Type 2 Diabetes MellitusPhase 3NCT00308139

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

A Phase 3 study testing exenatide, long acting release and exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: exenatide, long acting release and exenatide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 303 participants
Where: 25 sitesin 2 countries
Study dates: Apr 2006to Aug 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 10Show fewer

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

Trial locations and contacts

25 sites in 2 countries.

Country

City, postcode or hospital

25 sites in 2 countries

United States24 sites

Research Site 023
Butte, Montana, 59701
Research Site
Chicago, Illinois
Research Site 405
Cincinnati, Ohio, 45219
Research Site
Colorado Springs, Colorado
Research Site 015
Dallas, Texas, 75230
Research Site 017
Detroit, Michigan, 48202
Research Site 002
Durham, North Carolina, 27713
Research Site 182
Encino, California, 91436
Research Site 587
Greer, South Carolina, 29651
Research Site 149
Indianapolis, Indiana, 46254
Research Site 171
La Jolla, California, 92037
Research Site 099
Lexington, Kentucky, 40503
Research Site 557
Marion, Ohio, 43302
Research Site 057
Miami, Florida, 33156
Research Site 224
Minneapolis, Minnesota, 55416
Research Site 108
Olympia, Washington, 98502
Research Site 152
Philadelphia, Pennsylvania, 19146
Research Site 231
Portland, Oregon, 97239
Research Site 053
Rochester, New York, 14609
Research Site 009
San Antonio, Texas, 78229
Research Site 518
San Diego, California, 92161
Research Site 312
St Louis, Missouri, 63141
Research Site 024
Walnut Creek, California, 94598
Research Site 123
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada1 site

Research Site
Toronto, Ontario

Other trials in Canada

About this study

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

Read the 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.

Conditions: Type 2 Diabetes Mellitus
Being tested: exenatide, long acting release, exenatide
Keywords: diabetes, exenatide, long acting release, LAR, Amylin, Lilly
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exenatide, long acting releaseDrug
Also called BYDUREON
exenatideDrug
Also called Byetta

Study groups in NCT00308139
Study group	Role	What they receive
Exenatide Once Weekly	Experimental	Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide. Receives: Drug: exenatide, long acting release
Exenatide Twice Daily	Active comparator	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. Receives: Drug: exenatide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in HbA1c From Baseline to Week 30
Absolute change in HbA1c from Baseline (Day -3) to Week 30 [Week 30 - Baseline]
Measured: Day -3, Week 30
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)
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
Measured: Week 22

Secondary outcomes (24)

Change in HbA1c From Baseline to Week 364
Absolute change in HbA1c from Baseline (Day -3) to Week 364
Measured: Day -3, Week 364
Percentage of Subjects Achieving HbA1c Target of <7%
Percentage of subjects achieving HbA1c target value of <7% at Week 30.
Measured: Week 30
Percentage of Subjects Achieving HbA1c Target of <7%
Percentages of subjects achieving HbA1c target value of <7% at Week 364
Measured: Week 364
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 30.
Measured: Week 30
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Percentages of subjects achieving HbA1c target values of <=6.5% at Week 364
Measured: Week 364
Percentage of Subjects Achieving HbA1c Target of <=6.0%
Percentage of subjects achieving HbA1c target values of <=6.0% at Week 30.
Measured: Week 30
Exenatide LAR Steady State Concentration From 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.
Measured: Week 29 to Week 30
Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14
Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14
Measured: Day -3, Week 14
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)
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.
Measured: Week 22
Change in Body Weight From Baseline to Week 30
Change in body weight from baseline (Day -3) to Week 30
Measured: Day -3, Week 30
Change in Body Weight From Baseline to Week 364
Change in body weight from baseline (Day -3) to Week 364
Measured: Day -3, Week 364
Change in Fasting Plasma Glucose From Baseline to Week 30
Change in fasting plasma glucose from baseline (Day -3) to Week 30.
Measured: Day -3, Week 30
Change in Fasting Plasma Glucose From Baseline to Week 364
Change in fasting plasma glucose from baseline (Day -3) to Week 364.
Measured: Day -3, Week 364
Change in Blood Pressure From Baseline to Week 30
Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30
Measured: Day -3, Week 30
Change in Blood Pressure From Baseline to Week 364
Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364
Measured: Day -3, Week 364
Change in Total Cholesterol From Baseline to Week 30
Change in total cholesterol from baseline (Day -3) to Week 30.
Measured: Day -3, Week 30
Change in Total Cholesterol From Baseline to Week 364
Change in total cholesterol from baseline (Day -3) to Week 364.
Measured: Day -3, Week 364
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30
Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.
Measured: Day -3, Week 30
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364
Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.
Measured: Day -3, Week 364
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364
Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.
Measured: Day -3, Week 364
Ratio of Triglycerides at Week 30 to Baseline
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.
Measured: Day -3, Week 30
Ratio of Triglycerides at Week 364 to Baseline
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.
Measured: Day -3, Week 364
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening
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.
Measured: Day 1 to Week 364
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening
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.
Measured: Day 1 to Week 364

