahoma, 73099

Other trials in United States

Germany7 sites

  • Local Institution

    Ludwigshafen, 67067

  • Local Institution

    Magdeberg, 39112

  • Local Institution

    Pirna, 01796

  • Local Institution

    Saarbrücken, 66119

  • Local Institution

    Saarlouis, 66740

  • Local Institution

    Tann, 36142

  • Local Institution

    Wüstensachsen, 36115

Other trials in Germany

Hungary5 sites

  • Local Institution

    Balatonfüred, Hungary, 8230

  • Local Institution

    Budapest, 1036

  • Local Institution

    Eger, 3300

  • Local Institution

    Szigetvár, 7900

  • Local Institution

    Zalaegerszeg, 8900

Other trials in Hungary

Puerto Rico4 sites

  • Local Institution

    Ponce, 00716

  • Local Institution

    San Juan, 00909

  • Local Institution

    San Juan, 00920

  • Local Institution

    San Juan, 00926

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Being tested
Saxagliptin plus metformin IR, Placebo plus metformin IR
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.

  • Saxagliptin plus metformin IRDrug

    Also called BMS-477118, Onglyza

    Tablets, Oral, 2.5 mg, Twice daily, 12 weeks

  • Placebo plus metformin IRDrug

    Tablets, Oral, Placebo, Twice daily, 12 weeks

Study groups in NCT00885378
Study groupRoleWhat they receive
Saxagliptin plus metformin IRActive comparatorNot described
Receives: Drug: Saxagliptin plus metformin IR
Placebo plus metformin IRPlacebo comparatorNot described
Receives: Drug: Placebo plus metformin IR

What is being measured

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

  1. Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12

    Mean change was adjusted for baseline.

    Measured: Baseline, Week 12

Secondary outcomes (3)

  1. Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)

    Mean change was adjusted for baseline.

    Measured: Baseline, Week 12

  2. Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12

    Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)

    Measured: Week 12

  3. Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12

    Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)

    Measured: Week 12

Timeline

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

  1. First posted22 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00885378
Sponsor's protocol ID
CV181-080
Other IDs
EUDRACT #: 2009-010224-25
Status last verified
May 2015
First submitted
21 Apr 2009
Last updated
1 Jun 2015
Data monitoring committee
No

Publications

  • White JL, Buchanan P, Li J, Frederich R. A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy. BMC Endocr Disord. 2014 Feb 24;14:17. doi: 10.1186/1472-6823-14-17.

    PubMed 24565221

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin plus metformin IR in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 41 sites in 4 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 6 inclusion and 14 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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Germany, Hungary, 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 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?

Yes. Results are posted in the registry (first posted 16 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 (time frame: Baseline, Week 12). 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 NCT00885378, 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 1 Jun 2015.

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