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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: exenatide; Drug: insulin glargine

• Registration Number: NCT00360334
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-08-02
• Study First Submitted QC: 2006-08-02
• Study First Posted: 2006-08-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-14
• Results First Submitted QC: 2009-04-14
• Results First Posted: 2009-06-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	exenatide	-
2	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)	26 weeks	Composite endpoint evaluating effect of treatment on glycemic control and weight

Secondary Outcome Measures

Name	Time	Method
Severe Hypoglycemic Rate Per 30 Days	26 weeks	Number of severe hypoglycemic episodes per patient adjusted per 30 days
Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg	26 weeks	Composite endpoint evaluating effect of treatment on glycemic control and weight
Change in Fasting Serum Glucose	26 weeks	Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
Percent of Patients Achieving HbA1c ≤ 7.4%	26 weeks	Percent of patients achieving specified HbA1c target at endpoint
Percent of Patients Achieving HbA1c < 7%	26 weeks	Percent of patients achieving specified HbA1c target at endpoint
Percent of Patients Achieving HbA1c < 6.5%	26 weeks	Percent of patients achieving specified HbA1c target at endpoint
Change in 7 Point Self Monitored Blood Glucose Profile	26 weeks	Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
Change in Body Mass Index (BMI)	26 weeks	Change in BMI from baseline to endpoint
Change in Waist Circumference	26 Weeks	Change in waist circumference from baseline to endpoint
Change in Waist-to-hip Ratio	26 weeks	Change in waist-to-hip ratio from baseline to endpoint
Change in Body Weight	26 weeks	Change in body weight from baseline to endpoint
Percent Change in Body Weight	26 Weeks	Percent change in baseline body weight at endpoint
Percent of Patients Achieving 5% Weight Loss	26 weeks	Percent of patients who lost at least 5% of baseline body weight at endpoint
Percent of Patients Achieving 10% Weight Loss	26 weeks	Percent of patients who lost at least 10% of baseline body weight at endpoint
Change in Systolic Blood Pressure	26 weeks	Change in systolic blood pressure from baseline to endpoint
Change in Diastolic Blood Pressure	26 weeks	Change in diastolic blood pressure from baseline to endpoint
Change in Fasting Serum Total Cholesterol (TC)	26 weeks	Change in TC from baseline to endpoint
Change in High Density Lipoprotein (HDL) Cholesterol	26 weeks	Change in HDL cholesterol from baseline to endpoint
Change in TC to HDL Cholesterol Ratio	26 weeks	Change in TC to HDL cholesterol ratio from baseline to endpoint
Change in Fasting Serum Triglycerides	26 weeks	Change in fasting serum triglycerides from baseline to endpoint
Change in Low Density Lipoprotein (LDL) Cholesterol	26 weeks	Change in LDL cholesterol from baseline to endpoint
Change in Apolipoprotein-B	26 weeks	Change in apolipoprotein-B from baseline to endpoint
Incidence of Hypoglycemic Episodes	26 weeks	Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study
Incidence of Nocturnal Hypoglycemic Episodes	26 weeks	Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study
Incidence of Severe Hypoglycemic Episodes	26 weeks	Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study
Hypoglycemic Rate Per 30 Days	26 weeks	Number of hypoglycemic episodes per patient adjusted per 30 days
Nocturnal Hypoglycemic Rate Per 30 Days	26 weeks	Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wirral, United Kingdom