Phase 3 · Exenatide

NCT02229383 trial results

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin

Change in HbA1c From Baseline to Week 28 (Percentage of HbA1c), Baseline to Week 28. Exenatide: -0.96; Placebo: -0.22.

Participants: 464
Status: completed
Completed: 2016-08-29
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT02229383), updated at source Jan 8, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02229383 measured first

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

Exenatiden=230	Placebon=228
-0.96(-1.12 to -0.81)	-0.22(-0.38 to -0.07)

Side effects by arm

Side effects in NCT02229383

Percent of participants affected, From Baseline (Day 1) up to Week 28. The most common events the registry lists.

Event	Exenatide	Placebo
Any serious event	4.8%	4.8%
Urinary tract infection	7.8%	6.6%
Blood creatine phosphokinase increased	2.2%	5.7%
Nausea	5.2%	3.9%
Injection site nodule	5.2%	0.4%

Secondary outcomes

What else it measured

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

Exenatiden=230	Placebon=228
-1.04(-1.54 to -0.53)	0.48(-0.02 to 0.98)

Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)milligram per deciliter · Baseline to Week 28 · least squares mean

Exenatiden=230	Placebon=228
-28.73(-40.0 to -17.45)	-0.96(-12.41 to 10.48)

Percentage of Participants Achieving HbA1c <7.0% at Week 28Percentage of participants · Baseline to Week 28 · number

Exenatiden=230	Placebon=228
32.6(26.6 to 38.7)	7.0(3.7 to 10.3)

Change From Baseline to Week 28 in Daily Insulin DoseUnits · Baseline to Week 28 · least squares mean

Exenatiden=230	Placebon=228
1.6(0.1 to 3.1)	3.5(2.0 to 5.1)

Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 WeeksPercentage of participants · Baseline to Week 28 · number

Exenatiden=230	Placebon=228
22.2(16.8 to 27.5)	2.2(0.3 to 4.1)

Change in Seated Systolic Blood Pressure From Baseline to Week 28millimeter of mercury · Baseline to Week 28 · least squares mean

Exenatiden=230	Placebon=228
-2.5(-4.4 to -0.7)	-0.7(-2.6 to 1.1)

The trial

How NCT02229383 was run

Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.

Exenatide: Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
Placebo: Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin

Who could join the trial

Inclusion criteria: * Has a diagnosis of Type 2 Diabetes Mellitus (T2DM) * Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening). * Has fasting plasma glucose (FPG) concentration \<280 mg/dL (15.6 mmol/L) at Visit 1 (Screening) * Treated with basal insulin glargine at a dose of ≥20 units/day once daily for at least 6 weeks prior to Screening, in combination with diet and exercise alone or in combination with: 1. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 2. a stable dose of metformin (≥1500 mg/day) for at least 8 weeks prior to Visit 1 (Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the Screening visit Exclusion criteria: * Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening) * History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1 * Positive serological test for hepatitis B or hepatitis C

Published papers

Papers from NCT02229383

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

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