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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Exenatide matching placebo; Drug: Exenatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02229383

D5553C00002

2014-003502-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 464 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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464 participants in 2 patient groups, including a placebo group

Exenatide

Experimental group

Description:

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

Treatment:

Drug: Exenatide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Exenatide matching placebo