Type 1 Diabetes Mellitus

Metabolic Diseases
33
Pipeline Programs
25
Companies
50
Clinical Trials
8 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
6
12
1
6
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
240%
Small Molecule
240%
Peptide
120%
+ 45 programs with unclassified modality

On Market (2)

Approved therapies currently available

U
DAPAGLIFLOZINApproved
dapagliflozin
Unknown Company
AstraZeneca
FARXIGAApproved
dapagliflozin
AstraZeneca
oral2014

Competitive Landscape

25 companies ranked by most advanced pipeline stage

AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
1
Dapagliflozin 5mgPhase 11 trial
Active Trials
NCT02582840Completed42Est. Jun 2016
Pfizer
PfizerNEW YORK, NY
1 program
1
ExuberaPhase 45 trials
Active Trials
NCT00734591Completed7,439Est. Jan 2012
NCT00479258Terminated2Est. Oct 2007
NCT00437489Terminated49Est. Dec 2007
+2 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
6 programs
1
3
LY2605541Phase 32 trials
LY900014Phase 31 trial
Teplizumab Herold RegimenPhase 31 trial
LY2605541Phase 11 trial
AID SystemN/A1 trial
+1 more programs
Active Trials
NCT03743285Completed10Est. Jan 2019
NCT01787903Completed52Est. Apr 2016
NCT01925989Completed27Est. Oct 2015
+4 more trials
Sanofi
SanofiPARIS, France
4 programs
1
2
1
SotagliflozinPhase 3Small Molecule1 trial
FrexalimabPhase 2Monoclonal Antibody1 trial
TeplizumabPhase 2Monoclonal Antibody5 trials
Insulin glargine HOE901Phase 11 trial
Active Trials
NCT01349855Completed30Est. May 2011
NCT06111586Recruiting192Est. Oct 2030
NCT07360080Not Yet Recruiting1,000Est. Oct 2035
+5 more trials
Diamyd Medical
Diamyd MedicalSweden - Stockholm
2 programs
1
1
Recombinant human glutamic acid decarboxylasePhase 31 trial
Gamma-Aminobutyric AcidPhase 1/21 trial
Active Trials
NCT03635437Completed35Est. Sep 2022
NCT05018585Active Not Recruiting330Est. Dec 2027
Bristol Myers Squibb
1 program
1
DapagliflozinPhase 3Small Molecule
Beta Bionics
Beta BionicsIRVINE, CA
1 program
1
Bihormonal iLet Bionic PancreasPhase 2/31 trial
Active Trials
NCT03840278Completed12Est. Jul 2019
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
4 programs
4
Allogeneic Pancreatic Islet CellsPhase 21 trial
Allogeneic Pancreatic Islet CellsPhase 21 trial
CTLA-4 IgPhase 21 trial
GAD-AlumPhase 21 trial
Active Trials
NCT00468403CompletedEst. Apr 2013
NCT00468442TerminatedEst. Sep 2011
NCT00505375CompletedEst. May 2012
+1 more trials
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
3 programs
2
A highly hydrolyzed formulaPhase 21 trial
LiraglutidePhase 2Peptide1 trial
Insulin Aspart versus Insulin LisproN/A1 trial
Active Trials
NCT00428207Terminated4Est. Aug 2008
NCT00570102Completed230Est. Jan 2008
NCT02408705Completed14Est. May 2016
Eledon Pharmaceuticals
2 programs
1
1
AT-1501Phase 21 trial
Islet transplantation with TegoprubartPhase 1/2
Active Trials
NCT04711226WithdrawnEst. Jun 2026
Grifols
GrifolsNEW YORK, NY
1 program
1
180 mg/kg Alpha1-PIPhase 21 trial
Active Trials
NCT02093221TerminatedEst. Jun 2017
Fusion Pharmaceuticals Inc.
1 program
1
BMF-219Phase 21 trial
Active Trials
NCT06152042TerminatedEst. Jul 2025
Biomea Fusion
Biomea FusionSAN CARLOS, CA
1 program
1
BMF-219Phase 2
Avotres
AvotresNJ - Cedar Knolls
1 program
1
AVT001Phase 1/21 trial
Active Trials
NCT03895996CompletedEst. Dec 2023
COUR Pharmaceuticals
1 program
1
CNP-103Phase 1/21 trial
Active Trials
NCT06783309RecruitingEst. Jun 2027
Alliance Pharmaceuticals
1 program
1
Islet transplantation with TegoprubartPhase 1/21 trial
Active Trials
NCT06305286Recruiting70Est. Mar 2029
Sernova Biotherapeutics
1 program
1
Sernova Cell PouchPhase 1/21 trial
Active Trials
NCT03513939Active Not Recruiting17Est. Oct 2026
M&
Merck & Co.RAHWAY, NJ
2 programs
2
MK-1293Phase 13 trials
MK-2640Phase 11 trial
Active Trials
NCT02059187Completed531Est. Mar 2015
NCT02059174Completed76Est. Apr 2015
NCT02059161Completed508Est. Nov 2015
+1 more trials
Insulet
InsuletACTON, MA
7 programs
Closed Loop ControlN/A
Heart rate informed SSM+HMMN/A
Insulet APN/A1 trial
Omnipod Horizon™ Automated Glucose Control SystemN/A1 trial
Omnipod Horizon™ Automated Glucose Control SystemN/A1 trial
+2 more programs
Active Trials
NCT03064906CompletedEst. Apr 2017
NCT04476472CompletedEst. Oct 2022
NCT04176731CompletedEst. Jan 2020
+1 more trials
Roche
RocheSTAVANGER NORWAY, Norway
2 programs
Accu-Chek SmartGuide CGM SolutionN/A1 trial
t:slim X2 with Control-IQ Technology & Dexcom G6 CGMN/A1 trial
Active Trials
NCT06704672Recruiting270Est. Dec 2026
NCT03563313Completed168Est. Apr 2019
Verona Pharma
Verona PharmaUK - London
2 programs
Clamp-Mixed MealN/A1 trial
Tandem t:slim X2 with Control-IQ technologyN/A1 trial
Active Trials
NCT02003274Unknown20Est. Oct 2017
NCT06876207RecruitingEst. Jun 2026
Abbott
AbbottABBOTT PARK, IL
2 programs
Heart rate informed SSM+HMMN/A1 trial
Sensor Based Glucose Monitoring SystemN/A2 trials
Active Trials
NCT01582139Completed12Est. Aug 2012
NCT02232698Completed328Est. Oct 2015
NCT02082184Completed302Est. Dec 2015
Glooko
GlookoCA - Palo Alto
1 program
CamAPS FXN/A1 trial
Active Trials
NCT03784027CompletedEst. Oct 2022
Alder Therapeutics
Alder TherapeuticsSweden - Solna
1 program
CamAPS FX using faster insulin aspartN/A1 trial
Active Trials
NCT04759144Completed27Est. Dec 2022
Luna Diabetes
Luna DiabetesCA - San Diego
1 program
Episodic overnight patch pumpN/A1 trial
Active Trials
NCT06627517Active Not RecruitingEst. Dec 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
SanofiTeplizumab
PfizerExubera
PfizerExubera
PfizerExubera
PfizerExubera
PfizerExubera
PfizerExubera
PfizerExubera
SanofiTeplizumab
Diamyd MedicalRecombinant human glutamic acid decarboxylase
Eli Lilly and CompanyLY900014
SanofiSotagliflozin
Merck & Co.MK-1293
Merck & Co.MK-1293
Eli Lilly and CompanyLY2605541

