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Disease

Diabetes Mellitus

Late-stage therapeutic developmentExtensively researchedCooling momentum
MeSHDiabetes Mellitus
112
Publications
24
Clinical trials
12
Related conditions
6
Related treatments
12
Associated genes
12
Related proteins
2026
Latest publication
Current focus
Glucagon-like 1 biologyInsulin biologyTherapeutic developmentInflammation & immunityMetabolic & lifestyle factorsDisease mechanisms & pathology
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes

Clinical trial2026-08-31Results posted · ClinicalTrials.gov

Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes

Clinical trial2026-08-31Status changed to Terminated · ClinicalTrials.gov

Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES)

Clinical trial2026-08-04Status changed to Completed · ClinicalTrials.gov

A Phase 1, Investigator- and Participant-Blinded Study to Evaluate the Effect of Retatrutide on α- and β- Cell Function and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus

Clinical trial2026-07-16Status changed to Active, not recruiting · ClinicalTrials.gov

Biosimilar medicine authorisation: Bysumlog (EMA)

Regulatory2026-05-06EMA

Biosimilar medicine authorisation: Dazparda (EMA)

Regulatory2026-04-27EMA

Biosimilar medicine authorisation: Ondibta (EMA)

Regulatory2026-01-09EMA

Diabetes Mellitus and Infectious Diseases: Current Evidence and Clinical Implications.

Research2025-08-27Diabetes & metabolism journal

Global Effect of Cardiovascular Risk Factors on Lifetime Estimates.

Research2025-03-30The New England journal of medicine

10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes-2025.

Research2025-01-01Diabetes care

Periodontal bacteria influence systemic diseases through the gut microbiota.

Research2024-11-15Frontiers in cellular and infection microbiology

Marketing authorisation: Zegalogue (EMA)

Regulatory2024-07-24EMA

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: High
Key developments
  • 6 clinical trials expected to report results, the earliest in Q1 2027.
  • 4 industry developments reported.
Upcoming Milestones
Major developments
Upcoming trial readoutHigh impact
A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)
Results expected Q4 20272026-10-02
Upcoming trial readoutHigh impact
EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)
Results expected Q4 20272026-09-08
Regulatory developmentWorth watching
Biosimilar approval — Insulin Lispro
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Bysumlog is also indicated for the initial stabilisation of diabetes mellitus.2026-05-06
Clinical Milestones13View all 13
Results posted 1
Results expected 5
Other updates 5
+5 more in the activity timeline below
Industry & Market4View
Regulatory Updates9View all 9
  • 2026-07-29Product authorisation ended — RepaglinideRepaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
  • 2026-05-06Biosimilar approval — Insulin LisproFor the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Bysumlog is also indicated for the initial stabilisation of diabetes mellitus.
  • 2026-05-04Product authorisation ended — TelmisartanHypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.
  • 2026-04-30Product authorisation ended — TelmisartanHypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.
  • 2026-04-27Biosimilar approval — Insulin AspartDazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
  • 2026-01-09Biosimilar approval — Insulin GlargineTreatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
+3 more in the activity timeline below
Activity timeline26

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Exenatideapproved

Product authorisation ended — Byetta is indicated for treatment of type-2 diabetes mellitus in combination with: metfo… (2026)

Insulin Aspartapproved

Biosimilar approval — Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and child… (2026)

Insulin Glargineapproved

Biosimilar approval — Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. (2026)

Insulin Lisproapproved

Biosimilar approval — For the treatment of adults and children with diabetes mellitus who require insulin for t… (2026)

Repaglinideapproved

Product authorisation ended — Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes… (2026)

Telmisartanapproved

Product authorisation ended — Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Red… (2026)

Lixisenatideapproved

Product authorisation ended — Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve… (2025)

Dasiglucagon hydrochlorideapproved

Original application approval — Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents,… (2024)

Insulin icodecapproved

Original application approval — Treatment of diabetes mellitus in adults (2024)

Dapagliflozinapproved

Generic approval — Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 1… (2023)

Sitagliptin hydrochlorideapproved

Generic approval — For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to impr… (2022)

Tirzepatideapproved

Original application approval — Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults with insuffici… (2022)

Clinical trials

15 sponsors · 5 new · 0 completed in the last 12 months (net +4)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies

A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)

Phase 3 · Active, not recruiting · EyePoint Pharmaceuticals, Inc.

Beta Cell Function in Type 2 Diabetes in Black Patients: Differential Effects of SGLT2 Inhibitors and GLIP-Receptor Agonists

Phase 4 · Active, not recruiting · MaryAnn Banerji

EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)

Phase 3 · Active, not recruiting · Pfizer

A 96-week, Single-arm Study to Evaluate the Efficacy and Safety of 8mg Aflibercept in Subjects With Proliferative Diabetic Retinopathy (PDR) Without Center-involved Diabetic Macular Edema (DME)

Phase 4 · Active, not recruiting · Edward Wood, MD

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Phase 3 · Active, not recruiting · Eli Lilly and Company

A Randomized, Double-Masked, Multi-Center, 3-Arm Pivotal Phase 2/3 Study to Evaluate The Efficacy and Safety of Intravitreal EYE103 Compared With Intravitreal Ranibizumab (0.5mg) in Participants With Diabetic Macular Edema

Phase 2/3 · Active, not recruiting · EyeBiotech Ltd.
Recently completed

Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus

Phase 3 · Completed · Tanabe Pharma Corporation

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

Phase 3 · Completed · Alimera Sciences

Effect of Rubus Occidentalis Extract on Plasma Glucose Levels in Subject With Prediabetes; A Proof-of-concept, Randomized, Double-blind, Parallel-group Placebo-controlled Study

Phase 4 · Completed · Korea University Anam Hospital

A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control

Phase 3 · Completed · Boehringer Ingelheim

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin

Phase 3 · Completed · Boehringer Ingelheim

An Open-label, Randomized and Crossover Study to Assess the Effect of Co-administration of Vildagliptin and Voglibose on the Steady-state Pharmacokinetics / Pharmacodynamics in Japanese Patients With Type 2 Diabetes

Phase 4 · Completed · Novartis Pharmaceuticals

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

Product approvals and authorisations
2026emaBiosimilar approval — Insulin Lispro· For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Bysumlog is also indicated for the initial stabilisation of diabetes mellitus. source ↗
2026emaBiosimilar approval — Insulin Aspart· Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. source ↗
2026emaBiosimilar approval — Insulin Glargine· Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. source ↗
2024emaOriginal application approval — Dasiglucagon hydrochloride· Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus. source ↗
2024emaOriginal application approval — Insulin icodec· Treatment of diabetes mellitus in adults source ↗
2023emaGeneric approval — Dapagliflozin· Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Dapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. Chronic kidney disease Dapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease. source ↗
2022emaOriginal application approval — Tirzepatide· Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1. Weight management Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obesity) or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus). source ↗
2022emaGeneric approval — Sitagliptin hydrochloride· For adult patients with type 2 diabetes mellitus, Sitagliptin Accord is indicated to improve glycaemic control: as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.- a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.- a peroxisome proliferator-activated receptor gamma (PPARy) agonist (i.e. a thiazolidinedione) when use of a PPARy agonist is appropriate and when diet and exercise plus the PPARy agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.- a PPARy agonist and metformin when use of a PPARy agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. Sitagliptin Accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control. source ↗
Other regulatory activity
2026emaProduct authorisation ended — Repaglinide· Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. source ↗
2026emaProduct authorisation ended — Telmisartan· Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage. source ↗
2026emaProduct authorisation ended — Telmisartan· Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage. source ↗
2026emaProduct authorisation ended — Exenatide· Byetta is indicated for treatment of type-2 diabetes mellitus in combination with: metformin; sulphonylureas; thiazolidinediones; metformin and a sulphonylurea; metformin and a thiazolidinedione; in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents. source ↗
2026emaProduct authorisation ended — Exenatide· Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations). Bydureon is indicated for treatment of type 2 diabetes mellitus in combination with: Metformin Sulphonylurea Thiazolidinedione Metformin and sulphonylurea Metformin and thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. source ↗
2025emaProduct authorisation ended — Lixisenatide· Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. source ↗
2024emaProduct authorisation ended — Insulin Aspart· Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

