Primary outcomeLeast squares mean· Baseline to Week 28
Change in HbA1c From Baseline to Week 28
| Group | Value (% HbA1c) |
|---|---|
| Dapagliflozin + Placebo | -1.39 |
| Exenatide + Dapagliflozin | -1.98 |
| Exenatide + Placebo | -1.60 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataPhase 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
NCTNCT02229396 (opens ClinicalTrials.gov in a new tab)Other idD5553C00003Other id2014-003503-29Other id2014
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 695 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Double masking
- Countries
6 countries
United States, Hungary, Poland, Romania, Slovakia, South Africa
- Start
- 4 Sept 2014
- Primary completion
- 26 Apr 2016
- Completion
- 28 Dec 2017
- First posted
- 1 Sept 2014 (estimated)
- Last update posted
- 31 Dec 2018
- Conditions
- Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20142015201620172018
- Ph 3
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
NCT022293964 Sept 2014 to 28 Dec 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
Interventions
- Exantide with DapagliflozinDrug
- ExentideDrug
- DapagliflozinDrug
Arms3
Experimental
Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
Experimental
Exenatide Once Weekly 2 mg Alone
Active comparator
Dapagliflozin Once Daily 10 mg Alone
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
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.
Secondary outcomes(7)
Change in Body Weight From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
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.
Change in Fasting Plasma Glucose From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
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.
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
Time frame · Baseline to Week 28
Registry description
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.
Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28
Time frame · Baseline to Week 28
Registry description
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.
Change in Fasting Plasma Glucose From Baseline to Week 2
Time frame · Baseline to Week 2
Registry description
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.
Percentage of Patients Achieving HbA1c <7% at Week 28
Time frame · Baseline to Week 28
Registry description
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.
Change in Systolic Blood Pressure From Baseline to Week 28
Time frame · Baseline to Week 28
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline to Week 28
Change in Body Weight From Baseline to Week 28
| Group | Value (kilogram) |
|---|---|
| Dapagliflozin + Placebo | -2.22 |
| Exenatide + Dapagliflozin | -3.55 |
| Exenatide + Placebo | -1.56 |
Secondary outcomeLeast squares mean· Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 28
| Group | Value (milligrams/deciliter (mg/dL)) |
|---|---|
| Dapagliflozin + Placebo | -49.19 |
| Exenatide + Dapagliflozin | -65.83 |
| Exenatide + Placebo | -45.75 |
Secondary outcomeLeast squares mean· Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
| Group | Value (mg/dL) |
|---|---|
| Dapagliflozin + Placebo | -61.05 |
| Exenatide + Dapagliflozin | -87.83 |
| Exenatide + Placebo | -60.09 |
Secondary outcomeNumber· Baseline to Week 28
Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28
| Group | Value (% of patients) |
|---|---|
| Dapagliflozin + Placebo | 20.0 |
| Exenatide + Dapagliflozin | 33.3 |
| Exenatide + Placebo | 13.7 |
Secondary outcomeLeast squares mean· Baseline to Week 2
Change in Fasting Plasma Glucose From Baseline to Week 2
| Group | Value (mg/dL) |
|---|---|
| Dapagliflozin + Placebo | -26.31 |
| Exenatide + Dapagliflozin | -41.34 |
| Exenatide + Placebo | -21.08 |
Secondary outcomeNumber· Baseline to Week 28
Percentage of Patients Achieving HbA1c <7% at Week 28
| Group | Value (% of patients) |
|---|---|
| Dapagliflozin + Placebo | 19.1 |
| Exenatide + Dapagliflozin | 44.7 |
| Exenatide + Placebo | 26.9 |
Secondary outcomeLeast squares mean· Baseline to Week 28
Change in Systolic Blood Pressure From Baseline to Week 28
| Group | Value (millimeters of mercury (mmHg)) |
|---|---|
| Dapagliflozin + Placebo | -1.8 |
| Exenatide + Dapagliflozin | -4.3 |
| Exenatide + Placebo | -1.2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Dapagliflozin + PlaceboDapagliflozin 10 mg tablet administered orally once daily + matching placebo for exenatide administered as SC injection once weekly. Patients continued to administer the same type and dose of metformin therapy they were using at study entry. | 2 / 233 | 18 / 233 | 73 / 233 |
| Exenatide + DapagliflozinExenatide once weekly (EQW) 2 mg administered as SC injection + dapagliflozin 10 mg tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry. | 3 / 231 | 17 / 231 | 87 / 231 |
| Exenatide + PlaceboExenatide once weekly (EQW) 2 mg administered as SC injection + matching placebo for dapagliflozin tablet administered orally once daily. Patients continued to administer the same type and dose of metformin therapy they were using at study entry. | 1 / 230 | 18 / 230 | 78 / 230 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies4
Studies that cite this trial.
Studies with results
2 studies on this page
Indexing hint: Randomized controlled trial · 2020
5 results
Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial.
Jabbour et al. 2020Diabetes carecited by 51
PMID 32816874PMC7510043DOI 10.2337/dc19-1350PUB-32816874
Rights unknown5 results
Indexing hint: Randomized controlled trial · 2018
12 results
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.
Jabbour et al. 2018Diabetes carecited by 81
PMID 30082326PMC6150435DOI 10.2337/dc18-0680PUB-30082326
Rights unknown12 results
More studies
2 studies on this page
PubMed tag: none · 2020
Corrected
Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.
Guja et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 6
PMID 32306296PMC7324446DOI 10.1007/s13300-020-00815-zPUB-32306296
Free to read · publisher termsCC BY-NC
Indexing hint: Randomized controlled trial · 2016
Corrected
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.
Frías et al. 2016The lancet. Diabetes & endocrinologycited by 322
PMID 27651331DOI 10.1016/s2213-8587(16)30267-4PUB-27651331
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 130 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria
* 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.
Exclusion criteria
* 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.
PepBank is a research reference. Talk to a doctor before you use any peptide.