Phase 3
Completed N=695
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
Source: ClinicalTrials.gov NCT02229396 ↗Enrolled (actual)
695
Serious AEs
7.6%
Results posted
Sep 2017
Primary outcomePrimary: Change in HbA1c From Baseline to Week 28 — -1.39; -1.98; -1.60 % HbA1c — p=0.003
◆ Published Evidence
Highly cited
389citations · ~39 / year
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.
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 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
Linked Publications (4)
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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.
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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.
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Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial.
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Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 28 |
-1.39; -1.98; -1.60 | 0.003 sig |
| SECONDARY Change in Body Weight From Baseline to Week 28 |
-2.22; -3.55; -1.56 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose From Baseline to Week 28 |
-49.19; -65.83; -45.75 | <0.001 sig |
| SECONDARY Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test |
-61.05; -87.83; -60.09 | <0.001 sig |
| SECONDARY Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28 |
20.0; 33.3; 13.7 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose From Baseline to Week 2 |
-26.31; -41.34; -21.08 | <0.001 sig |
| SECONDARY Percentage of Patients Achieving HbA1c <7% at Week 28 |
19.1; 44.7; 26.9 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Week 28 |
-1.8; -4.3; -1.2 | 0.005 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02229396) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.