Phase 3 · Exenatide

NCT02229396 trial results

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...

Change in HbA1c From Baseline to Week 28 (% HbA1c), Baseline to Week 28. Dapagliflozin + Placebo: -1.39; Exenatide + Dapagliflozin: -1.98; Exenatide + Placebo: -1.60.

Participants: 695
Status: completed
Completed: 2017-12-28
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT02229396), updated at source Dec 31, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02229396 measured first

Change in HbA1c From Baseline to Week 28% HbA1c · Baseline to Week 28 · least squares mean

Dapagliflozin + Placebon=230	Exenatide + Dapagliflozinn=228	Exenatide + Placebon=227
-1.39(-1.57 to -1.21)	-1.98(-2.16 to -1.79)	-1.60(-1.79 to -1.41)

Side effects by arm

Side effects in NCT02229396

Percent of participants affected, From baseline (Day 1) up to Week 104 (28-week Treatment Period + 24-week Extension Period 1 + 52-week Extension Period 2).. The most common events the registry lists.

Event	Dapagliflozin + Placebo	Exenatide + Dapagliflozin	Exenatide + Placebo
Any serious event	7.7%	7.4%	7.8%
Nausea	4.3%	5.6%	11.3%
Upper respiratory tract infection	9.4%	6.5%	7.4%
Injection site nodule	5.6%	8.7%	6.1%
Urinary tract infection	6.9%	8.2%	6.5%
Diarrhoea	4.7%	5.6%	7.4%
Headache	5.2%	6.9%	5.2%
Nasopharyngitis	5.2%	6.5%	3.5%
Vomiting	3%	3.5%	5.2%

Secondary outcomes

What else it measured

Change in Body Weight From Baseline to Week 28kilogram · Baseline to Week 28 · least squares mean

Dapagliflozin + Placebon=230	Exenatide + Dapagliflozinn=228	Exenatide + Placebon=227
-2.22(-2.78 to -1.66)	-3.55(-4.12 to -2.99)	-1.56(-2.13 to -0.98)

Change in Fasting Plasma Glucose From Baseline to Week 28milligrams/deciliter (mg/dL) · Baseline to Week 28 · least squares mean

Dapagliflozin + Placebon=230	Exenatide + Dapagliflozinn=228	Exenatide + Placebon=227
-49.19(-54.91 to -43.47)	-65.83(-71.60 to -60.06)	-45.75(-51.67 to -39.83)

Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Testmg/dL · Baseline to Week 28 · least squares mean

Dapagliflozin + Placebon=230	Exenatide + Dapagliflozinn=228	Exenatide + Placebon=227
-61.05(-69.10 to -53.00)	-87.83(-95.83 to -79.84)	-60.09(-68.48 to -51.71)

Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28% of patients · Baseline to Week 28 · number

Dapagliflozin + Placebon=230	Exenatide + Dapagliflozinn=228	Exenatide + Placebon=227
20.0(14.8 to 25.2)	33.3(27.2 to 39.5)	13.7(9.2 to 18.1)

Change in Fasting Plasma Glucose From Baseline to Week 2mg/dL · Baseline to Week 2 · least squares mean

Dapagliflozin + Placebon=230	Exenatide + Dapagliflozinn=228	Exenatide + Placebon=227
-26.31(-31.42 to -21.20)	-41.34(-46.48 to -36.20)	-21.08(-26.29 to -15.86)

Percentage of Patients Achieving HbA1c <7% at Week 28% of patients · Baseline to Week 28 · number

Dapagliflozin + Placebon=230	Exenatide + Dapagliflozinn=228	Exenatide + Placebon=227
19.1(14.1 to 24.2)	44.7(38.3 to 51.2)	26.9(21.1 to 32.6)

Change in Systolic Blood Pressure From Baseline to Week 28millimeters of mercury (mmHg) · Baseline to Week 28 · least squares mean

Dapagliflozin + Placebon=230	Exenatide + Dapagliflozinn=228	Exenatide + Placebon=227
-1.8(-3.4 to -0.3)	-4.3(-5.8 to -2.7)	-1.2(-2.8 to 0.4)

The trial

How NCT02229396 was run

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.

Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
Exenatide Once Weekly 2 mg Alone
Dapagliflozin Once Daily 10 mg Alone

Who could join the trial

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.

Published papers

Papers from NCT02229396

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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