112 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
2015–2026
Major themes8
  • Diabetes Mellitus39
  • Cardiovascular Diseases9
  • Gastrointestinal Microbiome7
  • Insulin Resistance5
  • Obesity5
  • Renal Insufficiency, Chronic5
  • COVID-194
  • Diabetes Complications3
Leading journals6
  • Diabetes care15
  • Endocrine reviews5
  • Frontiers in endocrinology5
  • Nutrients5
  • Cardiovascular diabetology4
  • Diabetologia3
Leading researchers8
  • Liu Y4
  • Bannuru RR3
  • ElSayed NA3
  • Gabbay RA3
  • Khunti K3
  • Aleppo G2
  • Aroda VR2
  • Brown FM2
Affiliations (unnormalised)6
  • Department of Clinical Medicine4
  • Emory University School of Medicine3
  • School of Medicine3
  • Charité Universitätsmedizin Berlin2
  • College of Pharmacy2
  • Diabetes Research Centre2

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

KCNJ110.79GCK0.78ABCC80.78PPARG0.74HNF1A0.73INSR0.72GLP1R0.71WFS10.66CACNA1D0.66NDUFS40.66ACE0.66HNF4A0.64

Disease biology

12 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

ATP-sensitive inward rectifier potassium channel 11via KCNJ110.79ATP-binding cassette sub-family C member 8via ABCC80.78Peroxisome proliferator-activated receptor gammavia PPARG0.74Hepatocyte nuclear factor 1-alphavia HNF1A0.73Insulin receptorvia INSR0.72Glucagon-like peptide 1 receptorvia GLP1R0.71Voltage-dependent L-type calcium channel subunit alpha-1Dvia CACNA1D0.66Angiotensin-converting enzymevia ACE0.66Dipeptidyl peptidase 4via DPP40.62Sodium/glucose cotransporter 2via SLC5A20.62Voltage-dependent L-type calcium channel subunit alpha-1Cvia CACNA1C0.62Alpha-ketoglutarate-dependent dioxygenase FTOvia FTO0.61

Related conditions

12 matches

Diseases frequently studied alongside this one. Number shows shared papers.

Obesity32Cardiovascular Diseases21COVID-1912Diabetes Complications12Insulin Resistance12Neoplasms12Hypertension11Diabetes Mellitus, Type 29Inflammation9Renal Insufficiency, Chronic9Hyperglycemia8Neurodegenerative Diseases7

Showing the 12 strongest of 50 by shared papers — weaker co-mentions are not shown.

Disease profile

A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.

Overview

Diabetes mellitus is a heterogeneous group of disorders characterized by hyperglycemia and impaired glucose tolerance. The supplied material also treats it as a chronic metabolic disease that is clinically classified, diagnosed, and managed across type 1 and type 2 diabetes.

Causes

The grounding supports a multifactorial etiology rather than a single cause. It links diabetes to obesity-associated chronic low-grade inflammation, metabolic-immune interactions, and genetic mechanisms, and it also includes microbiologic and endocrine factors in the literature coverage.

Pathophysiology

The literature describes diabetes as arising from disrupted metabolic and inflammatory signaling that contributes to hyperglycemia. Mechanistic themes include oxidative stress, apoptosis, signal transduction changes, altered glucose transport, advanced glycation-related pathways, and interactions involving the renin-angiotensin system and gastrointestinal microbiome.

Risk factors

Obesity is supported as a risk factor through its association with chronic low-level inflammation and diabetes-related metabolic dysfunction. Depression is also associated with hyperglycemia and increased risk for diabetic complications in the supplied abstracts.

Current standard of care

Management is described at the level of therapeutic lifestyle changes and medical therapy for hyperglycemia. The grounding supports insulin-based treatment and newer glucose-lowering drug classes including GLP-1 receptor agonists such as liraglutide and exenatide, with diabetes also treated within broader cardiovascular risk management frameworks.

AI-generated summary grounded in MeSH and 6 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.

Identifiers
MeSHDiabetes Mellitus
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.