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Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes (DURATION-NEO-1)

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: NCT01652716
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : September 16, 2015
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Exenatide once weekly suspension Drug: Exenatide twice daily Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus
Study Start Date : January 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
 Drug: Exenatide once weekly suspension
Exenatide suspension 2 mg weekly subcutaneous injection
Active Comparator: Exenatide twice daily (BID)
Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
 Drug: Exenatide twice daily
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Other Name: Byetta


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.


Secondary Outcome Measures :
  1. Percentage of Subjects Achieving HbA1c <7% at Week 28 [ Time Frame: Baseline to Week 28 ]
    Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination

  2. Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination

  3. Change in Body Weight (kg) From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    Change in body weight (kg) from baseline to Week 28/Study Termination.

  4. Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
    Change in 2-hour postprandial glucose concentrations from baseline to Week 16.


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

Inclusion Criteria:

  • At least 18 years old
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c 7.1 to 11%, inclusive, at screening
  • Fasting plasma glucose <280 mg/dL (15.5 mmol/L)
  • Body mass index (BMI) <=45 kg/m2, inclusive, at screening
  • Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion Criteria:

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • Active cardiovascular disease
  • Presence of congestive heart failure
  • Liver disease
  • History of severe gastrointestinal diseases
  • Repeated severe hypoglycemia within the last 6 months
  • Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
  • Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01652716


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Vice President Medical Research & Development, M.D. Amylin Pharmaceuticals, LLC.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01652716    
Other Study ID Numbers: BCB118
MB001-003 ( Other Identifier: Bristol Myers Squibb )
First Posted: July 30, 2012    Key Record Dates
Results First Posted: September 16, 2015
Last Update Posted: July 3, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists