Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: exenatide once weekly

Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01003184

H8O-EW-GWDL

Details and patient eligibility

About

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 outcomes.

Enrollment

222 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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Have previously completed or withdrawn from this study or any other study investigating exenatide QW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