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OpenTrials
Completed

NCT Number: NCT01652716

Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus 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, Muscle Shoals, 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 7.1 to 11%, inclusive, at screening
  • Fasting plasma glucose <280 mg/dL (15.5 mmol/L)
  • Body mass index (BMI) <=45 kg/m2, inclusive, at screening
  • Treated with diet and exercise or a stable regimen of metformin, sulfonylurea, pioglitazone or any 2 of these agents

Exclusion criteria

  • History of pancreatitis or triglycerides >=500 mg/dL
  • Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of either
  • Active cardiovascular disease
  • Presence of congestive heart failure
  • Liver disease
  • History of severe gastrointestinal diseases
  • Repeated severe hypoglycemia within the last 6 months
  • Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog
  • Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months

Treatment and study plan

Exenatide once weekly suspension

Drug

Exenatide suspension 2 mg weekly subcutaneous injection

exenatide twice daily

Drug

5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks

Other names: Byetta

Primary outcomes

  1. Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28

    Time frame: Baseline to Week 28

    The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

Secondary outcomes

  1. Percentage of Subjects Achieving HbA1c <7% at Week 28

    Time frame: Baseline to Week 28

    Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination

  2. Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28

    Time frame: Baseline to Week 28

    Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination

  3. Change in Body Weight (kg) From Baseline to Week 28

    Time frame: Baseline to Week 28

    Change in body weight (kg) from baseline to Week 28/Study Termination.

  4. Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16

    Time frame: Baseline to Week 16

    Change in 2-hour postprandial glucose concentrations from baseline to Week 16.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

Acronym: DURATION-NEO-1

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2012
Registry last updated
Jul 3, 2018

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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