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Aug 2014

First posted29 Mar 2006 (estimated)
Study startApr 2006
Primary completionJul 2008
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 303 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00308139
Sponsor's protocol ID: 2993LAR-105 (DURATION - 1)
Other IDs: MB001-010
Status last verified: Jul 2015
First submitted: 27 Mar 2006
Last updated: 26 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Philis-Tsimikas A, Wysham CH, Hardy E, Han J, Iqbal N. 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. J Diabetes Complications. 2019 Mar;33(3):223-230. doi: 10.1016/j.jdiacomp.2018.11.012. Epub 2018 Dec 5.
PubMed 30600137
Henry RR, Klein EJ, Han J, Iqbal N. 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. Diabetes Technol Ther. 2016 Nov;18(11):677-686. doi: 10.1089/dia.2016.0107. Epub 2016 Aug 15.
PubMed 27525540
Wysham CH, MacConell LA, Maggs DG, Zhou M, Griffin PS, Trautmann ME. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015 Mar;90(3):356-65. doi: 10.1016/j.mayocp.2015.01.008.
PubMed 25744115
Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
PubMed 23748506
Macconell L, Pencek R, Li Y, Maggs D, Porter L. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31-41. doi: 10.2147/DMSO.S35801. Epub 2013 Jan 21.
PubMed 23358123
Chiquette E, Toth PP, Ramirez G, Cobble M, Chilton R. Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers. Vasc Health Risk Manag. 2012;8:621-9. doi: 10.2147/VHRM.S37969. Epub 2012 Nov 12.
PubMed 23166441
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
PubMed 22236356
Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocr Disord. 2011 Apr 29;11:9. doi: 10.1186/1472-6823-11-9.
PubMed 21529363
Buse JB, Drucker DJ, Taylor KL, Kim T, Walsh B, Hu H, Wilhelm K, Trautmann M, Shen LZ, Porter LE; DURATION-1 Study Group. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010 Jun;33(6):1255-61. doi: 10.2337/dc09-1914. Epub 2010 Mar 9.
PubMed 20215461
Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008 Oct 4;372(9645):1240-50. doi: 10.1016/S0140-6736(08)61206-4. Epub 2008 Sep 7.
PubMed 18782641

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00308139
Acronym / sponsor ID: 2993LAR-105 (DURATION - 1)
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes, exenatide, long acting release, LAR, Amylin, Lilly
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 303 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Jul 2008 (actual)
Study completion: Aug 2014 (actual)
First posted: 29 Mar 2006 (estimated)
Results: Posted 17 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Exenatide Once Weekly	Experimental	Drug: exenatide, long acting releaseSubcutaneous injection (SC), once a week of long acting release (LAR) exenatide.
Exenatide Twice Daily	Active comparator	Drug: exenatidesubcutaneous 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.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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:
(For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
exenatide, long acting releaseAlso: BYDUREON	Drug	Exenatide Once Weekly
exenatideAlso: Byetta	Drug	Exenatide Twice Daily

Primary outcome

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]
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

24 secondary outcomes

Change in HbA1c From Baseline to Week 364
Time frame: Day -3, Week 364
Percentage of Subjects Achieving HbA1c Target of <7%
Time frame: Week 30
Percentage of Subjects Achieving HbA1c Target of <7%
Time frame: Week 364
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Time frame: Week 30
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Time frame: Week 364
Percentage of Subjects Achieving HbA1c Target of <=6.0%
Time frame: Week 30
Exenatide LAR Steady State Concentration From Week 29 to Week 30
Time frame: Week 29 to Week 30
Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14
Time frame: Day -3, Week 14
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
Change in Body Weight From Baseline to Week 30
Time frame: Day -3, Week 30
Change in Body Weight From Baseline to Week 364
Time frame: Day -3, Week 364
Change in Fasting Plasma Glucose From Baseline to Week 30
Time frame: Day -3, Week 30
Change in Fasting Plasma Glucose From Baseline to Week 364
Time frame: Day -3, Week 364
Change in Blood Pressure From Baseline to Week 30
Time frame: Day -3, Week 30
Change in Blood Pressure From Baseline to Week 364
Time frame: Day -3, Week 364
Change in Total Cholesterol From Baseline to Week 30
Time frame: Day -3, Week 30
Change in Total Cholesterol From Baseline to Week 364
Time frame: Day -3, Week 364
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 to Week 364
Time frame: Day -3, Week 364
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364
Time frame: Day -3, Week 364
Ratio of Triglycerides at Week 30 to Baseline
Time frame: Day -3, Week 30
Ratio of Triglycerides at Week 364 to Baseline
Time frame: Day -3, Week 364
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening
Time frame: Day 1 to Week 364
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening
Time frame: Day 1 to Week 364

