Diabetes MellitusPhase 3NCT02229396

Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

A Phase 3 study testing Exantide with Dapagliflozin, Exentide and Dapagliflozin in people with Diabetes Mellitus, run by AstraZeneca at 133 sites in 6 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

Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10… Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Exantide with Dapagliflozin, Exentide and Dapagliflozin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 695 participants
Where: 133 sitesin 6 countries
Study dates: 4 Sep 2014to 28 Dec 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

Has a diagnosis of T2DM.
Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.
Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.

Who cannot join

FPG ≥280 mg/dL (15.6 mmol/L).
Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator.
Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded.
Known active proliferative retinopathy.
History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.

Trial locations and contacts

133 sites in 6 countries.

Country

City, postcode or hospital

133 sites in 6 countries

United States76 sites

Research Site
Anaheim, California, 92801
Research Site
Avon, Indiana, 46123
Research Site
Bellevue, Nebraska, 68005
Research Site
Birmingham, Alabama, 35235
Research Site
Boynton Beach, Florida, 33437
Research Site
Burke, Virginia, 22015
Research Site
Burlington, North Carolina, 27215
Research Site
Charleston, South Carolina, 29407
Research Site
Chicago, Illinois, 60607
Research Site
Chula Vista, California, 91911
Research Site
Cincinnati, Ohio, 45242
Research Site
Clearwater, Florida, 33765
Research Site
Clinton, Utah, 84015
Research Site
Coral Gables, Florida, 33134
Research Site
Dakota Dunes, South Dakota, 57049
Research Site
Dallas, Texas, 75218
Research Site
Dallas, Texas, 75230
Research Site
El Cajon, California, 92020
Research Site
Evansville, Indiana, 47714
Research Site
Fort Lauderdale, Florida, 33316
Research Site
Franklin, Indiana, 46131
Research Site
Fresno, California, 93720
Research Site
Glendale, Arizona, 85306
Research Site
Greensboro, North Carolina, 27408
Research Site
Greer, South Carolina, 29651
Research Site
Haddon Heights, New Jersey, 08035
Research Site
Hazelwood, Missouri, 63042
Research Site
Hialeah, Florida, 33012
Research Site
Houston, Texas, 77074
Research Site
Houston, Texas, 77079
Research Site
Houston, Texas, 77090
Research Site
Huntsville, Alabama, 35801
Research Site
Jacksonville, Florida, 32256
Research Site
Jacksonville, Florida, 32277
Research Site
La Mesa, California, 91942
Research Site
Las Vegas, Nevada, 89109
Research Site
Long Beach, California, 90807
Research Site
Los Angeles, California, 90057
Research Site
Manassas, Virginia, 20110
Research Site
Medford, Oregon, 97504
Research Site
Memphis, Tennessee, 38119
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33133
Research Site
Miami, Florida, 33135
Research Site
Miami, Florida, 33142
Research Site
Miami, Florida, 33165
Research Site
Miami, Florida, 33175
Research Site
Miami, Florida, 33186
Research Site
Mission Hills, California, 91345
Research Site
Monroe, Louisiana, 71201
Research Site
Montclair, California, 91763
Research Site
Mooresville, North Carolina, 28117
Research Site
Morehead City, North Carolina, 28557
Research Site
Muncie, Indiana, 47304
Research Site
Newton, Kansas, 67114
Research Site
North Miami Beach, Florida, 33162
Research Site
Oceanside, California, 92056
Research Site
Orlando, Florida, 32801
Research Site
Orlando, Florida, 32806
Research Site
Pearland, Texas, 77584
Research Site
Philadelphia, Pennsylvania, 91307
Research Site
Richmond, Virginia, 23294
Research Site
Salt Lake City, Utah, 84102
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92103
Research Site
San Diego, California, 92114
Research Site
Spartanburg, South Carolina, 29303
Research Site
Summerville, South Carolina, 29485
Research Site
Tampa, Florida, 33603
Research Site
Tempe, Arizona, 85283
Research Site
Tomball, Texas, 77375
Research Site
Tuscumbia, Alabama, 35674
Research Site
Tustin, California, 92780
Research Site
Van Nuys, California, 91405
Research Site
Vandalia, Ohio, 45377
Research Site
Williston, Florida, 32696

Other trials in United States

Hungary17 sites

Research Site
Baja, 6500
Research Site
Balatonfüred, 8230
Research Site
Budaörs, 2040
Research Site
Budapest, 1033
Research Site
Budapest, 1083
Research Site
Budapest, 1088
Research Site
Debrecen, 4025
Research Site
Eger, 3300
Research Site
Gödöllő, 2100
Research Site
Gyula, 5700
Research Site
Kecskemét, 6000
Research Site
Komárom, 2921
Research Site
Létavértes, 4281
Research Site
Nyíregyháza, 4405
Research Site
Pécs, 7623
Research Site
Szeged, 6722
Research Site
Szekszárd, 7100

