Status:
COMPLETED
Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported ...
Eligibility Criteria
Inclusion
- Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive
- Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
- Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start
Exclusion
- Have any contraindication for the OAD that they have been using
- Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
- Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
- Have been treated with drugs that promote weight loss, within 3 months of screening
- Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
- Have previously completed or withdrawn from this study or any other study investigating exenatide QW
- 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
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT01003184
Start Date
October 1 2009
End Date
December 1 2011
Last Update
April 7 2015
Active Locations (34)
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1
Research Site
Dublin, Ireland
2
Research Site
Addlestone, England, United Kingdom
3
Research Site
Bath, England, United Kingdom
4
Research Site
Birmingham, England, United Kingdom