Type 2 Diabetes MellitusPhase 3NCT02681094
A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
A Phase 3 study testing Dapagliflozin and Saxagliptin in people with Type 2 Diabetes Mellitus and Inadequate Glycaemic Control, run by AstraZeneca at 110 sites in 6 countries.
Trial summary
The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Inadequate Glycaemic Control
- What is being tested?
- Dapagliflozin and Saxagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 905 participants
- Where
- 110 sitesin 6 countries
- Study dates
- 26 Feb 2016to 15 Jul 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years old at time of informed consent;
- Patients with Type 2 diabetes mellitus (T2DM) defined as HbA1C≥7.5% to ≤10.0% at screening visit;
- Stable metformin therapy for at least 8 weeks prior to enrolment at a dose of ≥1500mg per day;
- BMI ≤45.0kg/m2 at Enrolment visit;
- Fasting Plasma Glucose (FPG) ≤ 270mg/dl(15.0mmol/L) at the enrolment visit;
- For Females Only: Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study medication in such a manner that the risk of pregnancy is minimized.
Who cannot join
- History of diabetes insipidus, Type 1 diabetes or Latent Autoimmune Diabetes of Adults, diabetic ketoacidosis or hyperosmolar nonketotic coma and Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to Enrolment (Visit 1), or other signs and symptoms.
- History of pancreatitis.
- Administration of any antihyperglycaemic therapy, other than metformin, for more than 14 days (consecutive or not) during the 8 weeks prior to enrolment
- Any use of DPP-4 inhibitor or SGLT-2 inhibitor within 8 weeks prior to enrolment.
- Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency and/or significant abnormal liver function, including patients with Alanine transaminase (ALT) and/or Aspartate transaminase (AST) ≥3x ULN (Upper Limit of Normal)and/or Total Bilirubin ≥2.0x ULN. History of severe hepatobiliary disease or hepatotoxicity with any medication. Positive serologic evidence of current infectious liver disease, including patients who are known to be positive for Hepatitis viral antibody ImmunoglobulinM (IgM), Hepatitis B surface antigen, and Hepatitis C virus antibody.
- Moderate or severe impairment of renal function [defined as Estimated Glomerular Filtration Rate (eGFR) <60milliLitre/min/1.73 m2 (estimated by Modification in Diet and Renal Disease (MDRD)) or serum creatinine ≥1.5mg/dL in males or ≥1.4mg/dL in females]. Conditions of congenital renal glucosuria, history of unstable or rapidly progressing renal disease.
- 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.
Trial locations and contacts
110 sites in 6 countries.
110 sites in 6 countries
United States48 sites
Research Site
Albany, New York, 12203
Research Site
Asheville, North Carolina, 28801
Research Site
Biloxi, Mississippi, 39531
Research Site
Buford, Georgia, 30518
Research Site
Chicago, Illinois, 60607
Research Site
Columbus, Ohio, 43201
Research Site
Cooper City, Florida, 33024
Research Site
Dallas, Texas, 75208
Research Site
Dallas, Texas, 75230
Research Site
Denver, Colorado, 80220
Research Site
Doral, Florida, 33166
Research Site
East Providence, Rhode Island, 02914
Research Site
El Paso, Texas, 79935
Research Site
Fargo, North Dakota, 58103
Research Site
Florissant, Missouri, 63031
Research Site
Fort Worth, Texas, 76132
Research Site
Fresno, California, 93702
Research Site
Harbor City, California, 90710
Research Site
Hawaiian Gardens, California, 90716
Research Site
Hazel Crest, Illinois, 60429
Research Site
Hialeah, Florida, 33012
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77036
Research Site
Houston, Texas, 77040
Research Site
Lancaster, California, 93534
Research Site
Los Angeles, California, 90057
Research Site
Maumee, Ohio, 43537
Research Site
Miami, Florida, 33176
Research Site
Miami, Florida, 33186
Research Site
Miami Lakes, Florida, 33016
Research Site
Montclair, California, 91763
Research Site
Mooresville, North Carolina, 28117
Research Site
New Orleans, Louisiana, 70115
Research Site
Norfolk, Virginia, 23510
Research Site
Northglenn, Colorado, 80234
Research Site
Odessa, Texas, 79761
Research Site
Pomona, California, 91767
Research Site
Salt Lake City, Utah, 84102
Research Site
Saraland, Alabama, 36571
Research Site
Spring Valley, California, 91978
Research Site
Sugar Land, Texas, 77479
Research Site
The Bronx, New York, 10459
Research Site
Vallejo, California, 94592
Research Site
Waco, Texas, 76710
