Clinical trials: T1DM
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
The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
This study will enroll eligible subjects into a long-term safety study (Part B). Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5%…
- Trial name
- NCT02582814
- Testing
- Dapagliflozin 5 mg, Dapagliflozin 10mg
- Where
- 24 sites in Japan
- Volunteers
- 151 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 Mellitus, Pregnancy
Orchestra Pregnancy Observational Study in Poland
The aim of this project is to document the use of insulin pump therapy (CSII), including sensor augmented pump therapy (SAP), before, during and after pregnancy in women with type 1 Diabetes Mellitus benefiting from the Orchestra…
- Trial name
- NCT01779141
- Where
- 24 sites in Poland
- Volunteers
- 481 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes Mellitus
The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate glycemic control on insulin defined as HbA1c ≥…
- Trial name
- NCT02582840
- Testing
- Dapagliflozin 5mg, Dapagliflozin 10mg
- Where
- Japan
- Volunteers
- 42 people
- Sponsor
- AstraZeneca
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.
Type 1 Diabetes Mellitus
PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)
Primary Objective: To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp…
- Trial name
- NCT02485327
- Testing
- Technosphere Insulin SAR439065 Afrezza®
- Where
- Germany
- Volunteers
- 22 people
- Sponsor
- Mannkind Corporation
Type 1 Diabetes Mellitus
A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)
The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior…
- Trial name
- NCT02059161
- Testing
- MK-1293, Lantus™, Prandial Insulin
- Volunteers
- 508 people
- Sponsor
- Merck Sharp & Dohme LLC
Type 1 Diabetes Mellitus
Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)
Primary Objective: To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.
- Trial name
- NCT01053728
- Testing
- SAR161271, Insulin glargine HOE901
- Where
- Germany
- Volunteers
- 46 people
- Sponsor
- Sanofi
Diabetes Mellitus, Type 1
Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With T1DM (EASE-3)
The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin
- Trial name
- NCT02580591
- Testing
- Empagliflozin
- Where
- 189 sites in United States, Australia and 22 more
- Volunteers
- 977 people
- Sponsor
- Boehringer Ingelheim