Other trials in Hungary

Slovakia14 sites

Research Site
Banská Bystrica, 97517
Research Site
Bardejov, 085 01
Research Site
Bratislava, 81108
Research Site
Bratislava, 82106
Research Site
Bratislava, 85101
Research Site
Dolný Kubín, 026 01
Research Site
Košice, 04001
Research Site
Levice, 934 01
Research Site
Levice, 93401
Research Site
Lučenec, 984 01
Research Site
Nitra, 94911
Research Site
Pezinok, 90201
Research Site
Štúrovo, 943 01
Research Site
Trebišov, 07501

Other trials in Slovakia

Romania10 sites

Research Site
Baia Mare, 430222
Research Site
Bucharest, 010192
Research Site
Bucharest, 010825
Research Site
Bucharest, 020475
Research Site
Galati, 800578
Research Site
Oradea, 410032
Research Site
Oradea, 410169
Research Site
Oradea, 410469
Research Site
Ploieşti, 100342
Research Site
Timișoara, 300456

Other trials in Romania

Poland8 sites

Research Site
Lodz, 94-048
Research Site
Lodz, 94-255
Research Site
Lublin, 20-538
Research Site
Oświęcim, 32-600
Research Site
Parczew, 21-200
Research Site
Poznan, 61-655
Research Site
Torun, 87-100
Research Site
Zgierz, 95-100

Other trials in Poland

South Africa8 sites

Research Site
Bloemfontein, 9301
Research Site
Cape Town, 7925
Research Site
Johannesburg, 1818
Research Site
Kempton Park, 1619
Research Site
Middelburg, 1055
Research Site
Parow, 7505
Research Site
Port Elizabeth, 6014
Research Site
Pretoria, 0001

Other trials in South Africa

About this study

Official title: A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin

Conditions: Diabetes Mellitus
Being tested: Exantide with Dapagliflozin, Exentide, Dapagliflozin
Keywords: Diabetes Mellitus, Exenatide, Dapagliflozin, Diabetes medication, Treatment efficacy, Placebo, Metabolism, Cardiovascular metabolic
Medical subject headings: Diabetes Mellitus

What participants receive

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

Exantide with DapagliflozinDrug
2 mg weekly suspension injection and 10 mg Dapagliflozin
ExentideDrug
2 mg
DapagliflozinDrug
10 mg once daily Dapagliflozin

Study groups in NCT02229396
Study group	Role	What they receive
Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg	Experimental	Not described Receives: Drug: Exantide with Dapagliflozin
Exenatide Once Weekly 2 mg Alone	Experimental	Not described Receives: Drug: Exentide
Dapagliflozin Once Daily 10 mg Alone	Active comparator	Not described Receives: Drug: Dapagliflozin

What is being measured

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

Change in HbA1c From Baseline to Week 28
To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Measured: Baseline to Week 28

Secondary outcomes (7)

Change in Body Weight From Baseline to Week 28
To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Measured: Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 28
To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Measured: Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Measured: Baseline to Week 28
Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28
To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Measured: Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 2
To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Measured: Baseline to Week 2
Percentage of Patients Achieving HbA1c <7% at Week 28
To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Measured: Baseline to Week 28
Change in Systolic Blood Pressure From Baseline to Week 28
To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Measured: Baseline to Week 28

Timeline

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

4 Sep 201428 Dec 2017

First posted1 Sep 2014 (estimated)
Study start4 Sep 2014
Primary completion26 Apr 2016
Study completion28 Dec 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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 695 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02229396
Sponsor's protocol ID: D5553C00003
Other IDs: 2014-003503-29, 2014
Status last verified: Dec 2018
First submitted: 28 Aug 2014
Last updated: 31 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jabbour SA, Frias JP, Ahmed A, Hardy E, Choi J, Sjostrom CD, Guja C. Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial. Diabetes Care. 2020 Oct;43(10):2528-2536. doi: 10.2337/dc19-1350. Epub 2020 Aug 18.
PubMed 32816874
Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
PubMed 32306296
Jabbour SA, Frias JP, Hardy E, Ahmed A, Wang H, Ohman P, Guja C. Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the DURATION-8 Randomized Controlled Trial. Diabetes Care. 2018 Oct;41(10):2136-2146. doi: 10.2337/dc18-0680. Epub 2018 Aug 6.
PubMed 30082326
Frias JP, Guja C, Hardy E, Ahmed A, Dong F, Ohman P, Jabbour SA. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Dec;4(12):1004-1016. doi: 10.1016/S2213-8587(16)30267-4. Epub 2016 Sep 16.
PubMed 27651331

