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OpenTrials
Completed

NCT Number: NCT01652729

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

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.

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exenatide once weekly suspension

Drug

Sitagliptin

Drug

Placebo

Drug

Placebo oral capsule once daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: DURATION-NEO-2

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2012
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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