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

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ClinicalTrials.gov Identifier: NCT00308139
Recruitment Status : Completed
First Posted : March 29, 2006
Results First Posted : August 17, 2012
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: exenatide, long acting release Drug: exenatide Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Exenatide Once Weekly
Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide.
 Drug: exenatide, long acting release
Other Name: BYDUREON
Active Comparator: Exenatide Twice Daily

subcutaneous injection (SC), twice a day for the first 30 weeks, followed by exenatide LAR SC injection weekly for the remainder of the study.

Sub-study: Exenatide 2 mg subcutaneous injection, Administered Using the Exenatide Once Weekly Single-Dose Tray , once a week for 11 visits, switch to Exenatide 2 mg subcutaneous injection, Administered Using the Dual chamber pen device. Exenatide 2mg SC injection administered using the Dual chamber pen device.

 Drug: exenatide
Other Name: Byetta


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT00308139


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00308139    
Other Study ID Numbers: 2993LAR-105 (DURATION - 1)
MB001-010 ( Other Identifier: Bristol Myers Squibb )
First Posted: March 29, 2006    Key Record Dates
Results First Posted: August 17, 2012
Last Update Posted: August 26, 2015
Last Verified: July 2015
Keywords provided by AstraZeneca:
diabetes
exenatide
long acting release
 LAR
Amylin
Lilly
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists