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

Study identifier:H8O-EW-GWDL

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Efficacy of Once-Weekly Exenatide versus Once or Twice Daily Insulin Detemir in Patients with Type 2 Diabetes Treated with Metformin Alone or in Combination with Sulphonylurea

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

Study drug

exenatide once weekly, insulin detemir

Sex

All

Actual Enrollment

222

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Oct 2009

Primary Completion Date: 01 Jul 2011

Study Completion Date: 01 Dec 2011

Study design

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

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

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

No locations available

Arms	Assigned Interventions
Experimental: 1	Drug: exenatide once weekly subcutaneous injection, 2mg, once a week
Active Comparator: 2	Drug: insulin detemir subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day Other Name: Levemir

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Chief Medical Officer