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Type 2 Diabetes MellitusPhase 3NCT02551874

A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

A Phase 3 study testing Saxagliptin, Onglyza, Dapagliflozin, Farxiga and Glargine insulin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 40 sites in 10 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

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Saxagliptin, Onglyza, Dapagliflozin, Farxiga and Glargine insulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
40 sitesin 10 countries
Study dates
20 Oct 2015to 10 Nov 2017
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 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age at screening
  • HbA1c ≥ 8% and ≤ 12% at screening
  • Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)
  • Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks
  • estimated glomerular filtration rate (eGFR) \< 60 ml/ml/1.73m2
  • Body Mass Index ≤ 45.0 kg/m2

Who cannot join

  • Clinical diagnosis of Type 1 diabetes
  • History of ketoacidosis
  • Renal, hepatic or pancreatic disease
  • Impairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min
  • Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance [CrCl] < 60 mL/min

Trial locations and contacts

40 sites in 10 countries.

40 sites in 10 countries

United States20 sites

  • Research Site

    Anaheim, California, 92801

  • Research Site

    Barto, Pennsylvania, 19504

  • Research Site

    Beavercreek, Ohio, 45432

  • Research Site

    Bountiful, Utah, 84010

  • Research Site

    Bristol, Tennessee, 37620

  • Research Site

    Chicago, Illinois, 60612

  • Research Site

    Columbia, South Carolina, 29204

  • Research Site

    Houston, Texas, 77004

  • Research Site

    Kingsport, Tennessee, 37660

  • Research Site

    Lexington, Kentucky, 40502

  • Research Site

    Los Angeles, California, 90057

  • Research Site

    Mesquite, Texas, 74194

  • Research Site

    Miami, Florida, 33144

  • Research Site

    Miami, Florida, 33155

  • Research Site

    Norcross, Georgia, 30071

  • Research Site

    Norman, Oklahoma, 73069

  • Research Site

    Quincy, Massachusetts, 02169

  • Research Site

    San Antonio, Texas, 78230

  • Research Site

    San Antonio, Texas, 78258

  • Research Site

    St. Petersburg, Florida, 33709

Other trials in United States

Mexico4 sites

  • Research Site

    Guadalajara, 44670

  • Research Site

    México, 03800

  • Research Site

    Monterrey, 64460

  • Research Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Romania4 sites

  • Research Site

    Craiova, 200349

  • Research Site

    Ploieşti, 100018

  • Research Site

    Timișoara, 300125

  • Research Site

    Timișoara, 300456

Other trials in Romania

Hungary3 sites

  • Research Site

    Budapest, 1032

  • Research Site

    Budapest, 1097

  • Research Site

    Budapest, 1171

Other trials in Hungary

Poland3 sites

  • Research Site

    Lodz, 92-003

  • Research Site

    Nowy Duninów, 09-505

  • Research Site

    Sochaczew, 96-500

Other trials in Poland

Czechia2 sites

  • Research Site

    Karlovy Vary, 360 01

  • Research Site

    Olomouc, 772 00

Other trials in Czechia

Denmark1 site

  • Research Site

    Copenhagen, 2400

Other trials in Denmark

South Africa1 site

  • Research Site

    Lenasia, 1827

Other trials in South Africa

Spain1 site

  • Research Site

    A Coruña, 15006

Other trials in Spain

Sweden1 site

  • Research Site

    Uddevalla, 451 80

Other trials in Sweden

About this study

Official title: A 24-week International, Multicenter, Randomized, Open-Label, Active-Controlled, Parallel Group, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin With or Without Sulfonylurea Therapy

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

Read the detailed description

CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

Being tested
Saxagliptin, Onglyza, Dapagliflozin, Farxiga, Glargine insulin, 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.

  • Saxagliptin, OnglyzaDrug

    Also called Onglyza

    Tablets, Oral, 5mg , Once daily, 24 weeks

  • Dapagliflozin, FarxigaDrug

    Also called BMS-512148

    Tablets, Oral, 10mg , Once daily, 24 weeks

  • Glargine insulinDrug

    Also called Lantus

    100 Units/ml solution for injection in a prefilled SoloStar pen

  • MetforminDrug

    Also called Glucophage

    Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks

Study groups in NCT02551874
Study groupRoleWhat they receive
Saxagliptin/Dapagliflozin/MetforminExperimentalOral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin
Receives: Drug: Saxagliptin, Onglyza; Drug: Dapagliflozin, Farxiga; Drug: Metformin
Insulin Glargine, Lantos/MetforminActive comparatorInsulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units.
Receives: Drug: Glargine insulin

What is being measured

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

  1. Mean Change From Baseline in HbA1c at Week 24

    To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

    Measured: Baseline and Week 24

Secondary outcomes (5)

  1. Mean Change From Baseline in Total Body Weight at Week 24

    To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment

    Measured: Baseline and Week 24

  2. Percentage of Subjects With Confirmed Hypoglycaemia at Week 24

    Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L)

    Measured: Baseline and Week 24

  3. Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24

    To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

    Measured: Baseline and Week 24

  4. Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24

    To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.

    Measured: Baseline and Week 24

  5. Change From Baseline in the Mean Value of 24-hour Glucose at Week 2

    Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment.

    Measured: Baseline and Week 2

Timeline

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

  1. First posted16 Sep 2015 (estimated)
  2. Study start20 Oct 2015
  3. Primary completion8 May 2017
  4. Study completion10 Nov 2017

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
None (open label)
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02551874
Sponsor's protocol ID
CV181-369
Other IDs
2015-001702-33, 2015
Status last verified
Nov 2018
First submitted
15 Sep 2015
Last updated
11 Dec 2018
Data monitoring committee
No

Publications

  • Vilsboll T, Ekholm E, Johnsson E, Dronamraju N, Jabbour S, Lind M. Dapagliflozin Plus Saxagliptin Add-on Therapy Compared With Insulin in Patients With Type 2 Diabetes Poorly Controlled by Metformin With or Without Sulfonylurea Therapy: A Randomized Clinical Trial. Diabetes Care. 2019 Aug;42(8):1464-1472. doi: 10.2337/dc18-1988. Epub 2019 Jun 4.

    PubMed 31167892

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin, Onglyza, Dapagliflozin, Farxiga and Glargine insulin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 40 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 6 inclusion and 5 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Mexico, Romania, Hungary, Poland 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. 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 18 Sep 2018). 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 Change From Baseline in HbA1c at Week 24 (time frame: Baseline and 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 NCT02551874, 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 11 Dec 2018.

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