Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

AstraZeneca427 enrolled

Overview

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

427

Conditions

Type 2 Diabetes Mellitus

Interventions

exenatide once weeklyDRUG

subcutaneous injection, 2.0mg, once a week;

insulin glargineDRUG

subcutaneous injection, titrated to achieve fasting serum glucose target, once a day

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * present with type 2 diabetes mellitus * HbA1c between 7.1% and 11.0% inclusive * body mass index (BMI) of \>18kg/m2 and \<35kg/m2, inclusive * treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start Exclusion Criteria: * Have received chronic (\>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start. * Have been treated with drugs that promote weight loss within 90 days prior to study start. * Have been treated with drugs that directly affect gastrointestinal motility for \> 21 consecutive days within 90 days prior to study start. * Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered). * Have been treated for \>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs * Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication. * Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start. * Have donated blood within 30 days prior to study start.

Locations (22)

Research Site

Aomori, Japan

Research Site

Chiba, Japan

Research Site

Ehime, Japan

Outcomes

Primary Outcomes

Change in HbA1c From Baseline to Endpoint (Week 26)

Change in HbA1c from baseline to endpoint (Week 26).

Time frame: Baseline, Week 26

Secondary Outcomes

Percentage of Subjects Achieving HbA1c<=7%

Percentage of subjects achieving HbA1c \<=7.0% (for subjects with HbA1c \>7% at baseline)

Time frame: Baseline, Week 26

Percentage of Subjects Achieving HbA1c<=6.5%

Percentage of subjects achieving HbA1c \<=6.5% (for subjects with HbA1c \>6.5% at baseline)

Time frame: Baseline, Week 26

Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)

Change in FSG (centralized measurement) from baseline to endpoint (Week 26)

Time frame: Baseline, Week 26

Change in Body Weight From Baseline to Endpoint (Week 26)

Change in Body Weight from baseline to endpoint (Week 26)

Time frame: Baseline, Week 26

Change in Total Cholesterol From Baseline to Endpoint (Week 26)

Change in Total Cholesterol from baseline to endpoint (Week 26)

Time frame: Baseline, Week 26

Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)

Change in HDL-C from baseline to endpoint (Week 26)

Time frame: Baseline, Week 26

Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline

Data from ClinicalTrials.gov

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