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 11,067 patients across 50 trials

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Start: Jul 2023Est. completion: Aug 202620 patients
Phase 4Active Not Recruiting

A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

Start: Jun 2007Est. completion: Dec 200749 patients
Phase 4Terminated

This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

Start: Mar 2007Est. completion: Aug 2008413 patients
Phase 4Completed

A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

Start: Dec 2006Est. completion: Aug 2008261 patients
Phase 4Completed

A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

Start: Nov 2006Est. completion: Jun 200858 patients
Phase 4Terminated

A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus

Start: Sep 2006Est. completion: Feb 200730 patients
Phase 4Completed

Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety

Start: Jul 2006Est. completion: Apr 20091,976 patients
Phase 4Completed

Study to Estimate the Effects of Inhaled Versus Intravenous (IV) Infusion of Human Insulin in Subjects With Type 1 Diabetes

Start: Apr 2006Est. completion: Dec 200612 patients
Phase 4Completed

A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes

Start: Aug 2025Est. completion: Dec 2028723 patients
Phase 3Recruiting
NCT05018585Diamyd MedicalRecombinant human glutamic acid decarboxylase

A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes

Start: May 2022Est. completion: Dec 2027330 patients
Phase 3Active Not Recruiting

A Study of LY900014 in Participants With Type 1 Diabetes

Start: Jul 2017Est. completion: Aug 20191,392 patients
Phase 3Completed
NCT02421510SanofiSotagliflozin

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Start: May 2015Est. completion: Jun 2017782 patients
Phase 3Completed

The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)

Start: Feb 2014Est. completion: Mar 2015531 patients
Phase 3Completed

A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)

Start: Oct 2013Est. completion: Nov 2015508 patients
Phase 3Completed

A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus

Start: Feb 2013Est. completion: Apr 2014212 patients
Phase 3Completed
NCT00920582Eli Lilly and CompanyTeplizumab Herold Regimen

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Start: Sep 2009Est. completion: Jul 2012254 patients
Phase 3Terminated

Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents

Start: Oct 2007Est. completion: Oct 20072 patients
Phase 3Terminated

Exubera vs Lispro in a Lantus-based Regimen for Improved Glycemic Control in Type 2 Diabetes

Start: Jun 2006Est. completion: Aug 2008191 patients
Phase 3Completed

Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes

Start: Sep 1999Est. completion: Dec 2000300 patients
Phase 3Completed
NCT03840278Beta BionicsBihormonal iLet Bionic Pancreas

The Bihormonal iLet Bionic Pancreas Feasibility Study

Start: May 2019Est. completion: Jul 201912 patients
Phase 2/3Completed

Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes

Start: Jul 2025Est. completion: Mar 202810 patients
Phase 2Recruiting

Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus

Start: Dec 2023Est. completion: Jul 2025
Phase 2Terminated

FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

Start: Dec 2023Est. completion: Oct 2030192 patients
Phase 2Recruiting

Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Islet Cell Transplantation

Start: Feb 2021Est. completion: Jun 2026
Phase 2Withdrawn

At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)

Start: Feb 2020Est. completion: Jan 20246 patients
Phase 2Completed

Investigating the Effect of Liraglutide on the Endogenous Glucose Production During in Tye 1 Diabetes Subjects

Start: Jan 2015Est. completion: May 201614 patients
Phase 2Completed
NCT02093221Grifols180 mg/kg Alpha1-PI

Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus

Start: Mar 2014Est. completion: Jun 2017
Phase 2Terminated

Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects

Start: Feb 2009Est. completion: May 2012
Phase 2Completed
NCT00468403Allergy TherapeuticsAllogeneic Pancreatic Islet Cells

LEA29Y (Belatacept) Emory Edmonton Protocol

Start: Oct 2008Est. completion: Apr 2013
Phase 2Completed

Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus

Start: Feb 2008Est. completion: May 2012
Phase 2Completed
NCT00468442Allergy TherapeuticsAllogeneic Pancreatic Islet Cells

B-Lymphocyte Immunotherapy in Islet Transplantation

Start: Nov 2006Est. completion: Sep 2011
Phase 2Terminated

Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus

Start: Mar 2003Est. completion: Jan 2008173 patients
Phase 2Terminated
NCT00570102Novo NordiskA highly hydrolyzed formula

Nutritional Prevention Pilot Trial for Type 1 Diabetes

Start: Feb 1995Est. completion: Jan 2008230 patients
Phase 2Completed

CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)

Start: May 2025Est. completion: Jun 2027
Phase 1/2Recruiting
NCT06305286Alliance PharmaceuticalsIslet transplantation with Tegoprubart

Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D)

Start: Mar 2024Est. completion: Mar 202970 patients
Phase 1/2Recruiting

Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes

Start: Jun 2019Est. completion: Dec 2023
Phase 1/2Completed

A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation

Start: Feb 2019Est. completion: Oct 202617 patients
Phase 1/2Active Not Recruiting
NCT03635437Diamyd MedicalGamma-Aminobutyric Acid

Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes

Start: Sep 2018Est. completion: Sep 202235 patients
Phase 1/2Completed
NCT02582840AstraZenecaDapagliflozin 5mg

The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM

Start: Oct 2015Est. completion: Jun 201642 patients
Phase 1Completed

A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)

Start: Nov 2014Est. completion: Jul 201674 patients
Phase 1Completed

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)

Start: Feb 2014Est. completion: Apr 201576 patients
Phase 1Completed

A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics

Start: Nov 2013Est. completion: Oct 201527 patients
Phase 1Completed

A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes

Start: Feb 2013Est. completion: Dec 201325 patients
Phase 1Completed
NCT01349855SanofiInsulin glargine HOE901

Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

Start: Mar 2011Est. completion: May 201130 patients
Phase 1Completed

Long-Term Outcomes of Teplizumab in Routine Clinical Care

Start: Mar 2026Est. completion: Oct 20351,000 patients
N/ANot Yet Recruiting

Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

Start: Mar 2026Est. completion: Nov 202660 patients
N/ANot Yet Recruiting

A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States

Start: Oct 2025Est. completion: Dec 2030550 patients
N/ARecruiting
NCT06876207Verona PharmaTandem t:slim X2 with Control-IQ technology

Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity

Start: Jun 2025Est. completion: Jun 2026
N/ARecruiting
NCT06704672RocheAccu-Chek SmartGuide CGM Solution

Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus

Start: Apr 2025Est. completion: Dec 2026270 patients
N/ARecruiting

Description of Patients With Type 1 Diabetes Treated With Teplizumab

Start: Feb 2025Est. completion: Aug 2025110 patients
N/ACompleted

Related Jobs in Metabolic Diseases

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

6 late-stage (Phase 3) programs — potential near-term approvals
8 actively recruiting trials targeting 11,067 patients
25 companies competing in this space