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Completed

NCT Number: NCT00308139

Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Toronto, Ontario, Canada

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About this study

This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. The study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly. Long-term safety and efficacy will be monitored during the open-ended assessment periods. This study will be conducted in approximately 300 subjects with type 2 diabetes treated with diet modification and exercise alone or in combination with a stable regimen of metformin, SU, thiazolidinedione (TZD), a combination of metformin and SU, a combination of metformin and TZD, or a combination of SU and TZD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
  • Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
  • Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
  • (For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105

Exclusion criteria

  • Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.
  • Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
  • Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
  • Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
  • Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
  • Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
  • Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
  • Regular use (> 14 days) of medications with addictive potential such as opiates and opioids;
  • Prescription or over-the-counter weight loss medications within 6 months of screening.
  • (For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy

Treatment and study plan

exenatide, long acting release

Drug

Other names: BYDUREON

exenatide

Drug

Other names: Byetta

Primary outcomes

  1. Change in HbA1c From Baseline to Week 30

    Time frame: Day -3, Week 30

    Absolute change in HbA1c from Baseline (Day -3) to Week 30 [Week 30 - Baseline]

  2. Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)

    Time frame: Week 22

    Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval

Secondary outcomes

  1. Change in HbA1c From Baseline to Week 364

    Time frame: Day -3, Week 364

    Absolute change in HbA1c from Baseline (Day -3) to Week 364

  2. Percentage of Subjects Achieving HbA1c Target of <7%

    Time frame: Week 30

    Percentage of subjects achieving HbA1c target value of <7% at Week 30.

  3. Percentage of Subjects Achieving HbA1c Target of <7%

    Time frame: Week 364

    Percentages of subjects achieving HbA1c target value of <7% at Week 364

  4. Percentage of Subjects Achieving HbA1c Target of <=6.5%

    Time frame: Week 30

    Percentages of subjects achieving HbA1c target values of <=6.5% at Week 30.

  5. Percentage of Subjects Achieving HbA1c Target of <=6.5%

    Time frame: Week 364

    Percentages of subjects achieving HbA1c target values of <=6.5% at Week 364

  6. Percentage of Subjects Achieving HbA1c Target of <=6.0%

    Time frame: Week 30

    Percentage of subjects achieving HbA1c target values of <=6.0% at Week 30.

  7. Exenatide LAR Steady State Concentration From Week 29 to Week 30

    Time frame: Week 29 to Week 30

    Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.

  8. Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14

    Time frame: Day -3, Week 14

    Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14

  9. Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)

    Time frame: Week 22

    Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.

  10. Change in Body Weight From Baseline to Week 30

    Time frame: Day -3, Week 30

    Change in body weight from baseline (Day -3) to Week 30

  11. Change in Body Weight From Baseline to Week 364

    Time frame: Day -3, Week 364

    Change in body weight from baseline (Day -3) to Week 364

  12. Change in Fasting Plasma Glucose From Baseline to Week 30

    Time frame: Day -3, Week 30

    Change in fasting plasma glucose from baseline (Day -3) to Week 30.

  13. Change in Fasting Plasma Glucose From Baseline to Week 364

    Time frame: Day -3, Week 364

    Change in fasting plasma glucose from baseline (Day -3) to Week 364.

  14. Change in Blood Pressure From Baseline to Week 30

    Time frame: Day -3, Week 30

    Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30

  15. Change in Blood Pressure From Baseline to Week 364

    Time frame: Day -3, Week 364

    Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364

  16. Change in Total Cholesterol From Baseline to Week 30

    Time frame: Day -3, Week 30

    Change in total cholesterol from baseline (Day -3) to Week 30.

  17. Change in Total Cholesterol From Baseline to Week 364

    Time frame: Day -3, Week 364

    Change in total cholesterol from baseline (Day -3) to Week 364.

  18. Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30

    Time frame: Day -3, Week 30

    Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.

  19. Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364

    Time frame: Day -3, Week 364

    Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.

  20. Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364

    Time frame: Day -3, Week 364

    Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.

  21. Ratio of Triglycerides at Week 30 to Baseline

    Time frame: Day -3, Week 30

    Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

  22. Ratio of Triglycerides at Week 364 to Baseline

    Time frame: Day -3, Week 364

    Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

  23. Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening

    Time frame: Day 1 to Week 364

    The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.

  24. Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening

    Time frame: Day 1 to Week 364

    The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications

Important dates

Study start
2006
Primary completion
2008
Study completion
2014
First posted
Mar 29, 2006
Registry last updated
Aug 26, 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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