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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00308139 (opens ClinicalTrials.gov in a new tab)Other id2993LAR-105 (DURATION - 1)Other idMB001-010
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Overview

Status
Completed
Phase
Phase 3
Enrollment
303 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
2 countries

United States, Canada

Start
Apr 2006
Primary completion
Jul 2008
Completion
Aug 2014
First posted
29 Mar 2006 (estimated)
Last update posted
26 Aug 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062008201020122014
  1. Ph 3

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

    NCT00308139

    Apr 2006 to Aug 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • exenatide, long acting releaseDrug
  • exenatideDrug

Arms2

  • Experimental

    Exenatide Once Weekly

    Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide.

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in HbA1c From Baseline to Week 30

    Time frame · Day -3, Week 30

    Registry description

    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

    Registry description

    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(20)

  1. Change in HbA1c From Baseline to Week 364

    Time frame · Day -3, Week 364

    Registry description

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

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

    Time frame · Week 30

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Day -3, Week 30

Change in HbA1c From Baseline to Week 30

GroupValue (percentage of total hemoglobin)Spread
Exenatide Once Weekly-1.870.082
Exenatide Twice Daily-1.540.082
Primary outcome· Week 22

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)

GroupValue
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Day -3, Week 364

Change in HbA1c From Baseline to Week 364

GroupValue (percentage of total hemoglobin)Spread
Exenatide Once Weekly -> Exenatide Once Weekly-1.490.155
Exenatide Twice Daily -> Exenatide Once Weekly-1.570.144
All Treatment-1.530.115
Secondary outcomeNumber· Week 30

Percentage of Subjects Achieving HbA1c Target of <7%

GroupValue (percentage of subjects)
Exenatide Once Weekly70.9
Exenatide Twice Daily51.0
Secondary outcomeNumber· Week 364

Percentage of Subjects Achieving HbA1c Target of <7%

GroupValue (percentage of subjects)
Exenatide Once Weekly -> Exenatide Once Weekly41.4
Exenatide Twice Daily -> Exenatide Once Weekly50.0
All Treatment45.9
Secondary outcomeNumber· Week 30

Percentage of Subjects Achieving HbA1c Target of <=6.5%

GroupValue (percentage of subjects)
Exenatide Once Weekly3.0
Exenatide Twice Daily16.3
Secondary outcomeNumber· Week 364

Percentage of Subjects Achieving HbA1c Target of <=6.5%

GroupValue (percentage of subjects)
Exenatide Once Weekly -> Exenatide Once Weekly22.4
Exenatide Twice Daily -> Exenatide Once Weekly37.5
All Treatmeat30.3
Secondary outcomeNumber· Week 30

Percentage of Subjects Achieving HbA1c Target of <=6.0%

GroupValue (percentage of subjects)
Exenatide Once Weekly23.0
Exenatide Twice Daily16.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide Once Weekly (WK 0-30)Subcutaneous injection of 2 mg exenatide, once a week.–8 / 148124 / 148
Exenatide Twice Daily (WK 0-30)Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).–5 / 145106 / 145
Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)Subcutaneous injection of 2 mg exenatide, once a week.–36 / 128121 / 128
Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.–29 / 130122 / 130
Exenatide Once WeeklySubcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).–71 / 278265 / 278

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies10

Studies that cite this trial.

Studies with results

9 studies on this page

Indexing hint: Randomized controlled trial · 2019

7 results

Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study.

Philis-Tsimikas et al. 2019Journal of diabetes and its complicationscited by 20

PMID 30600137DOI 10.1016/j.jdiacomp.2018.11.012PUB-30600137

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Clinical trial · 2016

8 results

Efficacy and Tolerability of Exenatide Once Weekly Over 6 Years in Patients with Type 2 Diabetes: An Uncontrolled Open-Label Extension of the DURATION-1 Study.

Henry et al. 2016Diabetes technology & therapeuticscited by 39

PMID 27525540PMC5124747DOI 10.1089/dia.2016.0107PUB-27525540

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2015

13 results

Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial.

Wysham et al. 2015Mayo Clinic proceedingscited by 45

PMID 25744115DOI 10.1016/j.mayocp.2015.01.008PUB-25744115

Full text at the publisher13 results
Publisher pageSee results (13)

Indexing hint: Randomized controlled trial · 2013

16 results

Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.

Grimm et al. 2013Postgraduate medicinecited by 52

PMID 23748506DOI 10.3810/pgm.2013.05.2660PUB-23748506

Full text at the publisher16 results
Publisher pageSee results (16)

PubMed tag: none · 2012

15 results

Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.

Fineman et al. 2012Diabetes, obesity & metabolismcited by 117

PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356

Full text at the publisher15 results
Publisher pageSee results (15)

Indexing hint: Randomized controlled trial · 2012

7 results

Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers.

Chiquette et al. 2012Vascular health and risk managementcited by 42

PMID 23166441PMC3500143DOI 10.2147/vhrm.s37969PUB-23166441

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

PubMed tag: none · 2011

12 results

Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years.

Taylor et al. 2011BMC endocrine disorderscited by 48

PMID 21529363PMC3112417DOI 10.1186/1472-6823-11-9PUB-21529363

CC BY12 results
Download PDFSee results (12)

Indexing hint: Randomized controlled trial · 2010

8 results

DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks.

Buse et al. 2010Diabetes carecited by 267

PMID 20215461PMC2875434DOI 10.2337/dc09-1914PUB-20215461

Free to read · publisher termsCC BY-NC-ND8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2008

2 results

Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study.

Drucker et al. 2008Lancet (London, England)cited by 809

PMID 18782641DOI 10.1016/s0140-6736(08)61206-4PUB-18782641

Full text at the publisher2 results
Publisher pageSee results (2)

More studies

1 study on this page

PubMed tag: none · 2013

Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years.

Macconell et al. 2013Diabetes, metabolic syndrome and obesity : targets and therapycited by 42

PMID 23358123PMC3555554DOI 10.2147/dmso.s35801PUB-23358123

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 16 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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