Research Site
Waterbury, Connecticut, 06708
Research Site
West Columbia, South Carolina, 29169
Research Site
Wheat Ridge, Colorado, 80033
Research Site
Zachary, Louisiana, 70791
Russia16 sites
Research Site
Arkhangelsk, 163001
Research Site
Izhevsk, 426063
Research Site
Kazan', 420008
Research Site
Moscow, 119991
Research Site
Moscow, 127473
Research Site
Perm, 614056
Research Site
Perm, 6144090
Research Site
Rostov-on-Don, 344022
Research Site
Saint Petersburg, 196143
Research Site
Saint Petersburg, 196601
Research Site
Saint Petersburg, 198013
Research Site
Tver', 170036
Research Site
Ufa, 450071
Research Site
Vladikavkaz, 362007
Research Site
Yekaterinburg, 620039
Research Site
Yekaterinburg, 620219
Germany14 sites
Research Site
Berlin, 10787
Research Site
Bünde, 32257
Research Site
Essen, 45359
Research Site
Giengen an der Brenz, 89537
Research Site
Großheirath, 96269
Research Site
Hof, 95030
Research Site
Hohenmölsen, 06679
Research Site
Karlsruhe, 76199
Research Site
Lichtenfels, 96215
Research Site
Meine, 38527
Research Site
Münster, 48153
Research Site
Rehburg-Loccum, 31547
Research Site
Stolberg, 52222
Research Site
Villingen-Schwenningen, 78048
Canada13 sites
Research Site
Brampton, Ontario, L7A 3P1
Research Site
Bridgewater, Nova Scotia, B4V 3N2
Research Site
Chicoutimi, Quebec, G7H 7K9
Research Site
Etobicoke, Ontario, M9W 4L6
Research Site
Greater Sudbury, Ontario, P3E 6C3
Research Site
Lévis, Quebec, G6W 0M5
Research Site
London, Ontario, N5W 6A2
Research Site
Mirabel, Quebec, J7J 2K8
Research Site
Moncton, New Brunswick, E1G 1A7
Research Site
Pointe-Claire, Quebec, H9R 3J1
Research Site
Saint-Marc-des-Carrieres, Quebec, G0A 4B0
Research Site
Scarborough Village, Ontario, M1P 2T7
Research Site
Toronto, Ontario, M3J 2C5
Czechia12 sites
Research Site
České Budějovice, 370 01
Research Site
Chrudim III, 537 01
Research Site
Jílové u Prahy, 254 01
Research Site
Ostrava, 710 00
Research Site
Pardubice, 530 02
Research Site
Pilsen, 301 66
Research Site
Prague, 100 00
Research Site
Prague, 140 46
Research Site
Prague, 149 00
Research Site
Prague, 181 00
Research Site
Praha Klanovice, 190 14
Research Site
Uherské Hradiště, 686 01
Mexico7 sites
Research Site
Guadalajara, 44160
Research Site
Guadalajara, 44600
Research Site
Guadalajara, 44670
Research Site
México, 03800
Research Site
Monterrey, 64460
Research Site
Monterrey, 64465
Research Site
Zapopan, 45116
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered With Dapagliflozin 5mg Compared to Saxagliptin 5mg or Dapagliflozin 5mg All Given as Add-on Therapy to Metformin inPatients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Alone
The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.
- Being tested
- Dapagliflozin, Placebo for Dapagliflozin, Saxagliptin, Placebo for Saxagliptin
- Keywords
- Diabetes Mellitus Type 2,, saxagliptin,, dapagliflozin,, 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.
DapagliflozinDrug
Also called Forxiga
5mg, orally, Green, plain, diamond-shaped, film-coated tablet
Placebo for DapagliflozinDrug
Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet
SaxagliptinDrug
Also called Onglyza™
5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
Placebo for SaxagliptinDrug
Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Saxagliptin+Dapagliflozin+Metformin | Active comparator | 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin Receives: Drug: Dapagliflozin; Drug: Saxagliptin |
| Dapagliflozin+Saxagliptin placebo+Metformin | Active comparator | 5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo Receives: Drug: Dapagliflozin; Drug: Placebo for Saxagliptin |
| Saxagliptin+Dapagliflozin placebo+metformin | Active comparator | 5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo Receives: Drug: Placebo for Dapagliflozin; Drug: Saxagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c at Week 24
To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set.
Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication.
Measured: Baseline and week 24
Secondary outcomes (3)
Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks
To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 <7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set.
Measured: Baseline and week 24
Change in Fasting Plasma Glucose at 24 Weeks
To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set.
Measured: Baseline and week 24
Change in Total Body Weight at 24 Weeks
To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set.
