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

This study is currently recruiting participants.
Verified March 2013 by Amylin Pharmaceuticals, LLC.
Sponsor:
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01652716
First received: July 26, 2012
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Exenatide once weekly suspension
Drug: Exenatide twice daily
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving HbA1c <7% at Week 28 [ Time Frame: Baseline (Day 1) and Week 28 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose concentrations from baseline to Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]
  • Change in body weight (kg) from baseline to Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]
  • Change in systolic blood pressure from baseline to Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]
  • Change in 2-hour postprandial glucose concentrations from baseline to Week 16 [ Time Frame: Baseline (Day 1) to Week 16 ] [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated hemoglobin) from baseline to Week 52 [ Time Frame: Baseline (Day 1) to Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving HbA1c <= 6.5% at Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652716

Contacts
Contact: Amylin Call Center 1-800-349-8919

  Show 65 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Investigators
Study Director: Vice President Medical Research & Development, M.D. Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01652716     History of Changes
Other Study ID Numbers: BCB118
Study First Received: July 26, 2012
Last Updated: March 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013