A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

AstraZeneca235 enrolled

Overview

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

235

Conditions

Type 2 Diabetes

Interventions

exenatideDRUG

subcutaneous injection, 5mcg or 10mcg, twice a day

insulin glargineDRUG

subcutaneous injection, titrated to target blood glucose level, once a day

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with type 2 diabetes * Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months. * HbA1c between 7.5% and 10.0%. * BMI \>27. Exclusion Criteria: * Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study. * Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study. * Treatment with the following medications: \*Insulin as outpatient therapy within last 3 months; \*Meglitinides, or acarbose within the last 3 months; \*Regular use of any drugs that directly affect gastrointestinal motility; \*Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; \*Anti-obesity agent use within the last 3 months. * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Locations (31)

Research Site

Aberdeen, United Kingdom

Outcomes

Primary Outcomes

Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)

Composite endpoint evaluating effect of treatment on glycemic control and weight

Time frame: 26 weeks

Secondary Outcomes

Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg

Composite endpoint evaluating effect of treatment on glycemic control and weight

Time frame: 26 weeks

Change in Fasting Serum Glucose

Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)

Time frame: 26 weeks

Percent of Patients Achieving HbA1c ≤ 7.4%

Percent of patients achieving specified HbA1c target at endpoint

Time frame: 26 weeks

Percent of Patients Achieving HbA1c < 7%

Percent of patients achieving specified HbA1c target at endpoint

Time frame: 26 weeks

Percent of Patients Achieving HbA1c < 6.5%

Percent of patients achieving specified HbA1c target at endpoint

Time frame: 26 weeks

Change in 7 Point Self Monitored Blood Glucose Profile

Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day

Time frame: 26 weeks

Change in Body Mass Index (BMI)

Change in BMI from baseline to endpoint

Data from ClinicalTrials.gov

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Research Site

Bath, United Kingdom

Research Site

Blackburn, United Kingdom

Research Site

Bolton, United Kingdom

Research Site

Bournemouth, United Kingdom

Research Site

Bristol, United Kingdom

Research Site

Chippenham, United Kingdom

Research Site

Edinburgh, United Kingdom

Research Site

Glasgow, United Kingdom

Research Site

Haywards Heath, United Kingdom

...and 21 more locations

Time frame: 26 weeks

Change in Waist Circumference

Change in waist circumference from baseline to endpoint

Time frame: 26 Weeks

Change in Waist-to-hip Ratio

Change in waist-to-hip ratio from baseline to endpoint

Time frame: 26 weeks

Change in Body Weight

Change in body weight from baseline to endpoint

Time frame: 26 weeks

Percent Change in Body Weight

Percent change in baseline body weight at endpoint

Time frame: 26 Weeks

Percent of Patients Achieving 5% Weight Loss

Percent of patients who lost at least 5% of baseline body weight at endpoint

Time frame: 26 weeks

Percent of Patients Achieving 10% Weight Loss

Percent of patients who lost at least 10% of baseline body weight at endpoint

Time frame: 26 weeks

Change in Systolic Blood Pressure

Change in systolic blood pressure from baseline to endpoint

Time frame: 26 weeks

Change in Diastolic Blood Pressure

Change in diastolic blood pressure from baseline to endpoint

Time frame: 26 weeks

Change in Fasting Serum Total Cholesterol (TC)

Change in TC from baseline to endpoint

Time frame: 26 weeks

Change in High Density Lipoprotein (HDL) Cholesterol

Change in HDL cholesterol from baseline to endpoint

Time frame: 26 weeks

Change in TC to HDL Cholesterol Ratio

Change in TC to HDL cholesterol ratio from baseline to endpoint

Time frame: 26 weeks

Change in Fasting Serum Triglycerides

Change in fasting serum triglycerides from baseline to endpoint

Time frame: 26 weeks

Change in Low Density Lipoprotein (LDL) Cholesterol

Change in LDL cholesterol from baseline to endpoint

Time frame: 26 weeks

Change in Apolipoprotein-B

Change in apolipoprotein-B from baseline to endpoint

Time frame: 26 weeks

Incidence of Hypoglycemic Episodes

Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study

Time frame: 26 weeks

Incidence of Nocturnal Hypoglycemic Episodes

Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study

Time frame: 26 weeks

Incidence of Severe Hypoglycemic Episodes

Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study

Time frame: 26 weeks

Hypoglycemic Rate Per 30 Days

Number of hypoglycemic episodes per patient adjusted per 30 days

Time frame: 26 weeks

Nocturnal Hypoglycemic Rate Per 30 Days

Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days

Time frame: 26 weeks

Severe Hypoglycemic Rate Per 30 Days

Number of severe hypoglycemic episodes per patient adjusted per 30 days

Time frame: 26 weeks