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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01652729
First received: July 26, 2012
Last updated: April 3, 2014
Last verified: April 2014

July 26, 2012
April 3, 2014
February 2013
June 2014   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01652729 on ClinicalTrials.gov Archive Site
  • 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 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 ]
  • 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 ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Type 2
  • Drug: Exenatide once weekly suspension
  • Drug: Sitagliptin
  • Experimental: Exenatide once weekly suspension
    Exenatide once weekly suspension 2mg subcutaneous injection
    Intervention: Drug: Exenatide once weekly suspension
  • Active Comparator: Sitagliptin 100mg
    Sitagliptin 100mg oral tablet once daily
    Intervention: Drug: Sitagliptin
  • Placebo Comparator: Placebo
    Placebo oral tablet once 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
360
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01652729
BCB120, MB001-004
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Vice President Medical Research & Development, M.D. Amylin Pharmaceuticals, LLC.
Bristol-Myers Squibb
April 2014

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