Type 2 DiabetesPhase 3NCT02284893
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
A Phase 3 study testing Saxagliptin, Dapagliflozin and Sitagliptin in people with Type 2 Diabetes, run by AstraZeneca at 79 sites in 6 countries.
Trial summary
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Saxagliptin, Dapagliflozin and Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 461 participants
- Where
- 79 sitesin 6 countries
- Study dates
- 9 Sep 2014to 20 Sep 2016
- 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
- Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit
- Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening
- BMI > 20.0 kg/m2 at the enrollment visit
- Males and Females, age ≥18 years old at time of screening visit
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
- Women must not be breastfeeding
Who cannot join
- Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus
- History of diabetic ketoacidosis
- Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit
- Myocardial infarction
- Cardiac surgery or revascularization (coronary artery bypass surgery Coronary Artery Bypass Graft [(CABG)]/percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty [(PTCA)])
- Unstable angina
Show all 15Show fewer
- Unstable congestive heart failure (CHF)
- Transient ischemic attack (TIA) or significant cerebrovascular disease
- Unstable or previously undiagnosed arrhythmia
- Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute congestive heart failure and/or known left ventricular ejection fraction of ≤ 40%
- Renal Disease
- Hepatic Diseases
- Hematological and Oncological Disease/Conditions
- Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women
- Abnormal Free T4
Trial locations and contacts
79 sites in 6 countries.
79 sites in 6 countries
United States40 sites
Research Site
Bristol, Tennessee, 37620
Research Site
Charlotte, North Carolina, 28204
Research Site
Chicago, Illinois, 60634
Research Site
Columbia, South Carolina, 29204
Research Site
Coral Gables, Florida, 33134
Research Site
Council Bluffs, Iowa, 51503
Research Site
Crestview Hills, Kentucky, 41017
Research Site
Dallas, Texas, 75230
Research Site
Golden, Colorado, 80401
Research Site
Houston, Texas, 77081
Research Site
Huntington Beach, California, 92648
Research Site
Huntington Park, California, 90255
Research Site
Kenosha, Wisconsin, 53142
Research Site
Kissimmee, Florida, 34744
Research Site
Little Rock, Arkansas, 72205
Research Site
Lomita, California, 90717
Research Site
Los Angeles, California, 90057
Research Site
Manassas, Virginia, 20110
Research Site
Mesa, Arizona, 85206
Research Site
Mesa, Arizona, 85213
Research Site
Miami, Florida, 33015
Research Site
Miami, Florida, 33135
Research Site
Miami, Florida, 33174
Research Site
Miami Beach, Florida, 33140
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Morehead City, North Carolina, 28557
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Norman, Oklahoma, 73069
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North Richland Hills, Texas, 76180
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Northridge, California, 91325
Research Site
Norwalk, California, 90650
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Palm Harbor, Florida, 34684
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Paramount, California, 90723
Research Site
Pasadena, Texas, 77504
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Pembroke Pines, Florida, 33026
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Phoenix, Arizona, 85020
Research Site
Sacramento, California, 95823
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Salisbury, North Carolina, 28144
Research Site
San Antonio, Texas, 78229
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Suffolk, Virginia, 23452
Research Site
Tarzana, California, 91356
Research Site
Tustin, California, 92780
Poland9 sites
Research Site
Bialystok, 15-879
Research Site
Gdansk, 80-546
Research Site
Krakow, 31-156
Research Site
Krakow, 31-261
Research Site
Opole, 45-367
Research Site
Poznan, 61-655
Research Site
Warsaw, 02-507
Research Site
Wroclaw, 50-349
Research Site
Wroclaw, 51-685
Romania9 sites
Research Site
Brasov, 500269
Research Site
Bucharest, 011794
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Bucharest, 020359
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Buzău, 120203
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Craiova, 200349
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Galati, 800098
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Oradea, 410169
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Satu Mare, 440055
Research Site
Timișoara, 300736
Hungary7 sites
Research Site
Baja, 6500
Research Site
Budapest, 1036
Research Site
Budapest, 1097
Research Site
Debrecen, 4032
Research Site
Gyula, 5700
Research Site
Nyíregyháza, 4405
Research Site
Szekszárd, 7100
Mexico7 sites
Research Site
Aguascalientes, 20230
Research Site
Chihuahua City, 31217
Research Site
Cuautla, 62746
Research Site
Guadalajara, 44130
Research Site
Guadalajara, 44160
Research Site
Guadalajara, 44670
Research Site
Monterrey, 64460
South Africa7 sites
Research Site
Boksburg North, 1460
Research Site
Cape Town, 7700
Research Site
Durban, 4091
Research Site
Johannesburg, 1818
Research Site
Lenasia, 1829
Research Site
Moloto South, 1022
Research Site
Soweto, 2013
About this study
Official title: A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- Saxagliptin, Dapagliflozin, Sitagliptin, Placebo matching with Saxagliptin, Placebo matching with Dapagliflozin
- 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.
