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Type 2 DiabetesPhase 3NCT00757588

Safety and Efficacy of Saxagliptin Plus Insulin With or Without Metformin

A Phase 3 study testing Saxagliptin, 5 mg + insulin in people with Type 2 Diabetes, run by AstraZeneca at 80 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks. Read more about this study

Who is it for?
Ages 18 to 78 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Saxagliptin, 5 mg + insulin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
455 participants
Where
80 sitesin 10 countries
Study dates
Nov 2008to Apr 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 mellitus
  • Must have been taking a stable dose of basal or premixed insulin for 8 weeks or longer prior to screening
  • If taking metformin, must have been taking the same daily dose for 8 weeks or longer prior to screening
  • Insulin type should be intermediate- or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as 1 component).
  • Inadequate glycemic control (A1C of 7.5% to 11.0%, inclusive)
  • Body mass index of 45 kg/m² or lower
  • Fasting C-peptide level of 0.8 ng/mL or higher

Who cannot join

  • Symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the last 3 months prior to screening or other signs and symptoms
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Women of childbearing potential unable or unwilling to use acceptable birth control
  • Women who are pregnant or breastfeeding
  • Active liver disease
  • Anemia
Show all 15Show fewer
  • Chronic or repeated intermittent corticosteroid treatment (participants receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled)
  • Use of short- or rapid-acting insulin
  • Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident
  • Congestive heart failure
  • Unstable or rapidly progressing renal disease
  • History of alcohol or drug abuse within the previous year
  • History of hemoglobinopathies
  • Unstable major psychiatric disorders
  • Immunocompromised status

Trial locations and contacts

80 sites in 10 countries.

80 sites in 10 countries

United States16 sites

  • Central Florida Clinical Trials, Inc.

    Altamonte Springs, Florida, 32701

  • Family Care Associates Of Nw Florida

    Chipley, Florida, 32428

  • Valley Research

    Fresno, California, 93720

  • Texas Center For Drug Development

    Houston, Texas, 77081

  • Torrance-Lomita Medical Center

    Lomita, California, 90717

  • Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc.

    Marianna, Florida, 32446

  • Aurora Advanced Healthcare

    Milwaukee, Wisconsin, 53209

  • Diabetes Medical Center Of California

    Northridge, California, 91325

  • Danny W. Jackson P.A.

    Rolling Fork, Mississippi, 39159

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Dgd Research, Inc.

    San Antonio, Texas, 78229

  • Ritchken & First M.D.'S

    San Diego, California, 92117

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Southeastern Research Associates, Inc.

