Clinical trials: T1DM
Hypoglycemia
Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes
The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of…
- Trial name
- NCT02081014
- Testing
- G-Pen Mini™ (glucagon injection)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes Mellitus
Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes
This study will determine 1) the safety of AC2993 in patients with type I diabetes; 2) the ability of AC2993 to improve beta cell function; and 3) the effects of immunosuppression on beta cell function.
- Trial name
- NCT00064714
- Testing
- AC2993 (exenatide), daclizumab (immunosuppressive)
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 1
AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study
Phase 1 randomized, double-blind, three period, crossover study comparing the pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid insulin aspart (AT247), NovoLog® and Fiasp® in participants…
- Trial name
- NCT05184868
- Testing
- AT247, NovoLog, Fiasp
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Arecor Limited
Type 1 Diabetes
Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes
Primary Objective: To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics. Secondary Objectives: To document the profile of Type 1 diabetes patients.
- Trial name
- SHINE (NCT03312478)
- Testing
- Blood draw for insulin auto-anti body tests*
- Where
- Pakistan
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 1 Diabetes Mellitus
Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
This is a prospective, single arm, open-label, interventional, pilot study to evaluate the accuracy and precision of the continuous glucose monitoring (CGM) system of i-SENS, Inc., CareSens Air 3, in adult patients with type 1…
- Trial name
- Air3Pilot (NCT07296276)
- Testing
- CareSens Air 3 primary insertion, CareSens Air 3 secondary insertion
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- i-SENS, Inc.
Diabetes Mellitus, Type 1
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating.
- Trial name
- NCT04276207
- Testing
- LY900014, Insulin Lispro
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Type 1 Diabetes Mellitus (T1DM)
Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil
Multi-centre, open label, multiple ascending dose trial in patients with type 1 diabetes mellitus
- Trial name
- NCT04141423
- Testing
- Tregopil
- Where
- Germany
- Volunteers
- 55 people
- Sponsor
- Biocon Limited
Diabetes Mellitus, Type 1
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo infusion.
- Trial name
- DEFEND-1 (NCT00678886)
- Testing
- otelixizumab infusion plus physician determined standard of care
- Where
- 109 sites in United States, Canada and 7 more
- Volunteers
- 272 people
- Sponsor
- GlaxoSmithKline
Type 1 Diabetes Mellitus
Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion
Primary Objective: Assess the safety of SAR342434 and Humalog when used in external pumps. Secondary Objectives: Intervals for infusion set changes. Incidence of insulin pump alarms for infusion set occlusion.
- Trial name
- NCT02603510
- Testing
- SAR342434, insulin lispro
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Sanofi
Type 1 Diabetes, Pancreatectomy; Hyperglycemia
Collection of Human Liver Biopsy and Whole Blood Samples From T1DM, TP or PP Patients for Potential Use for Insulin Producing Cells in Future Clinical Studies
In this study, liver samples will be collected, processed and stored in a specialized, clinical grade, cell bank for potential future clinical use.
- Trial name
- NCT04038931
- Testing
- Liver biopsy collection
- Volunteers
- 20 people
- Sponsor
- Orgenesis Ltd.
Diabetes Mellitus
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470
The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.
- Trial name
- NCT02302443
- Testing
- HM12470, Active comparator
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Type 1 Diabetes Mellitus
Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
Primary Objective: To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms of the number of patients with infusion set occlusions.
- Trial name
- NCT03436498
- Testing
- Insulin aspart SAR341402, Insulin aspart
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Sanofi
Hypoglycemia, Diabetes Mellitus, Type 1
A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
A randomized, double-blind, crossover trial to compare the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with type 1 diabetes mellitus (T1DM)
- Trial name
- NCT03895697
- Testing
- dasiglucagon
- Where
- Canada
- Volunteers
- 92 people
- Sponsor
- Zealand Pharma
Diabetes Mellitus, Diabetes Mellitus, Type 1
An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D
This is an open-label, multicenter, Phase 1 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease
- Trial name
- NCT05565248
- Testing
- VCTX211
- Where
- 2 sites in Canada
- Volunteers
- 5 people
- Sponsor
- CRISPR Therapeutics AG
Type 1 Diabetes Mellitus
A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)
In this trial, the treatment of subjects with type 1 diabetes with M1 Pram P037 as co-formulation of pramlintide and A21G human insulin analogue product will be compared with a current standard treatment, insulin lispro.
- Trial name
- NCT04816890
- Testing
- M1 Pram P037, Insulin lispro
- Where
- 2 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Adocia
Diabetes Mellitus
Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM.
- Trial name
- NCT02691247
- Testing
- CLBS03 Low Dose, CLBS03 High Dose
- Where
- 15 sites in United States
- Volunteers
- 113 people
- Sponsor
- Lisata Therapeutics, Inc.
Type 1 Diabetes Mellitus
Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects
The study was a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on…
- Trial name
- CCFZ533X2207 (NCT04129528)
- Testing
- CFZ533
- Where
- 12 sites in Belgium, Germany and 4 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Type 1 Diabetes Mellitus, T1D
CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)
This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103.
- Conditions
- Type 1 Diabetes Mellitus, T1D, T1DM, T1DM - Type 1 Diabetes Mellitus
- Trial name
- NCT06783309
- Testing
- CNP-103
- Where
- 45 sites in United States
- Volunteers
- 72 people
- Sponsor
- COUR Pharmaceutical Development Company, Inc.
Type 1 Diabetes Mellitus (T1DM)
The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.
The goal of this randomized controlled study is to assess the clinical performance and safety of Hedia Diabetes Assistant in adults with type 1 diabetes and suboptimal glycemic control in France.
- Trial name
- TEMPO (NCT06819306)
- Testing
- Hedia Diabetes Assistant
- Where
- 6 sites in France
- Volunteers
- 154 people
- Sponsor
- Hedia ApS
Diabetes Mellitus, Type 1, Hypoglycemia
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the…
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia, Islet Cell Transplantation, Type 1 Diabetes
- Trial name
- NCT06575426
- Testing
- OPF-310
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Otsuka Pharmaceutical Factory, Inc.