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Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus (DURATION-NEO-2)

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:
NCT01652729
First received: July 26, 2012
Last updated: March 11, 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 sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Type 2
 Drug: Exenatide once weekly suspension
Drug: Sitagliptin
 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: A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

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 to Week 28 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 360
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide once weekly suspension
Exenatide once weekly suspension 2mg subcutaneous injection
 Drug: Exenatide once weekly suspension
Active Comparator: Sitagliptin 100mg
Sitagliptin 100mg oral tablet once daily
 Drug: Sitagliptin
Placebo Comparator: Placebo
Placebo oral tablet once daily

  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 of 7.1% to 11.0%, inclusive, at screening
  • Has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
  • Fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at screening
  • Body mass index of <45 kg/m2 at screening
  • Has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to Visit 1 (Screening)

Exclusion Criteria:

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • History of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 mL/min
  • Active cardiovascular disease
  • Presence or history of severe congestive heart failure
  • Central nervous system disease, including epilepsy
  • Liver disease
  • History of severe gastrointestinal diseases
  • Clinically significant malignant disease
  • Repeated severe hypoglycemia within the last 6 months
  • Any exposure to exenatide (BYETTA® or BYDUREON™) or any GLP-1 analog
  • Any DPP-4 inhibitor within 3 months prior screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652729

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

  Show 73 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: NCT01652729     History of Changes
Other Study ID Numbers: BCB120
Study First Received: July 26, 2012
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
Diabetes, Type 2, exenatide, Sitagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Sitagliptin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013