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.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: July 26, 2012
Last updated: July 31, 2015
Last verified: July 2015
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
Drug: Placebo
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:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Percentage of Subjects Achieving HbA1c <7% at Week 28 [ Time Frame: Baseline to Week 28 ] [ Designated as safety issue: No ]
    Percentage 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.

Enrollment: 365
Study Start Date: February 2013
Study Completion Date: April 2014
Primary Completion Date: April 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
Overencapsulated Sitagliptin 100mg oral tablet once daily
Drug: Sitagliptin
Placebo Comparator: Placebo
Placebo oral capsule once daily
Drug: Placebo
Placebo oral capsule once daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01652729

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Sponsors and Collaborators
Study Chair: Peter Ohman AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca Identifier: NCT01652729     History of Changes
Other Study ID Numbers: BCB120, MB001-004
Study First Received: July 26, 2012
Results First Received: April 3, 2015
Last Updated: July 31, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Diabetes, Type 2, exenatide, Sitagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors processed this record on November 25, 2015