A Phase 3 interventional study of Exenatide once weekly suspension and Exenatide twice daily in Diabetes Mellitus, Type 2, sponsored by AstraZeneca. Completed at 58 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-03.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.
To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 377 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exenatide suspension 2 mg weekly subcutaneous injection
Drug: Exenatide once weekly suspension
Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
Drug: Exenatide twice daily
Exenatide suspension 2 mg weekly subcutaneous injection
5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Also known as: Byetta
Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28
The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.
Time frame: Baseline to Week 28
Percentage of Subjects Achieving HbA1c <7% at Week 28
Percentage of subjects achieving HbA1c \<7% at Week 28/Study Termination
Time frame: Baseline to Week 28
Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28
Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination
Time frame: Baseline to Week 28
Change in Body Weight (kg) From Baseline to Week 28
Change in body weight (kg) from baseline to Week 28/Study Termination.
Time frame: Baseline to Week 28
Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16
Change in 2-hour postprandial glucose concentrations from baseline to Week 16.
Time frame: Baseline to Week 16
| Milestone | Experimental: Exenatide Once Weekly (QWS) Suspension | Active Comparator: Exenatide Twice Daily (BID) |
|---|---|---|
| Started | 229 | 148 |
| Completed 28-week | 197 | 118 |
| Completed | 173 | 102 |
| Not completed | 56 | 46 |
| Withdrew: Loss of glucose control | 1 | 0 |
| Withdrew: Administrative | 0 | 2 |
| Withdrew: Investigator decision | 1 | 4 |
| Withdrew: Lost to follow-up | 12 | 11 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Adverse event | 7 | 10 |
| Withdrew: Withdrawal by subject | 33 | 18 |
The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.
| Percentage of total hemoglobin | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID |
|---|---|---|
| Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28 | -1.39 ± 0.0930 | -1.02 ± 0.1147 |
Percentage of subjects achieving HbA1c \<7% at Week 28/Study Termination
| Percentage of subjects | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID |
|---|---|---|
| Baseline Yes | 3.9 | 1.4 |
| Baseline No | 95.2 | 98.6 |
| Week 28 Yes | 49.3 | 43.2 |
| Week 28 No | 49.8 | 56.8 |
| Baseline missing | 0.9 | 0 |
Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination
| mg/dL | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID |
|---|---|---|
| Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28 | -32.7 ± 3.906 | -22.5 ± 4.917 |
Change in body weight (kg) from baseline to Week 28/Study Termination.
| kg | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID |
|---|---|---|
| Change in Body Weight (kg) From Baseline to Week 28 | -1.49 ± 0.2842 | -1.89 ± 0.3640 |
Change in 2-hour postprandial glucose concentrations from baseline to Week 16.
| mg/dL | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID |
|---|---|---|
| Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 | -87.00 ± 12.8374 | -113.74 ± 14.8042 |
Collected over up to 52 week data reported. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Exenatide QWS Suspension | — | 12/229 (5.2%) | 121/229 (52.8%) |
| Active Comparator: Exenatide BID | — | 17/146 (11.6%) | 94/146 (64.4%) |
| Event | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID |
|---|---|---|
| PancreatitisGastrointestinal disorders | 2/229 | 0/146 |
| CellulitisInfections and infestations | 0/229 | 1/146 |
| Septic ShockInfections and infestations | 0/229 | 1/146 |
| Diverticular PerforationGastrointestinal disorders | 0/229 | 1/146 |
| Toxic EncephalopathyNervous system disorders | 0/229 | 1/146 |
| Drug Withdrawal SyndromeGeneral disorders | 0/229 | 1/146 |
| Lactic AcidosisMetabolism and nutrition disorders | 0/229 | 1/146 |
| Basal Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/229 | 1/146 |
| Uterine LeiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/229 | 1/146 |
| Renal Failure AcuteRenal and urinary disorders | 0/229 | 1/146 |
| Event | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID |
|---|---|---|
| NauseaGastrointestinal disorders | 22/229 | 33/146 |
| Injection Site NoduleGeneral disorders | 36/229 | 6/146 |
| DiarrhoeaGastrointestinal disorders | 14/229 | 18/146 |
| VomitingGastrointestinal disorders | 9/229 | 11/146 |
| Upper Respiratory Tract InfectionInfections and infestations | 15/229 | 8/146 |
| HeadacheNervous system disorders | 14/229 | 9/146 |
| NasopharyngitisInfections and infestations | 11/229 | 9/146 |
Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug
| Age, Continuous(Years) | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID | Total |
|---|---|---|---|
| Mean | 55.6 ± 9.98 | 56.5 ± 9.04 | 56.0 ± 9.62 |
| Age, Customized(Participants) | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID | Total |
|---|---|---|---|
| <65 years | 182 | 118 | 300 |
| >=65 years | 47 | 28 | 75 |
| Sex: Female, Male(Participants) | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID | Total |
|---|---|---|---|
| Female | 81 | 54 | 135 |
| Male | 148 | 92 | 240 |
| Race/Ethnicity, Customized(Participants) | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID | Total |
|---|---|---|---|
| Hispanic or Latino | 54 | 34 | 88 |
| Not Hispanic or Latino | 174 | 112 | 286 |
| Unknown | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID | Total |
|---|---|---|---|
| White | 168 | 110 | 278 |
| Black or African American | 38 | 23 | 61 |
| Asian | 17 | 8 | 25 |
| Other | 3 | 2 | 5 |
| American Indian or Alaska Native | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Weight(lbs) | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID | Total |
|---|---|---|---|
| Mean | 214.52 ± 49.788 | 213.19 ± 40.834 | 214.00 ± 46.445 |
| Baseline HbA1c(Percentage of total hemoglobin) | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID | Total |
|---|---|---|---|
| Mean | 8.47 ± 1.047 | 8.51 ± 1.004 | 8.48 ± 1.029 |
| HbA1c Stratum(Number of subjects) | Experimental: Exenatide QWS Suspension | Active Comparator: Exenatide BID | Total |
|---|---|---|---|
| <9.0% | 159 | 97 | 256 |
| >=9.0% | 68 | 49 | 117 |
| Not Recorded | 2 | 0 | 2 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca