Primary outcome
What NCT00308139 measured first
| Exenatide Once Weeklyn=148 | Exenatide Twice Dailyn=147 |
|---|---|
| -1.87(0.082) | -1.54(0.082) |
Phase 3 · Exenatide
NCT00308139 trial results
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
Change in HbA1c From Baseline to Week 30 (percentage of total hemoglobin), Day -3, Week 30. Exenatide Once Weekly: -1.87; Exenatide Twice Daily: -1.54.
- Participants
- 303
- Status
- completed
- Completed
- 2014-08
- Sponsor
- AstraZeneca
As posted on ClinicalTrials.gov (NCT00308139), updated at source Aug 26, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT00308139
Percent of participants affected. The most common events the registry lists.
| Event | Exenatide Once Weekly (WK 0-30) | Exenatide Twice Daily (WK 0-30) | Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364) | Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364) | Exenatide Once Weekly |
|---|---|---|---|---|---|
| Any serious event | 5.4% | 3.4% | 28.1% | 22.3% | 25.5% |
| Upper respiratory tract infection | 8.1% | 17.2% | 42.2% | 49.2% | 44.6% |
| Nausea | 27% | 33.8% | 20.3% | 19.2% | 29.5% |
| Nasopharyngitis | 6.8% | 5.5% | 26.6% | 31.5% | 28.1% |
| Diarrhoea | 16.2% | 12.4% | 27.3% | 26.2% | 28.4% |
| Sinusitis | 4.7% | 6.9% | 20.3% | 26.9% | 23.7% |
| Urinary tract infection | 10.1% | 7.6% | 18% | 23.1% | 22.7% |
| Arthralgia | 4.7% | 4.1% | 19.5% | 21.5% | 20.9% |
| Back pain | 4.7% | 4.1% | 21.1% | 19.2% | 19.8% |
| Vomiting | 10.8% | 18.6% | 16.4% | 16.2% | 19.4% |
| Bronchitis | 2.7% | 4.1% | 14.1% | 19.2% | 16.5% |
| Injection site pruritus | 18.2% | 1.4% | 3.9% | 6.9% | 14.4% |
| Musculoskeletal pain | 1.4% | 0% | 18% | 11.5% | 14.4% |
| Hypertension | 3.4% | 2.8% | 17.2% | 16.9% | 17.6% |
| Pain in extremity | 0.7% | 1.4% | 16.4% | 16.9% | 15.8% |
| Constipation | 10.1% | 6.2% | 8.6% | 12.3% | 14.4% |
| Gastroenteritis viral | 8.1% | 5.5% | 14.1% | 8.5% | 13.3% |
| Gastrooesophageal reflux disease | 7.4% | 4.1% | 11.7% | 10% | 14% |
| Headache | 6.1% | 4.8% | 11.7% | 11.5% | 13.7% |
| Influenza | 1.4% | 2.1% | 8.6% | 13.1% | 10.8% |
| Cough | 3.4% | 1.4% | 10.9% | 10.8% | 11.9% |
| Cataract | 1.4% | 0% | 11.7% | 6.9% | 9% |
| Osteoarthritis | 0.7% | 1.4% | 11.7% | 7.7% | 9.4% |
| Fatigue | 6.1% | 3.4% | 8.6% | 9.2% | 11.2% |
| Rash | 0% | 0% | 10.9% | 6.2% | 7.9% |
| Oedema peripheral | 0.7% | 0% | 4.7% | 10.8% | 7.6% |
Secondary outcomes
What else it measured
| Exenatide Once Weekly -> Exenatide Once Weeklyn=58 | Exenatide Twice Daily -> Exenatide Once Weeklyn=64 | All Treatmentn=122 |
|---|---|---|
| -1.49(0.155) | -1.57(0.144) | -1.53(0.115) |
| Exenatide Once Weeklyn=148 | Exenatide Twice Dailyn=147 |
|---|---|
| 70.9 | 51.0 |
| Exenatide Once Weekly -> Exenatide Once Weeklyn=58 | Exenatide Twice Daily -> Exenatide Once Weeklyn=64 | All Treatmentn=122 |
|---|---|---|
| 41.4 | 50.0 | 45.9 |
| Exenatide Once Weeklyn=148 | Exenatide Twice Dailyn=147 |
|---|---|
| 3.0 | 16.3 |
| Exenatide Once Weekly -> Exenatide Once Weeklyn=58 | Exenatide Twice Daily -> Exenatide Once Weeklyn=64 | All Treatmeatn=122 |
|---|---|---|
| 22.4 | 37.5 | 30.3 |
| Exenatide Once Weeklyn=148 | Exenatide Twice Dailyn=147 |
|---|---|
| 23.0 | 16.3 |
| Exenatide Once Weeklyn=114 |
|---|
| 300.23(145.13 to 702.21) |
| Exenatide Once Weeklyn=22 | Exenatide Twice Dailyn=21 |
|---|---|
| -95.88(8.420) | -125.96(8.292) |
| Exenatide Once Weeklyn=148 | Exenatide Twice Dailyn=147 |
|---|---|
| -3.67(0.468) | -3.59(0.468) |
| Exenatide Once Weekly -> Exenatide Once Weeklyn=58 | Exenatide Twice Daily -> Exenatide Once Weeklyn=64 | All Treatmentn=122 |
|---|---|---|
| -5.25(0.468) | -2.71(0.468) | -3.87(-5.36 to -2.37) |
| Exenatide Once Weeklyn=148 | Exenatide Twice Dailyn=147 |
|---|---|
| -41.5(2.97) | -24.6(2.90) |
| Exenatide Once Weekly -> Exenatide Once Weeklyn=58 | Exenatide Twice Daily -> Exenatide Once Weeklyn=64 | All Treatmentn=122 |
|---|---|---|
| -18.3(2.97) | -27.7(2.90) | -23.6(-33.0 to -14.2) |
The trial
How NCT00308139 was run
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.
- Exenatide Once Weekly: Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide.
- 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.
Who could join the trial
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
Published papers
Papers from NCT00308139
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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