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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
exenatide
insulin glargine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring diabetes, exenatide, insulin glargine, Lilly, Amylin

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2006
Last Updated
March 19, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00360334
Brief Title
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
diabetes, exenatide, insulin glargine, Lilly, Amylin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection, 5mcg or 10mcg, twice a day
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Other Intervention Name(s)
Lantus
Intervention Description
subcutaneous injection, titrated to target blood glucose level, once a day
Primary Outcome Measure Information:
Title
Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
Description
Composite endpoint evaluating effect of treatment on glycemic control and weight
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
Description
Composite endpoint evaluating effect of treatment on glycemic control and weight
Time Frame
26 weeks
Title
Change in Fasting Serum Glucose
Description
Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
Time Frame
26 weeks
Title
Percent of Patients Achieving HbA1c ≤ 7.4%
Description
Percent of patients achieving specified HbA1c target at endpoint
Time Frame
26 weeks
Title
Percent of Patients Achieving HbA1c < 7%
Description
Percent of patients achieving specified HbA1c target at endpoint
Time Frame
26 weeks
Title
Percent of Patients Achieving HbA1c < 6.5%
Description
Percent of patients achieving specified HbA1c target at endpoint
Time Frame
26 weeks
Title
Change in 7 Point Self Monitored Blood Glucose Profile
Description
Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
Time Frame
26 weeks
Title
Change in Body Mass Index (BMI)
Description
Change in BMI from baseline to endpoint
Time Frame
26 weeks
Title
Change in Waist Circumference
Description
Change in waist circumference from baseline to endpoint
Time Frame
26 Weeks
Title
Change in Waist-to-hip Ratio
Description
Change in waist-to-hip ratio from baseline to endpoint
Time Frame
26 weeks
Title
Change in Body Weight
Description
Change in body weight from baseline to endpoint
Time Frame
26 weeks
Title
Percent Change in Body Weight
Description
Percent change in baseline body weight at endpoint
Time Frame
26 Weeks
Title
Percent of Patients Achieving 5% Weight Loss
Description
Percent of patients who lost at least 5% of baseline body weight at endpoint
Time Frame
26 weeks
Title
Percent of Patients Achieving 10% Weight Loss
Description
Percent of patients who lost at least 10% of baseline body weight at endpoint
Time Frame
26 weeks
Title
Change in Systolic Blood Pressure
Description
Change in systolic blood pressure from baseline to endpoint
Time Frame
26 weeks
Title
Change in Diastolic Blood Pressure
Description
Change in diastolic blood pressure from baseline to endpoint
Time Frame
26 weeks
Title
Change in Fasting Serum Total Cholesterol (TC)
Description
Change in TC from baseline to endpoint
Time Frame
26 weeks
Title
Change in High Density Lipoprotein (HDL) Cholesterol
Description
Change in HDL cholesterol from baseline to endpoint
Time Frame
26 weeks
Title
Change in TC to HDL Cholesterol Ratio
Description
Change in TC to HDL cholesterol ratio from baseline to endpoint
Time Frame
26 weeks
Title
Change in Fasting Serum Triglycerides
Description
Change in fasting serum triglycerides from baseline to endpoint
Time Frame
26 weeks
Title
Change in Low Density Lipoprotein (LDL) Cholesterol
Description
Change in LDL cholesterol from baseline to endpoint
Time Frame
26 weeks
Title
Change in Apolipoprotein-B
Description
Change in apolipoprotein-B from baseline to endpoint
Time Frame
26 weeks
Title
Incidence of Hypoglycemic Episodes
Description
Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study
Time Frame
26 weeks
Title
Incidence of Nocturnal Hypoglycemic Episodes
Description
Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study
Time Frame
26 weeks
Title
Incidence of Severe Hypoglycemic Episodes
Description
Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study
Time Frame
26 weeks
Title
Hypoglycemic Rate Per 30 Days
Description
Number of hypoglycemic episodes per patient adjusted per 30 days
Time Frame
26 weeks
Title
Nocturnal Hypoglycemic Rate Per 30 Days
Description
Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days
Time Frame
26 weeks
Title
Severe Hypoglycemic Rate Per 30 Days
Description
Number of severe hypoglycemic episodes per patient adjusted per 30 days
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Silva de Lima, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aberdeen
Country
United Kingdom
Facility Name
Research Site
City
Bath
Country
United Kingdom
Facility Name
Research Site
City
Blackburn
Country
United Kingdom
Facility Name
Research Site
City
Bolton
Country
United Kingdom
Facility Name
Research Site
City
Bournemouth
Country
United Kingdom
Facility Name
Research Site
City
Bristol
Country
United Kingdom
Facility Name
Research Site
City
Chippenham
Country
United Kingdom
Facility Name
Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Haywards Heath
Country
United Kingdom
Facility Name
Research Site
City
High Wycombe
Country
United Kingdom
Facility Name
Research Site
City
Hull
Country
United Kingdom
Facility Name
Research Site
City
Ipswich
Country
United Kingdom
Facility Name
Research Site
City
Kent
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
Country
United Kingdom
Facility Name
Research Site
City
Livingstone
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Middlesborough
Country
United Kingdom
Facility Name
Research Site
City
Norwich
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
Country
United Kingdom
Facility Name
Research Site
City
Oldham
Country
United Kingdom
Facility Name
Research Site
City
Oxford
Country
United Kingdom
Facility Name
Research Site
City
Plymouth
Country
United Kingdom
Facility Name
Research Site
City
Rochdale
Country
United Kingdom
Facility Name
Research Site
City
Salford
Country
United Kingdom
Facility Name
Research Site
City
Swansea
Country
United Kingdom
Facility Name
Research Site
City
Torquay
Country
United Kingdom
Facility Name
Research Site
City
Wakefield
Country
United Kingdom
Facility Name
Research Site
City
Wirral
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19930005
Citation
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 with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009 Dec;11(12):1153-62. doi: 10.1111/j.1463-1326.2009.01154.x.
Results Reference
result
PubMed Identifier
22913891
Citation
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
Results Reference
derived

Learn more about this trial

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

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