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Type 2 Diabetes MellitusPhase 4MEASURE-HFNCT02917031

Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure

A Phase 4 study testing Saxagliptin and Sitagliptin in people with Type 2 Diabetes Mellitus and Heart Failure, run by AstraZeneca at 74 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

This is a 24 week, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the effects of saxagliptin and sitagliptin on cardiac dimensions and function in patients with type 2 diabetes (T2DM) mellitus and heart failure (HF). Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Type 2 Diabetes Mellitus, Heart Failure
What is being tested?
Saxagliptin and Sitagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
348 participants
Where
74 sitesin 10 countries
Study dates
10 Jan 2017to 23 Aug 2019
Phase
Phase 4
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 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent prior to any study specific procedure (Pre-screening ICF and Informed Consent collected at screening)
  • Male or female, aged ≥18 years at the time of consent
  • Documented, controlled T2DM, as defined by:
  • Diagnosis of Type 2 DM based on current ADA guidelines (Appendix C) Treatment with stable doses of antidiabetic medications that have not increased or decreased for ≥8 weeks before screening
  • For patients taking insulin, the investigator must query the patient at prescreening or screening regarding his/her usual total daily insulin dose (all types combined) during the previous 8 weeks. Insulin dosages during pre-screening and screening should not vary by more than ±20% on more than two occasions
  • Dosage reductions of insulin and sulfonylurea agents may be considered at randomization to minimize the possibility of hypoglycemia
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  • Any reductions in the dosage of insulin and sulfonylurea agents will be at the discretion of the investigator
  • For patients treated with insulin, consider a reduction in dose of 20% at randomization
  • For patients receiving sulfonylurea agents, consider a reduction in dose of 50% or discontinue if on a dosage that is considered low at randomization
  • HFrEF demonstrated by all 3 of the following criteria:
  • History of HF and LVEF ≤45% within the last 6 months (echocardiogram, MRI, left ventriculography, or other accepted methodology). Patients without a recent assessment of LV function will undergo a local echocardiogram at the time of screening to determine ejection fraction
  • Elevated NT-proBNP (>300 pg/mL) during screening
  • Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines as appropriate. Guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated. Therapy should have been individually optimized and stable for >or = 4 weeks (this does not apply to diuretics-see NB below) before screening visit and include (unless contraindicated or not tolerated):
  • an ACE inhibitor, or ARB, or sacubitril/valsartan
  • and
  • a beta-blocker
  • and
  • if considered appropriate by the patient's treating physician; a mineralocorticoid receptor antagonist (MRA)
  • NB: Most patients with heart failure require treatment with a diuretic to control sodium and water retention leading to volume overload. It is recognized that diuretic dosing may be titrated to symptoms, signs, weight, and other information and may thus vary. Each patient should, however, be treated with a diuretic regimen aimed at achieving optimal fluid/volume status for that individual
  • Stable HF, with no evidence of volume overload (no rales, jugular venous distention, peripheral edema) at screening
  • Women of childbearing potential (WOCBP):
  • Must be using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product
  • Must have a negative serum or urine pregnancy test within 72 hours prior to the start of investigational product
  • Must not be breastfeeding.

Who cannot join

  • MRI contraindications: all implanted defibrillators; implanted pacemakers and other devices/implants that in the judgment of the investigator preclude an MRI evaluation
  • Patients with atrial fibrillation/flutter, or any rhythm that would impact on MRI imaging quality would be excluded. Patients with a prior history of atrial fibrillation or paroxysmal atrial fibrillation may be eligible for entry into the study based on the investigator's judgment related to the frequency of AF events and the patient's overall condition
  • Body mass index >45 kg/m2 or any condition, including, but not limited to known claustrophobia, that may preclude the ability to perform an MRI scan of acceptable quality, or unwillingness to undergo MRI imaging
  • Receiving incretin therapy (DPP4 inhibitors, GLP-1 mimetics), or having received incretin therapy within the previous 8 weeks of randomization
  • Receiving therapy with a TZD or having received TZD therapy within the previous 8 weeks of randomization
  • Type 1 diabetes mellitus
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  • History of unstable or rapidly progressing renal disease
  • A central lab eGFR value <30 mL/min/1.73 m2 on pre-screening or screening
  • New York Heart Association (NYHA) Class IV HF
  • Myocardial infarction, stroke, transient ischemic attack, or coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) within the past 3 months of screening
  • Inoperable aortic or mitral valvular heart disease. Recent (within 3 months) or planned valvular heart procedure
  • Heart failure secondary to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, and hypertrophic obstructive cardiomyopathy
  • Previous cardiac transplantation or transplantation indicated or expected within 6 months of randomization
  • Contraindications to saxagliptin therapy as outlined in the saxagliptin Investigator's Brochure, or to sitagliptin therapy as outlined in the sitagliptin prescribing information
  • Current treatment with strong cytochrome P450 (CYP) 3A4/5 inhibitors
  • Involvement in the planning and/or conduct of the study (applies to both AZ staff and/or staff at the study site)
  • Previous enrollment which disqualifies patient from re-enrollment based on the rules in Section 4.1 of the protocol, or previous randomization in the study
  • Participation in another clinical study with an investigational product during the last 30 days
  • Patients either employed by or immediate relatives of the Sponsor
  • Known human immunodeficiency virus (HIV) infection
  • Severe hepatic disease, including chronic active hepatitis. Positive serologic evidence of current infectious liver disease, including patients who are known to be positive for hepatitis B viral antibody IgM, hepatitis B surface antigen, or hepatitis C virus antibody; or aspartate transaminase (AST) or alanine transaminase (ALT) >3X the upper limit of normal; or total bilirubin (TB) >2 mg/dL
  • Active malignancy requiring treatment at the time of Visit 1(with the exception of successfully treated basal cell or treated squamous cell carcinoma).
  • Pregnant, positive pregnancy test, planning to become pregnant during clinical trial or breast feeding
  • History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the patient at risk because of participation in the study, may influence the results, or may limit the patient's ability to participate in or complete the study
  • Unable or unwilling to provide written informed consent

