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

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide once weekly Drug: insulin detemir	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human Exenatide Insulin detemir

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26) [ Time Frame: Baseline, 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.

Secondary Outcome Measures:

Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26) [ Time Frame: Baseline, Week 26 ]
Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)
Change in HbA1c From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
Change in HbA1c from baseline to week 26
Change in Body Weight From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
Change in body weight from baseline to week 26
Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint [ Time Frame: Week 26 ]
Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint
Percentage of Patients Achieving ≤7.0% at Endpoint [ Time Frame: Week 26 ]
Percentage of patients achieving ≤7.0% at endpoint.
Percentage of Patients Achieving ≤6.5% at Endpoint [ Time Frame: Week 26 ]
Percentage of patients achieving HbA1c ≤6.5% at endpoint
Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26). [ Time Frame: Baseline, Week 26 ]
Change in fasting serum glucose from baseline to endpoint (Week 26).
Changes in Systolic Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
Change in systolic blood pressure from baseline to Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26. [ Time Frame: Baseline, Week 26 ]
Change in diastolic blood pressure from baseline to week 26.
Change in Total Cholesterol From Baseline to Endpoint (Week 26). [ Time Frame: Baseline, Week 26 ]
Change in total cholesterol from baseline to endpoint (week 26).
Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26). [ Time Frame: Baseline, Week 26 ]
Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).
Change in Triglycerides From Baseline to Endpoint (Week 26). [ Time Frame: Baseline, Week 26 ]
Change in triglycerides from baseline to endpoint (week 26).
Hypoglycemia Rate Per Year [ Time Frame: Baseline, Week 26 ]
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.


Enrollment:	222
Study Start Date:	October 2009
Study Completion Date:	December 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003184

Locations


Ireland
Research Site
Dublin, Ireland
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
Chippenham, England, United Kingdom
Research Site
Derby, England, 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
Liverpool, England, 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
Wakefield, England, United Kingdom
Research Site
Wiltshire, England, United Kingdom
Research Site
Aberdeen, Scotland, United Kingdom
Research Site
Dundee, Scotland, United Kingdom
Research Site
Carmathen, Wales, United Kingdom
Research Site
Swansea, Wales, United Kingdom
Research Site
Wrexham, Wales, United Kingdom
Research Site
Leytonstone, United Kingdom
Research Site
Livingston, United Kingdom

Sponsors and Collaborators

AstraZeneca

Eli Lilly and Company

Investigators


Study Director:	Chief Medical Officer, MD	Eli Lilly and Company

More Information


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01003184 History of Changes
Other Study ID Numbers:	H8O-EW-GWDL
Study First Received:	October 15, 2009
Results First Received:	November 20, 2012
Last Updated:	March 19, 2015

Keywords provided by AstraZeneca:


diabetes exenatide once weekly Byetta insulin detemir	Levemir Amylin Lilly

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin, Globin Zinc Exenatide	Insulin Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 29, 2017