Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 127
Updated:1/10/2019
Start Date:September 6, 2014
End Date:August 29, 2016

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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

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.


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
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