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 has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01652729
First received: July 26, 2012
Last updated: April 27, 2015
Last verified: April 2015

July 26, 2012
April 27, 2015
February 2013
April 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 ]
Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.
Change in HbA1c (glycosylated hemoglobin) from baseline to Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
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 ]
    Proportions of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.
  • Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
    The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.
  • Change in Body Weight (kg) From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
    The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.
  • Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
    The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.
  • 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
  • Drug: Placebo
    Placebo oral capsule once daily
  • Experimental: Exenatide once weekly suspension
    Exenatide once weekly suspension 2mg subcutaneous injection
    Intervention: Drug: Exenatide once weekly suspension
  • Active Comparator: Sitagliptin 100mg
    Overencapsulated Sitagliptin 100mg oral tablet once daily
    Intervention: Drug: Sitagliptin
  • Placebo Comparator: Placebo
    Placebo oral capsule once daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
April 2014
April 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
AstraZeneca
AstraZeneca
Not Provided
Study Chair: Peter Ohman AstraZeneca
AstraZeneca
April 2015

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