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Completed

NCT Number: NCT02288273

Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Anaheim, California, United States

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About this study

A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus (T2DM) treated with stable dose of metformin > or = to 1500mg/day as monotherapy for at least 8 weeks
  • Hemoglobin A1c (HbA1c) 7% to 10% at screening
  • Body mass index (BMI) < or = to 45 kg/m2

Exclusion criteria

  • History of taking antihyperglycemic therapy other than metformin or metformin extended release (XR) during the 8 weeks prior to screening
  • History of taking a dipeptidyl peptidase-4 (DPP-4) inhibitor or pramlintide during 12 weeks prior to screening
  • History of potent, inhaled or intrapulmonary steroids 3 months prior to screening or during the study
  • History of prescription or over the counter weight loss medication during 3 months prior to screening
  • Previous exposure to exenatide or any glucagon-like peptide-1 (GLP-1) receptor agonist during 6 months prior to screening

Treatment and study plan

Bydureon

Drug

Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.

Other names: exenatide

Placebo

Drug

Placebo

Primary outcomes

  1. Change in 24-hour Mean Weighted Glucose

    Time frame: Day 27/28

    Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).

Secondary outcomes

  1. Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient

    Time frame: Day 64/65

  2. Change From Baseline (Day1) to Day 70 and Day 22 in FPG

    Time frame: Day 22/Day70

  3. Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)

    Time frame: Day 22 and Day 64

  4. Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10

    Time frame: Week 4 and Week 10

  5. Change in HbA1c From Baseline to Day 22 and Baseline to Day 70

    Time frame: Day 22 and Day 70

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized Double-blind, Parallel-group Study to Evaluate the Effect of BYDUREON Compared With Placebo on 24-hour Glucose Control in Metformin-treated Patients With Type 2 Diabetes

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2014
Registry last updated
Jan 27, 2017

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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