Summary
Melatonin has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. ClinicalTrials.gov lists 7 registered trials linking Melatonin to Type 2 Diabetes: 1 is currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05870358). The largest enrolment is 60 participants (NCT07036796). Registration activity spans 1995 to 2025. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2021 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Type 2 Diabetes Mellitus ranks 767 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: 1.6-1.7% at 7 years on standard care (population-level cohorts UK and US).
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 56.5 (trials 21.5, literature 30.0, tier 5, approved bonus 0.0) |
| Registered trials | 7 total: 1 recruiting, 0 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review) |
| Agent type | Supplement |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023 |
| Data sources | OSMF Chronic Disease Review |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT05870358 | Melatonin Supports Non Surgical Periodontal Treatment in Patients With Type 2 Diabetes and Periodontitis 2021 | completed | Phase 4 | 55 |
| NCT02108353 | Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers 2015 | completed | Phase 3 | 46 |
| NCT00869128 | A Study of the Efficacy of Prolonged-Release Melatonin Versus Placebo in Diabetic Patients Suffering From Insomnia 1995 | completed | Phase 2 | 36 |
| NCT07036796 | Effect of Melatonin in Patients With Diabetic Peripheral Neuropathy 2025 | recruiting | Phase 2 | 60 |
| NCT03859934 | Metabolic Effects of Melatonin Treatment 2019 | completed | Phase 1 | 17 |
| NCT02691897 | Melatonin's Effects on Treatment Of Diabetes Mellitus 2019 | status unknown | Early Phase 1 | 60 |
| NCT06292000 | Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults With Prediabetes 2024 | withdrawn | Not applicable | — |
Published literature
- Clinical trial publication Natural daylight during office hours improves glucose control and whole-body substrate metabolismHarmsen JF, Habets I, Biancolin AD et al. · Cell metabolism · 2026 · PMID 41418772
- Cochrane review The Impact of Antioxidant Adjuncts on Periodontal Health in Type 2 Diabetes Patients: A Meta-AnalysisAbdulla SA, Abdalla BA, Muhammed AA et al. · Clinical and experimental dental research · 2025 · PMID 41158097
- Cochrane review The effect of melatonin supplementation on glycemic control in patients with type 2 diabetesLv X, Sun H, Ai S et al. · Frontiers in endocrinology · 2025 · PMID 40698248
- Cochrane review The role of melatonin and circadian rhythms in the pathogenesis of diabetic retinopathy: A systematic reviewSenthil MP, Devlin E, Hassani A et al. · Diabetes & metabolic syndrome · 2025 · PMID 39933215
- Meta-analysis Impact of Melatonin Supplementation on Glycemic Parameters in Patients with Type 2 Diabetes: A Systematic Review and Meta-analysisAbadi RNS, Jazinaki MS, Bahari H et al. · Current pharmaceutical design · 2025 · PMID 39428939
- Clinical trial publication Effects of light therapy on sleep and circadian rhythm in older type 2 diabetics living in long-term care facilities: a randomized controlled trialWang Q, Wu S, Luo Z et al. · Frontiers in endocrinology · 2024 · PMID 38375195
- Clinical trial publication Melatonin supports nonsurgical periodontal treatment in patients with Type 2 diabetes mellitus and periodontitis: A randomized clinical trialSarac Gul Y, Kose O, Altin A et al. · Journal of periodontology · 2024 · PMID 38055628
- Clinical trial publication MTNR1B genotype and effects of carbohydrate quantity and dietary glycaemic index on glycaemic response to an oral glucose load: the OmniCarb trialHeianza Y, Zhou T, Wang X et al. · Diabetologia · 2024 · PMID 38052941
- Clinical trial publication Effect of oral melatonin treatment on insulin resistance and diurnal blood pressure variability in night shift workers. A double-blind, randomized, placebo-controlled studyHannemann J, Laing A, Middleton B et al. · Pharmacological research · 2024 · PMID 38029806
- Systematic review A systematic review of variations in circadian rhythm genes and type 2 diabetesStevens H, Verdone G, Lang L et al. · Nutrition and health · 2024 · PMID 37282546
- Cochrane review Effects of Melatonin Supplementation on Insulin Levels and Insulin Resistance: A Systematic Review and Meta-Analysis of Randomized Controlled TrialsLi Y, Xu Z · Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2021 · PMID 34496412
- Cochrane review Interventions for preventing type 2 diabetes in adults with mental disorders in low- and middle-income countriesMishu MP, Uphoff E, Aslam F et al. · The Cochrane database of systematic reviews · 2021 · PMID 33591592
- Meta-analysis Effects of daily administration of melatonin before bedtime on fasting insulin, glucose and insulin sensitivity in healthy adults and patients with metabolic diseases. A systematic review and meta-analysisLauritzen ES, Kampmann U, Smedegaard SB et al. · Clinical endocrinology · 2021 · PMID 34370338
Mechanism and notes
Recorded mechanism or class: Potential dietary and lifestyle interventions for decreasing insulin resistance · Halma MTJ, Syed M, Marik PE · 2023.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Melatonin approved for Type 2 Diabetes?
Melatonin has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Type 2 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Melatonin in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 7 registered trials linking Melatonin to Type 2 Diabetes: 1 is currently recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT05870358). The largest enrolment is 60 participants (NCT07036796). Registration activity spans 1995 to 2025.
What does the evidence show for Melatonin in Type 2 Diabetes?
Melatonin has both completed registered trials and synthesis-level publications linked to Type 2 Diabetes. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. 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.