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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003184
• Other study ID #: H8O-EW-GWDL
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2009
• Last updated: March 19, 2015
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide once weekly
subcutaneous injection, 2mg, once a week
• insulin detemir
subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day

Locations

Country	Name	City	State
Ireland	Research Site	Dublin
United Kingdom	Research Site	Aberdeen	Scotland
United Kingdom	Research Site	Addlestone	England
United Kingdom	Research Site	Bath	England
United Kingdom	Research Site	Birmingham	England
United Kingdom	Research Site	Blackburn	England
United Kingdom	Research Site	Bournemouth	England
United Kingdom	Research Site	Carmathen	Wales
United Kingdom	Research Site	Chippenham	England
United Kingdom	Research Site	Derby	England
United Kingdom	Research Site	Dundee	Scotland
United Kingdom	Research Site	Exeter	England
United Kingdom	Research Site	High Wycombe	England
United Kingdom	Research Site	Hull	England
United Kingdom	Research Site	Leicester	England
United Kingdom	Research Site	Leytonstone
United Kingdom	Research Site	Liverpool	England
United Kingdom	Research Site	Livingston
United Kingdom	Research Site	London	England
United Kingdom	Research Site	Manchester	England
United Kingdom	Research Site	Merseyside	England
United Kingdom	Research Site	Middlesborough	England
United Kingdom	Research Site	Newcastle	England
United Kingdom	Research Site	Northampton	England
United Kingdom	Research Site	Oldham	England
United Kingdom	Research Site	Plymouth	England
United Kingdom	Research Site	Portsmouth	England
United Kingdom	Research Site	Sheffield	England
United Kingdom	Research Site	Stevenage	England
United Kingdom	Research Site	Suffolk	England
United Kingdom	Research Site	Swansea	Wales
United Kingdom	Research Site	Wakefield	England
United Kingdom	Research Site	Wiltshire	England
United Kingdom	Research Site	Wrexham	Wales

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration =7.0% With Weight Loss (=1.0 kg) at Endpoint (Week 26)	The primary endpoint is the percentage of patients achieving HbA1c concentration =7.0% with weight loss (=1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.	Baseline, Week 26	No
Secondary	Percentage of Patients Who Have Achieved HbA1c =7.4% With Weight Loss (=1.0 kg) at Endpoint (Week 26)	Percentage of patients who have achieved HbA1c =7.4% with weight loss (=1.0 kg) at endpoint (Week 26)	Baseline, Week 26	No
Secondary	Change in HbA1c From Baseline to Week 26	Change in HbA1c from baseline to week 26	Baseline, Week 26	No
Secondary	Change in Body Weight From Baseline to Week 26	Change in body weight from baseline to week 26	Baseline, Week 26	No
Secondary	Percentage of Patients Achieving HbA1c =7.4% at Endpoint	Percentage of patients who have achieved HbA1c =.7.4% at endpoint	Week 26	No
Secondary	Percentage of Patients Achieving =7.0% at Endpoint	Percentage of patients achieving =7.0% at endpoint.	Week 26	No
Secondary	Percentage of Patients Achieving =6.5% at Endpoint	Percentage of patients achieving HbA1c =6.5% at endpoint	Week 26	No
Secondary	Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).	Change in fasting serum glucose from baseline to endpoint (Week 26).	Baseline, Week 26	No
Secondary	Changes in Systolic Blood Pressure From Baseline to Week 26	Change in systolic blood pressure from baseline to Week 26	Baseline, Week 26	No
Secondary	Change in Diastolic Blood Pressure From Baseline to Week 26.	Change in diastolic blood pressure from baseline to week 26.	Baseline, Week 26	No
Secondary	Change in Total Cholesterol From Baseline to Endpoint (Week 26).	Change in total cholesterol from baseline to endpoint (week 26).	Baseline, Week 26	No
Secondary	Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).	Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).	Baseline, Week 26	No
Secondary	Change in Triglycerides From Baseline to Endpoint (Week 26).	Change in triglycerides from baseline to endpoint (week 26).	Baseline, Week 26	No
Secondary	Hypoglycemia Rate Per Year	All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.	Baseline, Week 26	Yes