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

This study has been completed.
Sponsor:
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
  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
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

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

ClinicalTrials.gov processed this record on August 21, 2014