Results and safety

Results posted to the registry on 17 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide Once Weekly -> Exenatide Once Weekly	152	58
Exenatide Twice Daily -> Exenatide Once Weekly	151	64

Primary outcome: Change in HbA1c From Baseline to Week 30

Time frame: Day -3, Week 30. Least squares mean (Standard Error). Unit: percentage of total hemoglobin

Measure	Exenatide Once Weekly n = 148	Exenatide Twice Daily n = 147
Value	-1.87 (0.082)	-1.54 (0.082)

Exenatide Once Weekly vs Exenatide Twice Daily: Least Squares Mean Difference: -0.33 (95% CI -0.54 to -0.12), p = 0.0023, ANOVA

Population analysed: The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 30 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.

Primary outcome: 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

The sponsor has not posted figures for this outcome.

24 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide Once Weekly (WK 0-30)	8 of 148 (5.4%)	124 of 148 (83.8%)	Not reported
Exenatide Twice Daily (WK 0-30)	5 of 145 (3.4%)	106 of 145 (73.1%)	Not reported
Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)	36 of 128 (28.1%)	121 of 128 (94.5%)	Not reported
Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)	29 of 130 (22.3%)	122 of 130 (93.8%)	Not reported
Exenatide Once Weekly	71 of 278 (25.5%)	265 of 278 (95.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30600137Philis-Tsimikas A, Wysham CH, Hardy E, Han J, Iqbal N. 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. J Diabetes Complications. 2019 Mar;33(3):223-230. doi: 10.1016/j.jdiacomp.2018.11.012. Epub 2018 Dec 5.
Derived from this study: PubMed 27525540Henry RR, Klein EJ, Han J, Iqbal N. 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. Diabetes Technol Ther. 2016 Nov;18(11):677-686. doi: 10.1089/dia.2016.0107. Epub 2016 Aug 15.
Derived from this study: PubMed 25744115Wysham CH, MacConell LA, Maggs DG, Zhou M, Griffin PS, Trautmann ME. Five-year efficacy and safety data of exenatide once weekly: long-term results from the DURATION-1 randomized clinical trial. Mayo Clin Proc. 2015 Mar;90(3):356-65. doi: 10.1016/j.mayocp.2015.01.008.
Derived from this study: PubMed 23748506Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.
Derived from this study: PubMed 23358123Macconell L, Pencek R, Li Y, Maggs D, Porter L. Exenatide once weekly: sustained improvement in glycemic control and cardiometabolic measures through 3 years. Diabetes Metab Syndr Obes. 2013;6:31-41. doi: 10.2147/DMSO.S35801. Epub 2013 Jan 21.
Derived from this study: PubMed 23166441Chiquette E, Toth PP, Ramirez G, Cobble M, Chilton R. Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers. Vasc Health Risk Manag. 2012;8:621-9. doi: 10.2147/VHRM.S37969. Epub 2012 Nov 12.
Derived from this study: PubMed 22236356Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Derived from this study: PubMed 21529363Taylor K, Gurney K, Han J, Pencek R, Walsh B, Trautmann M. Exenatide once weekly treatment maintained improvements in glycemic control and weight loss over 2 years. BMC Endocr Disord. 2011 Apr 29;11:9. doi: 10.1186/1472-6823-11-9.
Derived from this study: PubMed 20215461Buse JB, Drucker DJ, Taylor KL, Kim T, Walsh B, Hu H, Wilhelm K, Trautmann M, Shen LZ, Porter LE; DURATION-1 Study Group. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care. 2010 Jun;33(6):1255-61. doi: 10.2337/dc09-1914. Epub 2010 Mar 9.
Derived from this study: PubMed 18782641Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008 Oct 4;372(9645):1240-50. doi: 10.1016/S0140-6736(08)61206-4. Epub 2008 Sep 7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa Porter, MD study director

Amylin Pharmaceuticals, LLC.

25 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exenatide, long acting release and exenatide in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline to Week 30 (time frame: Day -3, Week 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00308139, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.