Exenatide Acetate has been evaluated in numerous clinical trials investigating its efficacy, safety, and pharmacokinetic characteristics across diverse patient populations. These studies primarily target metabolic and endocrine conditions, including type 2 diabetes mellitus, gestational diabetes, overweight status, insulinoma, and nesidioblastosis. Spanning Early Phase 1 through Phase 3 investigations, these evaluations assess outcomes ranging from glycemic control and bioequivalence to beta-cell imaging, as exemplified in trials such as NCT06247748 and NCT02541734. Promoted by pharmaceutical sponsors like AstraZeneca and Sanofi alongside academic institutions such as Radboud University Medical Center, these clinical studies encompass completed, recruiting, active not recruiting, and terminated statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06257966 | ACTIVE_NOT_RECRUITING | Type2 Diabetes Mellitus |
Beijing Dongfang Biotech Co., Ltd. |
2024-07-17 | PHASE3 |
| NCT06254014 | ACTIVE_NOT_RECRUITING | Type 2 Diabetes Mellitus |
Beijing Dongfang Biotech Co., Ltd. |
2024-07-10 | PHASE3 |
| NCT03182296 | UNKNOWN | Gestational Diabetes |
Radboud University Medical Center |
2016-11-10 | |
| NCT04979611 | UNKNOWN | Insulinoma |
First Affiliated Hospital of Fujian Medical University |
2020-08-01 | PHASE1 |
| NCT05662189 | RECRUITING | Type1diabetes; Type2diabetes; Pre Diabetes; Hyperinsulinism |
Azienda Ospedaliero-Universitaria di Parma |
2022-03-15 | |
| NCT04615910 | UNKNOWN | Diabetes Mellitus |
Radboud University Medical Center |
2021-07-01 | PHASE2 |
| NCT03182192 | UNKNOWN | Hypoglycemia |
Radboud University Medical Center |
2016-04-01 | PHASE1 |
| NCT06247748 | COMPLETED | Diabetes Mellitus, Type 2; Overweight |
Beijing Dongfang Biotech Co., Ltd. |
2023-10-19 | PHASE1 |
| NCT03923114 | COMPLETED | Diabetes Mellitus, Type 2 |
Radboud University Medical Center |
2019-05-23 | |
| NCT05622123 | UNKNOWN | Type 1 Diabetes |
Radboud University Medical Center |
2023-02-23 | PHASE2 |
| NCT03182231 | UNKNOWN | Diabetes Mellitus, Type 2; Bariatric Surgery Candidate |
Radboud University Medical Center |
2016-10-07 | PHASE1; PHASE2 |
| NCT05034783 | UNKNOWN | Insulinoma |
Peking Union Medical College Hospital |
2021-10-01 | EARLY_PHASE1 |
| NCT04733508 | UNKNOWN | Diabetes Mellitus; Diabetes Mellitus, Type 2 |
Radboud University Medical Center |
2019-11-01 | |
| NCT03189953 | COMPLETED | Insulinoma |
Radboud University Medical Center |
2015-04 | PHASE1; PHASE2 |
| NCT04185350 | UNKNOWN | Insulinoma |
Nanjing First Hospital, Nanjing Medical University |
2019-05-05 | EARLY_PHASE1 |
| NCT03350191 | COMPLETED | Type 2 Diabetes Mellitus |
Sanofi |
2017-12-20 | PHASE1 |
| NCT02541734 | COMPLETED | Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus |
Radboud University Medical Center |
2015-08 | PHASE1; PHASE2 |
| NCT03199261 | COMPLETED | Type 2 Diabetes |
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
2016-12-23 | PHASE1 |
| NCT02560376 | UNKNOWN | Insulinoma; Nesidioblastosis |
Peking Union Medical College Hospital |
2014-02 | EARLY_PHASE1 |
| NCT01255163 | TERMINATED | Alzheimer's Disease; Mild Cognitive Impairment |
National Institute on Aging (NIA) |
2010-11-21 | PHASE2 |
| NCT01988545 | UNKNOWN | Healthy |
Zealand University Hospital |
2013-11 | |
| NCT01174810 | UNKNOWN | Parkinson's Disease |
University College, London |
2010-07 | PHASE2 |
| NCT00082407 | COMPLETED | Diabetes Mellitus, Type 2 |
AstraZeneca |
2003-11 | PHASE3 |
| NCT00082381 | COMPLETED | Diabetes Mellitus, Type 2 |
AstraZeneca |
2003-06 | PHASE3 |
| NCT00064714 | COMPLETED | Diabetes Mellitus |
AstraZeneca |
2003-07 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-09-17)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).