Trial locations and contacts

74 sites in 10 countries.

74 sites in 10 countries

Russia15 sites

  • Research Site

    Izhevsk, 426035

  • Research Site

    Kemerovo, 650002

  • Research Site

    Moscow, 109263

  • Research Site

    Moscow, 115516

  • Research Site

    Moscow, 121551

  • Research Site

    Nizhny Novgorod, 603018

  • Research Site

    Novosibirsk, 630055

  • Research Site

    Novosibirsk, 630087

  • Research Site

    Novosibirsk, 630089

  • Research Site

    Saint Petersburg, 194354

  • Research Site

    Saint Petersburg, 197341

  • Research Site

    Saint Petersburg, 199226

  • Research Site

    Tomsk, 634012

  • Research Site

    Tomsk, 634050

  • Research Site

    Yaroslavl, 150062

Other trials in Russia

Hungary12 sites

  • Research Site

    Balatonfüred, 8230

  • Research Site

    Budapest, 1122

  • Research Site

    Budapest, 1134

  • Research Site

    Budapest, 1171

  • Research Site

    Debrecen, 4032

  • Research Site

    Hajdúszoboszló, 4200

  • Research Site

    Kecskemét, 6000

  • Research Site

    Kisvárda, 4600

  • Research Site

    Nyíregyháza, 4400

  • Research Site

    Orosháza, 5900

  • Research Site

    Pécs, 7623

  • Research Site

    Székesfehérvár, 8000

Other trials in Hungary

United States11 sites

  • Research Site

    Chicago, Illinois, 60610

  • Research Site

    Houston, Texas, 77089

  • Research Site

    Miami, Florida, 33133

  • Research Site

    Milwaukee, Wisconsin, 64111

  • Research Site

    Ormond Beach, Florida, 32174

  • Research Site

    Sayre, Pennsylvania, 18840

  • Research Site

    Spartanburg, South Carolina, 29302

  • Research Site

    The Bronx, New York, 10455

  • Research Site

    The Bronx, New York, 10459

  • Research Site

    Torrance, California, 90502

  • Research Site

    Upland, California, 91786

Other trials in United States

South Korea9 sites

  • Research Site

    Busan, 49241

  • Research Site

    Daejeon, 35015

  • Research Site

    Gwangju, 61469

  • Research Site

    Hwaseong-si, 18450

  • Research Site

    Seongnam-si, 13620

  • Research Site

    Seoul, 02841

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Wŏnju, 26426

Other trials in South Korea

Ukraine7 sites

  • Research Site

    Ivano-Frankivsk, 76005

  • Research Site

    Ivano-Frankivsk, 76018

  • Research Site

    Kyiv, 02091

  • Research Site

    Kyiv, 02660

  • Research Site

    Kyiv, 03680

  • Research Site

    Lviv, 79015

  • Research Site

    Rivne, 33007

Other trials in Ukraine

Chile6 sites

  • Research Site

    Santiago, 8207257

  • Research Site

    Santiago, 8360160

  • Research Site

    Santiago, 8380453

  • Research Site

    Santiago, 8910259

  • Research Site

    Talcahuano, 4270918

  • Research Site

    Viña del Mar, 2520997

Other trials in Chile

Bulgaria5 sites

  • Research Site

    Sofia, 1142

  • Research Site

    Sofia, 1431

  • Research Site

    Sofia, 1606

  • Research Site

    Sofia, 1618

  • Research Site

    Sofia, 1784

Other trials in Bulgaria

Thailand5 sites

  • Research Site

    Bangkok, 10330

  • Research Site

    Bangkok, 10400

  • Research Site

    Bangkoknoi, 10700

  • Research Site

    Chiang Mai, 50200

  • Research Site

    Khon Kaen, 40002

Other trials in Thailand

Romania3 sites

  • Research Site

    Brasov, 500365

  • Research Site

    Iași, 700304

  • Research Site

    Iași, 700515

Other trials in Romania

Canada1 site

  • Research Site

    Chicoutimi, Quebec, G7H 7K9

Other trials in Canada

About this study

Official title: A 24-Week, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Effects of Saxagliptin and Sitagliptin in Patients With Type 2 Diabetes Mellitus and Heart Failure

This is a 24 week, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the effects of saxagliptin and sitagliptin on cardiac dimensions and function in patients with type 2 diabetes (T2DM) mellitus and heart failure (HF).