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin
ClinicalTrials.gov ID: NCT02229396
Acronym / sponsor ID: D5553C00003
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, Exenatide, Dapagliflozin, Diabetes medication, Treatment efficacy, Placebo, Metabolism, Cardiovascular metabolic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 695 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 4 Sep 2014 (actual)
Primary completion: 26 Apr 2016 (actual)
Study completion: 28 Dec 2017 (actual)
First posted: 1 Sep 2014 (estimated)
Results: Posted 8 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg	Experimental	Drug: Exantide with Dapagliflozin
Exenatide Once Weekly 2 mg Alone	Experimental	Drug: Exentide
Dapagliflozin Once Daily 10 mg Alone	Active comparator	Drug: Dapagliflozin

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Has a diagnosis of T2DM.
Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.
Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.

Key exclusion criteria (8 listed)

FPG ≥280 mg/dL (15.6 mmol/L).
Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator.
Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded.
Known active proliferative retinopathy.

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
Exantide with Dapagliflozin2 mg weekly suspension injection and 10 mg Dapagliflozin	Drug	Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
Exentide2 mg	Drug	Exenatide Once Weekly 2 mg Alone
Dapagliflozin10 mg once daily Dapagliflozin	Drug	Dapagliflozin Once Daily 10 mg Alone

Primary outcome

Change in HbA1c From Baseline to Week 28
Time frame: Baseline to Week 28
To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

7 secondary outcomes

Change in Body Weight From Baseline to Week 28
Time frame: Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 28
Time frame: Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
Time frame: Baseline to Week 28
Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28
Time frame: Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 2
Time frame: Baseline to Week 2
Percentage of Patients Achieving HbA1c <7% at Week 28
Time frame: Baseline to Week 28
Change in Systolic Blood Pressure From Baseline to Week 28
Time frame: Baseline to Week 28

Results and safety

Results posted to the registry on 8 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin + Placebo	233	155
Exenatide + Dapagliflozin	231	154
Exenatide + Placebo	231	136

Primary outcome: Change in HbA1c From Baseline to Week 28

Time frame: Baseline to Week 28. Least squares mean (95% Confidence Interval). Unit: % HbA1c

Measure	Dapagliflozin + Placebo n = 230	Exenatide + Dapagliflozin n = 228	Exenatide + Placebo n = 227
Value	-1.39 (-1.57 to -1.21)	-1.98 (-2.16 to -1.79)	-1.60 (-1.79 to -1.41)

Exenatide + Dapagliflozin vs Exenatide + Placebo: Mean Difference (Final Values): -0.38 (95% CI -0.63 to -0.13), p = 0.003, Mixed Models Analysis
Dapagliflozin + Placebo vs Exenatide + Dapagliflozin: Mean Difference (Final Values): -0.59 (95% CI -0.84 to -0.34), p <0.001, Mixed Models Analysis

Population analysed: The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline (Day 1) up to Week 104 (28-week Treatment Period + 24-week Extension Period 1 + 52-week Extension Period 2).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin + Placebo	18 of 233 (7.7%)	73 of 233 (31.3%)	2 of 233
Exenatide + Dapagliflozin	17 of 231 (7.4%)	87 of 231 (37.7%)	3 of 231
Exenatide + Placebo	18 of 230 (7.8%)	78 of 230 (33.9%)	1 of 230

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32816874Jabbour SA, Frias JP, Ahmed A, Hardy E, Choi J, Sjostrom CD, Guja C. Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial. Diabetes Care. 2020 Oct;43(10):2528-2536. doi: 10.2337/dc19-1350. Epub 2020 Aug 18.
Derived from this study: PubMed 32306296Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
Derived from this study: PubMed 30082326Jabbour SA, Frias JP, Hardy E, Ahmed A, Wang H, Ohman P, Guja C. Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the DURATION-8 Randomized Controlled Trial. Diabetes Care. 2018 Oct;41(10):2136-2146. doi: 10.2337/dc18-0680. Epub 2018 Aug 6.
Derived from this study: PubMed 27651331Frias JP, Guja C, Hardy E, Ahmed A, Dong F, Ohman P, Jabbour SA. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Dec;4(12):1004-1016. doi: 10.1016/S2213-8587(16)30267-4. Epub 2016 Sep 16.
CSP\_radactedLink provided by the sponsor.

Related trials for Diabetes Mellitus

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes

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.

133 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 Exantide with Dapagliflozin, Exentide and Dapagliflozin in people with Diabetes Mellitus, run by AstraZeneca at 133 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 3 inclusion and 8 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 31 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 133 sites in United States, Hungary, Slovakia, Romania, Poland 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 8 Sep 2017). 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 in HbA1c From Baseline to Week 28 (time frame: Baseline to Week 28). 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 NCT02229396, 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 31 Dec 2018.