    Taylors, South Carolina, 29687

  • Clinical Research Advantage, Inc

    Tempe, Arizona, 85282

  • Southgate Medical Group

    West Seneca, New York, 14224

Other trials in United States

Mexico10 sites

  • Local Institution

    Aguascalientes, Aguascalientes, 20127

  • Local Institution

    Aguascalientes, Aguascalientes, 20230

  • Local Institution

    Mexico City, Mexico City, 06700

  • Local Institution

    Mexico City, Mexico City, 14000

  • Local Institution

    Monterrey, Nuevo León, 64060

  • Local Institution

    Monterrey, Nuevo León, 64240

  • Local Institution

    Monterrey, Nuevo León, 64710

  • Local Institution

    Monterrrey, Nuevo León, 64700

  • Local Institution

    Veracruz, Veracruz, 91700

  • Local Institution

    Zapopan, Jal., Jalisco, 45150

Other trials in Mexico

Canada9 sites

  • Local Institution

    Bathurst, New Brunswick, E2A 4X7

  • Local Institution

    Calgary, Alberta, T3B 0M3

  • Local Institution

    Charlottetown, Prince Edward Island, C1A 5Y9

  • Local Institution

    Gatineau, Quebec, J8V 2P5

  • Local Institution

    Laval, Quebec, H7T 2P5

  • Local Institution

    London, Ontario, N6A 4V2

  • Local Institution

    Regina, Saskatchewan, S4P 0W5

  • Local Institution

    Sherbrooke, Quebec, J1G 5K2

  • Local Institution

    Vancouver, British Columbia, V6E 1M7

Other trials in Canada

Poland9 sites

  • Local Institution

    Elblag, 82-300

  • Local Institution

    Gdansk, 80-286

  • Local Institution

    Krakow, 30-510

  • Local Institution

    Lodz, 90-153

  • Local Institution

    Lublin, 20-950

  • Local Institution

    Sopot, 81-756

  • Local Institution

    Szczecin, 71-455

  • Local Institution

    Wroclaw, 50-088

  • Local Institution

    Zabrze, 41-800

Other trials in Poland

Russia9 sites

  • Local Institution

    Kursk, 305035

  • Local Institution

    Saint Petersburg, 191015

  • Local Institution

    Saint Petersburg, 194156

  • Local Institution

    Saint Petersburg, 195257

  • Local Institution

    Saint Petersburg, 197022

  • Local Institution

    Saint Petersburg, 198013

  • Local Institution

    Saratov, 410031

  • Local Institution

    Smolensk, 214018

  • Local Institution

    Yaroslaval, 150062

Other trials in Russia

India7 sites

  • Local Institution

    Hariyāna, 132001

  • Local Institution

    Indore, Madhya Pradesh, 452001

  • Local Institution

    Mumbai, 400007

  • Local Institution

    Pune, 411 030

  • Local Institution

    Pune, 411011

  • Local Institution

    Pune, 411037

  • Local Institution

    Vellore, 632004

Other trials in India

Hungary6 sites

  • Local Institution

    Balatonfüred, 8230

  • Local Institution

    Budapest, 1041

  • Local Institution

    Budapest, 1083

  • Local Institution

    Budapest, 1212

  • Local Institution

    Szentes, 6600

  • Local Institution

    Zalaegerszeg-Pozva, 8900

Other trials in Hungary

South Africa5 sites

  • Local Institution

    Durban, KwaZulu-Natal, 4001

  • Local Institution

    Goodwood, Western Cape, 7460

  • Local Institution

    Parktown, Gauteng, 2193

  • Local Institution

    Tygerberg, Western Cape, 7505

  • Local Institution

    Umhlanga, KwaZulu-Natal, 4319

Other trials in South Africa

United Kingdom5 sites

  • Local Institution

    Birmingham, West Midlands, B9 5SS

  • Local Institution

    Middlesbrough, Cleveland, TS4 3BW

  • Local Institution

    Newcastle upon Tyne, Tyne and Wear, NE4 6BE

  • Local Institution

    Salford, Greater Manchester, M6 8HD

  • Local Institution

    Sheffield, Yorkshire, S5 7AU

Other trials in United Kingdom

France4 sites

  • Local Institution

    Besançon, 25030

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Nantes, 44093

  • Local Institution

    Valenciennes, 59300

Other trials in France

About this study

Official title: A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

Conditions
Type 2 Diabetes
Being tested
Saxagliptin, 5 mg + insulin, Placebo + insulin
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, 5 mg + insulinDrug

    Also called BMS-477118

    Saxagliptin, 5-mg tablets (plus stable insulin dose), given orally once daily (24 weeks short-term, 28 weeks long-term); participants stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue)

  • Placebo + insulinDrug

    Placebo tablets given orally once daily for 24 weeks (short-term period)+ insulin with metformin

Study groups in NCT00757588
Study groupRoleWhat they receive
Saxagliptin, 5 mg + insulinExperimentalSaxagliptin, 5 mg, plus insulin, administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
Receives: Drug: Saxagliptin, 5 mg + insulin
Placebo + insulinPlacebo comparatorPlacebo administered to participants with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin
Receives: Drug: Placebo + insulin

What is being measured

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

  1. Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])

    Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use

    Measured: Baseline to Week 24

Secondary outcomes (5)

  1. Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)

    An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal

    Measured: Baseline to Week 24

  2. Change From Baseline in 120-minute PPG Values During an MTT

    An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal.

    Measured: Baseline to Week 24

  3. Change From Baseline in Fasting Plasma Glucose Values

    Measured: Baseline to Week 24

  4. Percentage of Participants Achieving a Therapeutic Glycemic Response

    Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value.

    Measured: Baseline to Week 24

  5. Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)

    Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline.

    Measured: Baseline to Week 24

Timeline

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

  1. First posted23 Sep 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionApr 2010
  4. Study completionApr 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
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00757588
Sponsor's protocol ID
CV181-057
Other IDs
Eudract-2008-001089-10
Status last verified
May 2015
First submitted
22 Sep 2008
Last updated
1 Jun 2015
Data monitoring committee
Yes

Publications

  • Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

    PubMed 27402391

  • Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.

    PubMed 25414932

  • Barnett AH, Charbonnel B, Li J, Donovan M, Fleming D, Iqbal N. Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. Clin Drug Investig. 2013 Oct;33(10):707-17. doi: 10.1007/s40261-013-0107-8.

    PubMed 23949898

  • Barnett AH, Charbonnel B, Donovan M, Fleming D, Chen R. Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin. Curr Med Res Opin. 2012 Apr;28(4):513-23. doi: 10.1185/03007995.2012.665046. Epub 2012 Mar 1.

    PubMed 22313154

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin, 5 mg + insulin in people with Type 2 Diabetes, run by AstraZeneca at 80 sites in 10 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 7 inclusion and 15 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 80 sites in United States, Mexico, Canada, Poland, Russia and 5 more countries. 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 13 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?

Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (time frame: Baseline to Week 24). 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 NCT00757588, which also lists 4 linked publications.

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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