Being tested
Saxagliptin, Sitagliptin, Placebo to match saxagliptin, Placebo to match sitagliptin
Keywords
Type 2 Diabetes Mellitus, Heart Failure, Saxagliptin, Sitagliptin
Medical subject headings
Diabetes Mellitus, Type 2, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SaxagliptinDrug

    Also called Onglyza TM

    5 mg or 2.5 mg, plain, yellow, biconvex, round, film-coated tablet

  • SitagliptinDrug

    Also called Januvia®

    50 mg or 100 mg, gray capsule

  • Placebo to match saxagliptinDrug

    2.5 mg or 5 mg, plain, yellow, biconvex, round, film-coated tablet

  • Placebo to match sitagliptinDrug

    50 mg or 100 mg, gray capsule

Study groups in NCT02917031
Study groupRoleWhat they receive
SaxagliptinActive comparatorone tablet of saxagliptin 5 mg or 2.5 mg + one placebo capsule matching sitagliptin
Receives: Drug: Saxagliptin; Drug: Placebo to match sitagliptin
SitagliptinActive comparatorone capsule of sitagliptin 100 mg or 50 mg + one placebo tablet matching saxagliptin
Receives: Drug: Sitagliptin; Drug: Placebo to match saxagliptin
PlaceboPlacebo comparatorone placebo tablet matching saxagliptin + one placebo capsule matching sitagliptin
Receives: Drug: Placebo to match saxagliptin; Drug: Placebo to match sitagliptin

What is being measured

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

  1. Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) Index Measured by Magnetic Resonance Imaging (MRI) at 24 Weeks

    MRI was performed to evaluate LVEDV at baseline and Visit 10 (Week 24). Evaluated to exclude an increase in left ventricular end diastolic volume (LVEDV) index of greater than 10% of the overall baseline value (noninferiority margin) in patients with T2DM and HF treated with saxagliptin for 24 weeks, compared to placebo. Baseline is last assessment on or before the date of first dose.

    Measured: Baseline to 24 weeks

Secondary outcomes (5)

  1. Change From Baseline in Left Ventricular End Systolic Volume (LVESV) Index, Measured by MRI at 24 Weeks.

    Evaluation of the effects of saxagliptin compared to placebo on left ventricular end systolic volume (LVESV) index, after 24 weeks in patients with T2DM and HF.

    Measured: Baseline to week 24

  2. Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Measured by MRI at 24 Weeks.

    Evaluation the effects of saxagliptin compared to placebo on left ventricular end systolic volume (LVESV) index, left ventricular ejection fraction (LVEF), and left ventricular mass (LVM) after 24 weeks in patients with T2DM and HF.

    Measured: Baseline to week 24

  3. Change From Baseline in Left Ventricular Mass (LVM) Measured by MRI at 24 Weeks.

    Evaluation of the effects of saxagliptin compared to placebo on left ventricular mass (LVM) after 24 weeks in patients with T2DM and HF.

    Measured: At 24 week

  4. Change From Baseline in NT-proBNP After 24 Weeks of Treatment

    Evaluation of the effects of saxagliptin compared to placebo on N-terminal prohormone of brain natriuretic peptide (NT-proBNP) after 24 weeks of treatment.

    Measured: Baseline to Week 28 (End of Study visit [EoS])

  5. Number of Participants With Adverse Events

    Assessment of safety and tolerability of saxagliptin and sitagliptin treatment in patients with T2DM and HF

    Measured: From screening (Days -28 to -1) until Week 28 (follow-up visit)

Timeline

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

  1. First posted28 Sep 2016 (estimated)
  2. Study start10 Jan 2017
  3. Primary completion23 Aug 2019
  4. Study completion23 Aug 2019

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02917031
Sponsor's protocol ID
D1680C00016
Acronym
MEASURE-HF
Status last verified
Oct 2021
First submitted
9 Sep 2016
Last updated
8 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.

    PubMed 34693515

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saxagliptin and Sitagliptin in people with Type 2 Diabetes Mellitus and Heart Failure, run by AstraZeneca at 74 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 24 inclusion and 25 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 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Russia, Hungary, United States, South Korea, Ukraine 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Jun 2021). 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?

Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV) Index Measured by Magnetic Resonance Imaging (MRI) at 24 Weeks (time frame: Baseline to 24 weeks). 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 NCT02917031, 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 8 Nov 2021.

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