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4B Study: Exenatide vs Insulin Lispro in T2DM

NCT00960661Phase 3

Key facts

Status: Completed
Start: Sep 2009
Primary completion: Aug 2012
Countries: 18
Sponsor: AstraZeneca
Modality: Peptides

Drugs: exenatide
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 3, randomised, open-label trial of exenatide in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by AstraZeneca. Primary endpoint: Change in Glycosylated Hemoglobin (HbA1c) at 30 weeks. Started Sep 2009; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Exenatide Arm
Exenatide 5-10mcg BID + Insulin Glargine + Metformin
Insulin Lispro Arm
Insulin Lispro TID + Insulin Glargine + Metformin

Who it enrols

Patients with Type 2 Diabetes Mellitus, BMI 25-45 kg/m2, and HbA1c 7.0-10.0% who have been taking basal insulin Glargine (>= 20 units/day) with Metformin (with or without Sulfonylurea) for at least 3 months.

Endpoints

Primary

Change in Glycosylated Hemoglobin (HbA1c)30 weeks

Secondary

Percentage of Participants Achieving HbA1C < 7.0%30 weeks
Percent of Participants Achieving HbA1c <= 6.5%30 weeks
Change in Fasting Blood Glucose30 weeks
Change in Body Weight30 weeks
Major and Minor Hypoglycemia Rate Per Year30 weeks
Change in Total Cholesterol, HDL, LDL30 weeks
Change in Systolic and Diastolic Blood Pressure30 weeks
Daily Insulin Glargine Dose30 weeks

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