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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01652716
First received: July 26, 2012
Last updated: November 4, 2013
Last verified: November 2013

July 26, 2012
November 4, 2013
January 2013
September 2014   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28 [ Time Frame: Baseline (Day 1) to Week 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01652716 on ClinicalTrials.gov Archive Site
  • 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 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 ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Exenatide once weekly suspension
    Exenatide suspension 2 mg weekly subcutaneous injection
  • Drug: Exenatide twice daily
    5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
    Other Name: Byetta
  • Experimental: Exenatide once weekly suspension
    Exenatide suspension 2 mg weekly subcutaneous injection
    Intervention: Drug: Exenatide once weekly suspension
  • Active Comparator: Exenatide twice daily (BID)
    Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
    Intervention: Drug: Exenatide twice daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
375
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01652716
BCB118, MB001-003
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Vice President Medical Research & Development, M.D. Amylin Pharmaceuticals, LLC.
Bristol-Myers Squibb
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP