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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)

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ClinicalTrials.gov Identifier: NCT01652729
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : April 23, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Type 2 Drug: Exenatide once weekly suspension Drug: Sitagliptin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    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 :
  1. Percentage of Subjects Achieving HbA1c <7% at Week 28 [ Time Frame: Baseline to Week 28 ]
    Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.

  2. Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.

  3. Change in Body Weight (kg) From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.

  4. Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8) [ Time Frame: Baseline to Week 16 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652729


  Show 60 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Peter Ohman AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01652729     History of Changes
Other Study ID Numbers: BCB120
MB001-004 ( Other Identifier: Bristol Myers Squibb )
First Posted: July 30, 2012    Key Record Dates
Results First Posted: April 23, 2015
Last Update Posted: August 20, 2015
Last Verified: July 2015

Keywords provided by AstraZeneca:
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 Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action