Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01003184 |
Recruitment Status :
Completed
First Posted : October 28, 2009
Results First Posted : December 18, 2012
Last Update Posted : April 7, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: exenatide once weekly Drug: insulin detemir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 222 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
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 |
- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003184
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 |
Study Director: | Chief Medical Officer, MD | Eli Lilly and Company |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01003184 |
Other Study ID Numbers: |
H8O-EW-GWDL |
First Posted: | October 28, 2009 Key Record Dates |
Results First Posted: | December 18, 2012 |
Last Update Posted: | April 7, 2015 |
Last Verified: | March 2015 |
diabetes exenatide once weekly Byetta insulin detemir |
Levemir Amylin Lilly |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Insulin Detemir |
Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |