Clinical trial NCT00360334: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: diabetes
exenatide
insulin glargine
Lilly
Amylin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2006-08-04
Enrollment: 235
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
timeFrame: 26 weeks
Secondary outcomes:
measure: Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
timeFrame: 26 weeks
measure: Change in Fasting Serum Glucose
timeFrame: 26 weeks
measure: Percent of Patients Achieving HbA1c ≤ 7.4%
timeFrame: 26 weeks
measure: Percent of Patients Achieving HbA1c < 7%
timeFrame: 26 weeks
measure: Percent of Patients Achieving HbA1c < 6.5%
timeFrame: 26 weeks
measure: Change in 7 Point Self Monitored Blood Glucose Profile
timeFrame: 26 weeks
measure: Change in Body Mass Index (BMI)
timeFrame: 26 weeks
measure: Change in Waist Circumference
timeFrame: 26 Weeks
measure: Change in Waist-to-hip Ratio
timeFrame: 26 weeks
measure: Change in Body Weight
timeFrame: 26 weeks
measure: Percent Change in Body Weight
timeFrame: 26 Weeks
measure: Percent of Patients Achieving 5% Weight Loss
timeFrame: 26 weeks
measure: Percent of Patients Achieving 10% Weight Loss
timeFrame: 26 weeks
measure: Change in Systolic Blood Pressure
timeFrame: 26 weeks
measure: Change in Diastolic Blood Pressure
timeFrame: 26 weeks
measure: Change in Fasting Serum Total Cholesterol (TC)
timeFrame: 26 weeks
measure: Change in High Density Lipoprotein (HDL) Cholesterol
timeFrame: 26 weeks
measure: Change in TC to HDL Cholesterol Ratio
timeFrame: 26 weeks
measure: Change in Fasting Serum Triglycerides
timeFrame: 26 weeks
measure: Change in Low Density Lipoprotein (LDL) Cholesterol
timeFrame: 26 weeks
measure: Change in Apolipoprotein-B
timeFrame: 26 weeks
measure: Incidence of Hypoglycemic Episodes
timeFrame: 26 weeks
measure: Incidence of Nocturnal Hypoglycemic Episodes
timeFrame: 26 weeks
measure: Incidence of Severe Hypoglycemic Episodes
timeFrame: 26 weeks
measure: Hypoglycemic Rate Per 30 Days
timeFrame: 26 weeks
measure: Nocturnal Hypoglycemic Rate Per 30 Days
timeFrame: 26 weeks
measure: Severe Hypoglycemic Rate Per 30 Days
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Blackburn
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Chippenham
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Haywards Heath
country: United Kingdom
facility: Research Site
city: High Wycombe
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Ipswich
country: United Kingdom
facility: Research Site
city: Kent
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Livingstone
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Middlesborough
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Oldham
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Rochdale
country: United Kingdom
facility: Research Site
city: Salford
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
city: Torquay
country: United Kingdom
facility: Research Site
city: Wakefield
country: United Kingdom
facility: Research Site
city: Wirral
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Mauricio Silva de Lima, MD
role: STUDY_DIRECTOR
References:
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.
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.