Summary
Pramlintide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Type 1 Diabetes would be drug repurposing rather than first-in-human development. This does not mean it is approved for Type 1 Diabetes. ClinicalTrials.gov lists 8 registered trials linking Pramlintide to Type 1 Diabetes: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01269047). The largest enrolment is 1297 participants (NCT00229658). Registration activity spans 2005 to 2022. The literature layer holds 7 publications for this pair: 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2004 to 2013. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Type 1 Diabetes Mellitus ranks 324 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Essentially zero for established T1DM (honeymoon phase occurs in 50-60% after diagnosis but lasts 3-12 months then ends); the disease is permanent autoimmune destruction of beta cells.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 55.0 (trials 19.0, literature 16.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other |
| Linked publications | 7 (5 clinical trial publications, 2 randomised controlled trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | agonist |
| Data sources | DGIdb |
| Linked via biomarker / target | CALCR |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01269047 | Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia 2009 | completed | Phase 4 | 37 |
| NCT00502138 | A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes 2007 | completed | Phase 4 | 12 |
| NCT04972175 | Safety and Efficacy of BC LisPram 2021 | status unknown | Phase 1 | 16 |
| NCT05199714 | A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes 2022 | completed | Not applicable | 12 |
| NCT00489645 | Effect of Hyperglycemia on Gastric Emptying Interactions With Pramlintide 2005 | completed | Not applicable | 27 |
| NCT00229658 | An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes 2005 | completed | Not applicable | 1,297 |
| NCT00790699 | Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port 2009 | terminated | Not applicable | 31 |
| NCT01434862 | Pramlintide Combined With Model Predictive Control Algorithm 2011 | terminated | Not applicable | 2 |
Published literature
- Clinical trial publication Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapyHerrmann K, Frias JP, Edelman SV et al. · Postgraduate medicine · 2013 · PMID 23748514
- Clinical trial publication Study reanalysis using a mechanism-based pharmacokinetic/pharmacodynamic model of pramlintide in subjects with type 1 diabetesFang J, Landersdorfer CB, Cirincione B et al. · The AAPS journal · 2013 · PMID 23054970
- Clinical trial publication Do the actions of glucagon-like peptide-1 on gastric emptying, appetite, and food intake involve release of amylin in humans?Asmar M, Bache M, Knop FK et al. · The Journal of clinical endocrinology and metabolism · 2010 · PMID 20194711
- Clinical trial publication Continuous subcutaneous pramlintide infusion therapy in patients with type 1 diabetes: observations from a pilot studyHuffman DM, McLean GW, Seagrove MA · Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2009 · PMID 19546056
- Clinical trial publication Reducing postprandial hyperglycemia with adjuvant premeal pramlintide and postmeal insulin in children with type 1 diabetes mellitusHassan K, Heptulla RA · Pediatric diabetes · 2009 · PMID 19140902
- Randomized controlled trial Properties of pramlintide and insulin upon mixingWeyer C, Fineman MS, Strobel S et al. · American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2005 · PMID 15821274
- Randomized controlled trial Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trialRatner RE, Dickey R, Fineman M et al. · Diabetic medicine : a journal of the British Diabetic Association · 2004 · PMID 15498087
Mechanism and notes
Recorded mechanism or class: agonist.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CALCR. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Pramlintide approved for Type 1 Diabetes?
Pramlintide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Type 1 Diabetes would be drug repurposing rather than first-in-human development. This does not mean it is approved for Type 1 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Pramlintide in clinical trials for Type 1 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Pramlintide to Type 1 Diabetes: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01269047). The largest enrolment is 1297 participants (NCT00229658). Registration activity spans 2005 to 2022.
What does the evidence show for Pramlintide in Type 1 Diabetes?
Pramlintide has 5 completed trials and 7 linked publications for Type 1 Diabetes. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CALCR. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.