Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01003184
First received: October 15, 2009
Last updated: June 6, 2014
Last verified: June 2014
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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 Endpoint Classification: Safety/Efficacy Study 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:
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Change in HbA1c from baseline to week 26
- Change in Body Weight From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]Change in body weight from baseline to week 26
- Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint [ Time Frame: Week 26 ] [ Designated as safety issue: No ]Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint
- Percentage of Patients Achieving ≤7.0% at Endpoint [ Time Frame: Week 26 ] [ Designated as safety issue: No ]Percentage of patients achieving ≤7.0% at endpoint.
- Percentage of Patients Achieving ≤6.5% at Endpoint [ Time Frame: Week 26 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Change in triglycerides from baseline to endpoint (week 26).
- Hypoglycemia Rate Per Year [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: Yes ]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 |
| Genders Eligible for Study: | Both |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003184
Locations
| Ireland | |
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| Dublin, Ireland | |
| United Kingdom | |
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| Addlestone, England, United Kingdom | |
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| Bath, England, United Kingdom | |
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| Birmingham, England, United Kingdom | |
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| Blackburn, England, United Kingdom | |
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| Bournemouth, England, United Kingdom | |
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| Chippenham, England, United Kingdom | |
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| Derby, England, United Kingdom | |
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| Exeter, England, United Kingdom | |
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| High Wycombe, England, United Kingdom | |
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| Hull, England, United Kingdom | |
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| Leicester, England, United Kingdom | |
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| Liverpool, England, United Kingdom | |
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| London, England, United Kingdom | |
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| Manchester, England, United Kingdom | |
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| Merseyside, England, United Kingdom | |
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| Middlesborough, England, United Kingdom | |
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| Newcastle, England, United Kingdom | |
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| Northampton, England, United Kingdom | |
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| Oldham, England, United Kingdom | |
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| Plymouth, England, United Kingdom | |
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| Portsmouth, England, United Kingdom | |
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| Sheffield, England, United Kingdom | |
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| Stevenage, England, United Kingdom | |
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| Suffolk, England, United Kingdom | |
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| Wakefield, England, United Kingdom | |
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| Wiltshire, England, United Kingdom | |
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| Aberdeen, Scotland, United Kingdom | |
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| Dundee, Scotland, United Kingdom | |
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| Carmathen, Wales, United Kingdom | |
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| Swansea, Wales, United Kingdom | |
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| Wrexham, Wales, United Kingdom | |
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| 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
No publications provided
| 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: | June 6, 2014 |
| Health Authority: | Ireland: Irish Medicines Board United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
diabetes exenatide once weekly Byetta insulin detemir |
Levemir Amylin Lilly |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Exenatide |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015