Primary outcomeLeast squares mean· Day 1, Week 24
Change in HbA1c From Baseline to Week 24
| Group | Value (percentage of total hemoglobin) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.57 | 0.104 |
| Exenatide Twice Daily | -0.90 | 0.110 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)
NCTNCT00877890 (opens ClinicalTrials.gov in a new tab)Other idBCB108 (DURATION-5)
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 254 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Mar 2009
- Primary completion
- Oct 2009
- Completion
- Jan 2010
- First posted
- 8 Apr 2009 (estimated)
- Last update posted
- 7 Apr 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
200920102011
- Ph 3
A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)
NCT00877890Mar 2009 to Jan 2010
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.
Interventions
- exenatide once weeklyDrug
- exenatide twice dailyDrug
Arms2
Experimental
1
Active comparator
2
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline to Week 24
Time frame · Day 1, Week 24
Registry description
Change in HbA1c from baseline (Day 1) to Week 24 \[Week 24 - Baseline\].
Secondary outcomes(12)
Percentage of Subjects Achieving HbA1c Target of <7%
Time frame · Week 24
Registry description
Percentages of subjects achieving HbA1c target value of \<7% at Week 24.
Percentage of Subjects Achieving HbA1c Target of <=6.5%
Time frame · Week 24
Registry description
Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24.
Change in Fasting Plasma Glucose From Baseline to Week 24
Time frame · Day 1, Week 24
Registry description
Change in fasting plasma glucose from baseline (Day 1) to Week 24.
Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL
Time frame · Week 24
Registry description
Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24.
Change in Body Weight From Baseline to Week 24
Time frame · Day 1, Week 24
Registry description
Change in body weight from baseline (Day 1) to Week 24.
Change in Sitting Systolic Blood Pressure From Baseline to Week 24
Time frame · Day 1, Week 24
Registry description
Change in systolic blood pressure from baseline (Day 1) to Week 24.
Change in Sitting Diastolic Blood Pressure From Baseline to Week 24
Time frame · Day 1, Week 24
Registry description
Change in diastolic blood pressure from baseline (Day 1) to Week 24.
Change in Total Cholesterol From Baseline to Week 24
Time frame · Day 1, Week 24
Registry description
Change in total cholesterol from baseline (Day 1) to Week 24.
Change in High-density Lipoprotein (HDL) From Baseline to Week 24
Time frame · Day 1, Week 24
Registry description
Change in HDL from baseline (Day 1) to Week 24.
Ratio of Triglycerides at Week 24 to Baseline
Time frame · Day 1, Week 24
Registry description
Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Time frame · Day 1 to Week 24
Registry description
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.
Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
Time frame · Day 1 to Week 24
Registry description
The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 24
Percentage of Subjects Achieving HbA1c Target of <7%
| Group | Value (percentage of subjects) |
|---|---|
| Exenatide Once Weekly | 58.1 |
| Exenatide Twice Daily | 30.1 |
Secondary outcomeNumber· Week 24
Percentage of Subjects Achieving HbA1c Target of <=6.5%
| Group | Value (percentage of subjects) |
|---|---|
| Exenatide Once Weekly | 41.1 |
| Exenatide Twice Daily | 16.3 |
Secondary outcomeLeast squares mean· Day 1, Week 24
Change in Fasting Plasma Glucose From Baseline to Week 24
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide Once Weekly | -25.1 | 4.32 |
| Exenatide Twice Daily | -4.6 | 4.50 |
Secondary outcomeNumber· Week 24
Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL
| Group | Value (percentage of subjects) |
|---|---|
| Exenatide Once Weekly | 50.4 |
| Exenatide Twice Daily | 30.9 |
Secondary outcomeLeast squares mean· Day 1, Week 24
Change in Body Weight From Baseline to Week 24
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.33 | 0.369 |
| Exenatide Twice Daily | -1.37 | 0.386 |
Secondary outcomeLeast squares mean· Day 1, Week 24
Change in Sitting Systolic Blood Pressure From Baseline to Week 24
| Group | Value (mmHg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.9 | 1.13 |
| Exenatide Twice Daily | -1.2 | 1.19 |
Secondary outcomeLeast squares mean· Day 1, Week 24
Change in Sitting Diastolic Blood Pressure From Baseline to Week 24
| Group | Value (mmHg) | Spread |
|---|---|---|
| Exenatide Once Weekly | 0.2 | 0.74 |
| Exenatide Twice Daily | -0.1 | 0.78 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide Once WeeklySubcutaneous injection of 2 mg exenatide, once a week | – | 3 / 129 | 44 / 129 |
| Exenatide Twice DailySubcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) | – | 5 / 123 | 58 / 123 |
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
Studies4
Studies that cite this trial.
Studies with results
3 studies on this page
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
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
Indexing hint: Randomized controlled trial · 2011
7 results
DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes.
Blevins et al. 2011The Journal of clinical endocrinology and metabolismcited by 340
PMID 21307137DOI 10.1210/jc.2010-2081PUB-21307137
Full text at the publisher7 results
More studies
1 study on this page
PubMed tag: none · 2016
Onset of Glycemic and Weight Outcomes in Patients Initiating Exenatide Once Weekly: The Relationship of Exenatide Exposure with Efficacy over the First 24 Weeks of Treatment.
Blevins et al. 2016Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 3
PMID 27146799PMC4900982DOI 10.1007/s13300-016-0172-0PUB-27146799
Free to read · publisher termsCC BY-NC
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedPeyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125. PMID 23039868
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Has been diagnosed with type 2 diabetes mellitus
* Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
* Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
* Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening
* Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to screening:
* Hormone replacement therapy (female subjects)
* Oral contraceptives (female subjects)
* Antihypertensive agents
* Lipid-lowering agents
* Thyroid replacement therapy
* Antidepressant agents
* Drugs known to affect body weight, including prescription medications (e.g. orlistat \[XENICAL®\], sibutramine \[MERIDIA®\], topiramate \[TOPAMAX®\]) and over the counter antiobesity agents
Exclusion Criteria:
* Has ever been exposed to exenatide (exenatide once weekly \[exenatide LAR\], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
* Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
* Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
* Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
* Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
* Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
* Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
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