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

Type 2 Diabetes Clinical Trial

Official title:

An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360334
• Other study ID #: H8O-BP-GWBG
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2006
• Last updated: March 19, 2015
• Start date: June 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes
• Weight Gain

Intervention

Drug:
• exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
• insulin glargine
subcutaneous injection, titrated to target blood glucose level, once a day

Locations

Country	Name	City	State
United Kingdom	Research Site	Aberdeen
United Kingdom	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	Research Site	High Wycombe
United Kingdom	Research Site	Hull
United Kingdom	Research Site	Ipswich
United Kingdom	Research Site	Kent
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	Livingstone
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Middlesborough
United Kingdom	Research Site	Norwich
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Oldham
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Rochdale
United Kingdom	Research Site	Salford
United Kingdom	Research Site	Swansea
United Kingdom	Research Site	Torquay
United Kingdom	Research Site	Wakefield
United Kingdom	Research Site	Wirral

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients Who Achieved HbA1c = 7.4% With Minimal Weight Gain (= 1kg)	Composite endpoint evaluating effect of treatment on glycemic control and weight	26 weeks	No
Secondary	Percent of Patients Who Achieved HbA1c = 7.4% and Weight Gain = 0.5kg	Composite endpoint evaluating effect of treatment on glycemic control and weight	26 weeks	No
Secondary	Change in Fasting Serum Glucose	Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)	26 weeks	No
Secondary	Percent of Patients Achieving HbA1c = 7.4%	Percent of patients achieving specified HbA1c target at endpoint	26 weeks	No
Secondary	Percent of Patients Achieving HbA1c < 7%	Percent of patients achieving specified HbA1c target at endpoint	26 weeks	No
Secondary	Percent of Patients Achieving HbA1c < 6.5%	Percent of patients achieving specified HbA1c target at endpoint	26 weeks	No
Secondary	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	26 weeks	No
Secondary	Change in Body Mass Index (BMI)	Change in BMI from baseline to endpoint	26 weeks	No
Secondary	Change in Waist Circumference	Change in waist circumference from baseline to endpoint	26 Weeks	No
Secondary	Change in Waist-to-hip Ratio	Change in waist-to-hip ratio from baseline to endpoint	26 weeks	No
Secondary	Change in Body Weight	Change in body weight from baseline to endpoint	26 weeks	No
Secondary	Percent Change in Body Weight	Percent change in baseline body weight at endpoint	26 Weeks	No
Secondary	Percent of Patients Achieving 5% Weight Loss	Percent of patients who lost at least 5% of baseline body weight at endpoint	26 weeks	No
Secondary	Percent of Patients Achieving 10% Weight Loss	Percent of patients who lost at least 10% of baseline body weight at endpoint	26 weeks	No
Secondary	Change in Systolic Blood Pressure	Change in systolic blood pressure from baseline to endpoint	26 weeks	No
Secondary	Change in Diastolic Blood Pressure	Change in diastolic blood pressure from baseline to endpoint	26 weeks	No
Secondary	Change in Fasting Serum Total Cholesterol (TC)	Change in TC from baseline to endpoint	26 weeks	No
Secondary	Change in High Density Lipoprotein (HDL) Cholesterol	Change in HDL cholesterol from baseline to endpoint	26 weeks	No
Secondary	Change in TC to HDL Cholesterol Ratio	Change in TC to HDL cholesterol ratio from baseline to endpoint	26 weeks	No
Secondary	Change in Fasting Serum Triglycerides	Change in fasting serum triglycerides from baseline to endpoint	26 weeks	No
Secondary	Change in Low Density Lipoprotein (LDL) Cholesterol	Change in LDL cholesterol from baseline to endpoint	26 weeks	No
Secondary	Change in Apolipoprotein-B	Change in apolipoprotein-B from baseline to endpoint	26 weeks	No
Secondary	Incidence of Hypoglycemic Episodes	Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study	26 weeks	No
Secondary	Incidence of Nocturnal Hypoglycemic Episodes	Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study	26 weeks	No
Secondary	Incidence of Severe Hypoglycemic Episodes	Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study	26 weeks	No
Secondary	Hypoglycemic Rate Per 30 Days	Number of hypoglycemic episodes per patient adjusted per 30 days	26 weeks	No
Secondary	Nocturnal Hypoglycemic Rate Per 30 Days	Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days	26 weeks	No
Secondary	Severe Hypoglycemic Rate Per 30 Days	Number of severe hypoglycemic episodes per patient adjusted per 30 days	26 weeks	No