SaxagliptinDrug
administered orally once daily
DapagliflozinDrug
administered orally once daily
SitagliptinDrug
administered orally once daily
Placebo matching with SaxagliptinDrug
administered orally once daily
Placebo matching with DapagliflozinDrug
administered orally once daily
Placebo matching with SitagliptinDrug
administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| A1:Saxagliptin / Placebo + Dapagliflozin / Placebo | Experimental | Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily) Receives: Drug: Saxagliptin; Drug: Dapagliflozin; Drug: Placebo matching with Saxagliptin; Drug: Placebo matching with Dapagliflozin |
| A2: Sitagliptin / placebo | Experimental | Sitagliptin 100 mg and matching placebo 0 mg (once daily) Receives: Drug: Sitagliptin; Drug: Placebo matching with Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in HbA1c
Measured: Baseline (randomization) to Week 26
Secondary outcomes (3)
Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%
Measured: week 26
Mean Change in Total Body Weight
Measured: Baseline (randomization) to Week 26
Mean Change in Fasting Plasma Glucose (FPG)
Measured: Baseline (randomization) to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study start9 Sep 2014
- Primary completion20 Sep 2016
- Study completion20 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Astra Zeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284893
- Sponsor's protocol ID
- CV181-363
- Other IDs
- 2014-001102-17, 2014
- Status last verified
- May 2018
- First submitted
- 4 Nov 2014
- Last updated
- 1 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
- ClinicalTrials.gov ID
- NCT02284893
- Acronym / sponsor ID
- CV181-363
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2014 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 1 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1:Saxagliptin / Placebo + Dapagliflozin / Placebo | Experimental | Drug: Saxagliptin, Drug: Dapagliflozin, Drug: Placebo matching with Saxagliptin, Drug: Placebo matching with DapagliflozinSaxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily) |
| A2: Sitagliptin / placebo | Experimental | Drug: Sitagliptin, Drug: Placebo matching with SitagliptinSitagliptin 100 mg and matching placebo 0 mg (once daily) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control, defined as a central laboratory glycosylated hemoglobin (HbA1c) ≥8.0% and ≤ 10.5 % obtained at the screening visit
- Subjects should have been taking the same daily dose of metformin ≥ 1500 mg for at least 8 weeks prior to the enrollment visit and with no intake of other antihyperglycemic therapy for more than 14 days (consecutive or not) during 12 weeks prior to screening
- BMI > 20.0 kg/m2 at the enrollment visit
- Males and Females, age ≥18 years old at time of screening visit
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
Key exclusion criteria (15 listed)
- Clinically diagnosed with Type I diabetes, known diagnosis of Maturity Onset Diabetes of Young (MODY), secondary diabetes mellitus or diabetes insipidus
- History of diabetic ketoacidosis
- Any of the following cardiovascular (CV)/Vascular Diseases within 3 months of the enrollment visit
- Renal Disease
- Hepatic Diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saxagliptinadministered orally once daily | Drug | A1:Saxagliptin / Placebo + Dapagliflozin / Placebo |
| Dapagliflozinadministered orally once daily | Drug | A1:Saxagliptin / Placebo + Dapagliflozin / Placebo |
| Sitagliptinadministered orally once daily | Drug | A2: Sitagliptin / placebo |
| Placebo matching with Saxagliptinadministered orally once daily | Drug | A1:Saxagliptin / Placebo + Dapagliflozin / Placebo |
| Placebo matching with Dapagliflozinadministered orally once daily | Drug | A1:Saxagliptin / Placebo + Dapagliflozin / Placebo |
| Placebo matching with Sitagliptinadministered orally once daily | Drug | A2: Sitagliptin / placebo |
Primary outcome
Mean Change in HbA1c
Time frame: Baseline (randomization) to Week 26
3 secondary outcomes
Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%
Time frame: week 26
Mean Change in Total Body Weight
Time frame: Baseline (randomization) to Week 26
Mean Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline (randomization) to Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astra Zeneca study director
AstraZeneca
79 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saxagliptin, Dapagliflozin and Sitagliptin in people with Type 2 Diabetes, run by AstraZeneca at 79 sites in 6 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 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 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Poland, Romania, Hungary, Mexico and 1 more country. 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 1 Jun 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 in HbA1c (time frame: Baseline (randomization) to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2018.