Measured: Baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study start26 Feb 2016
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
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 Diabetes MellitusStudies 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
- 905 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681094
- Sponsor's protocol ID
- D1683C00005
- Status last verified
- Sep 2018
- First submitted
- 10 Feb 2016
- Last updated
- 10 Oct 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 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Active-Controlled , Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered With Dapagliflozin 5mg Compared to Saxagliptin 5mg or Dapagliflozin 5mg All Given as Add-on Therapy to Metformin inPatients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Alone
- ClinicalTrials.gov ID
- NCT02681094
- Acronym / sponsor ID
- D1683C00005
- Keywords
- Diabetes Mellitus Type 2,, saxagliptin,, dapagliflozin,, metformin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 905 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Posted 10 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saxagliptin+Dapagliflozin+Metformin | Active comparator | Drug: Dapagliflozin, Drug: Saxagliptin5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin |
| Dapagliflozin+Saxagliptin placebo+Metformin | Active comparator | Drug: Dapagliflozin, Drug: Placebo for Saxagliptin5 mg Tablets, Oral, Once daily, 24 weeks for Dapagliflozin and Saxagliptin Placebo |
| Saxagliptin+Dapagliflozin placebo+metformin | Active comparator | Drug: Placebo for Dapagliflozin, Drug: Saxagliptin5 mg Tablets, Oral, Once daily, 24 weeks for Saxagliptin and Dapagliflozin placebo |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged ≥18 years old at time of informed consent;
- Patients with Type 2 diabetes mellitus (T2DM) defined as HbA1C≥7.5% to ≤10.0% at screening visit;
- Stable metformin therapy for at least 8 weeks prior to enrolment at a dose of ≥1500mg per day;
- BMI ≤45.0kg/m2 at Enrolment visit;
- Fasting Plasma Glucose (FPG) ≤ 270mg/dl(15.0mmol/L) at the enrolment visit;
Key exclusion criteria (7 listed)
- History of diabetes insipidus, Type 1 diabetes or Latent Autoimmune Diabetes of Adults, diabetic ketoacidosis or hyperosmolar nonketotic coma and Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to Enrolment (Visit 1), or other signs and symptoms.
- History of pancreatitis.
- Administration of any antihyperglycaemic therapy, other than metformin, for more than 14 days (consecutive or not) during the 8 weeks prior to enrolment
- Any use of DPP-4 inhibitor or SGLT-2 inhibitor within 8 weeks prior to enrolment.
- Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency and/or significant abnormal liver function, including patients with Alanine transaminase (ALT) and/or Aspartate transaminase (AST) ≥3x ULN (Upper Limit of Normal)and/or Total Bilirubin ≥2.0x ULN. History of severe hepatobiliary disease or hepatotoxicity with any medication. Positive serologic evidence of current infectious liver disease, including patients who are known to be positive for Hepatitis viral antibody ImmunoglobulinM (IgM), Hepatitis B surface antigen, and Hepatitis C virus antibody.
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 |
|---|---|---|
| DapagliflozinAlso: Forxiga5mg, orally, Green, plain, diamond-shaped, film-coated tablet | Drug | Dapagliflozin+Saxagliptin placebo+Metformin, Saxagliptin+Dapagliflozin+Metformin |
| Placebo for DapagliflozinDoes not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet | Drug | Saxagliptin+Dapagliflozin placebo+metformin |
| SaxagliptinAlso: Onglyza™5mg, orally, Plain, yellow, biconvex, round, film-coated tablet | Drug | Saxagliptin+Dapagliflozin placebo+metformin, Saxagliptin+Dapagliflozin+Metformin |
| Placebo for SaxagliptinDoes not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet | Drug | Dapagliflozin+Saxagliptin placebo+Metformin |
Primary outcome
Change From Baseline in HbA1c at Week 24
Time frame: Baseline and week 24
To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set. Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication.
3 secondary outcomes
Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks
Time frame: Baseline and week 24
Change in Fasting Plasma Glucose at 24 Weeks
Time frame: Baseline and week 24
Change in Total Body Weight at 24 Weeks
Time frame: Baseline and week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- d1683c00005 csp RedactedLink provided by the sponsor.
- D1683C00005 SAP redactedLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
110 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 Dapagliflozin and Saxagliptin in people with Type 2 Diabetes Mellitus and Inadequate Glycaemic Control, run by AstraZeneca at 110 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 7 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, Russia, Germany, Canada, Czechia 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 10 Oct 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?
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?
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 10 Oct 2018; AzTrials last refreshed its copy on 29 Oct 2026.