Clinical trials: T1DM
Type 1 Diabetes Mellitus
A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM
This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e.
- Trial name
- NCT03176524
- Testing
- BioChaperone® glucagon formulation 1, BioChaperone® glucagon formulation 2, GlucaGen® HypoKit®
- Where
- Germany
- Volunteers
- 27 people
- Sponsor
- Adocia
Diabetes Mellitus, Type 1
Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
Primary Objective: •To evaluate equivalence of Gan \& Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin…
- Trial name
- GLITTER1 (NCT03371082)
- Testing
- Gan & Lee Insulin Glargine Injection, Lantus®
- Where
- 85 sites in United States, Czechia and 4 more
- Volunteers
- 576 people
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Hypoglycemia, Diabetes Mellitus, Type 1
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection [rDNA origin]) for hypoglycemia rescue of adult patients with type 1…
- Trial name
- NCT02656069
- Testing
- G-Pen (glucagon injection), Lilly Glucagon (glucagon injection [rDNA origin])
- Where
- 7 sites in United States, Canada
- Volunteers
- 80 people
- Sponsor
- Xeris Pharmaceuticals
Diabetes Mellitus, Type 1
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2
DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo.
- Trial name
- DEFEND-2 (NCT01123083)
- Testing
- Otelixizumab
- Where
- Italy
- Volunteers
- 179 people
- Sponsor
- GlaxoSmithKline
Type 1 Diabetes
A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus
VC01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.
- Trial name
- VC01-103 (NCT04678557)
- Testing
- VC-01 Combination Product
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- ViaCyte
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
Tolerability, Safety, and Efficacy Study of INGAP Peptide to Treat Type 1 Diabetes Mellitus in Adults
INGAP Peptide acetate is the active ingredient of INGAP Peptide Solution for Injection. It is being developed as an antidiabetic agent for the restoration of endogenous insulin secretion in patients with type 1 diabetes mellitus…
- Trial name
- NCT00995540
- Testing
- INGAP Peptide
- Where
- 2 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Exsulin Corporation
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
Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus
The purpose of this two-part multiple ascending dose study is to evaluate the safety and tolerability of multiple doses of MHS552 in adults with type 1 diabetes mellitus.
- Trial name
- NCT05272059
- Testing
- MHS552
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type 1, Type 1 Diabetes
Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")
This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer…
- Trial name
- NCT04398030
- Testing
- coil-reinforced soft polymer indwelling cannula, soft Teflon indwelling catheter
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Capillary Biomedical, Inc.
Healthy, Type 1 Diabetes Mellitus
A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)
The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it.
- Trial name
- NCT06280703
- Testing
- LY3938577, Insulin Degludec, Insulin Lispro
- Where
- Germany
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus, Type 1
Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro
Primary Objective: To compare the immunogenicity of Gan \& Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM Secondary Objectives: To evaluate the safety of Gan \& Lee Insulin…
- Trial name
- GENTL 1 (NCT04254380)
- Testing
- Gan & Lee Insulin Lispro Injection, Humalog
- Where
- 107 sites in United States, Czechia and 4 more
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Type 1 Diabetes Mellitus
Concurrent Use of Two Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus (T1DM)
The purpose of this pilot study is to evaluate performance of the SEVEN System and the Navigator System when both devices are worn concurrently by subjects with type 1 diabetes mellitus.
- Trial name
- NCT00939289
- Testing
- Continuous Glucose Monitoring
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- DexCom, Inc.
Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
- Trial name
- inTandem3 (NCT02531035)
- Testing
- Sotagliflozin
- Where
- 135 sites in United States, Argentina and 17 more
- Volunteers
- 1,405 people
- Sponsor
- Lexicon Pharmaceuticals
Hypoglycemia, Diabetes Mellitus, Type 1
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo
- Trial name
- NCT03688711
- Testing
- Dasiglucagon
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Zealand Pharma
Type 1 Diabetes Mellitus
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).
- Trial name
- NCT00870818
- Testing
- Blood samples for safety, Patient reported outcome questionnaires, Analysis of T-cell subsets
- Where
- United States
- Volunteers
- 219 people
- Sponsor
- MacroGenics
Type1 Diabetes Mellitus
BOL-DP-o-05 as an Add-On Treatment of Subjects With Newly Diagnosed Type 1 Diabetes Mellitus
BOL-DP-o-05 as an Add-On Treatment for Preservation of Beta-Cell Function in Subjects With Newly-Diagnosed Type 1 Diabetes Mellitus (T1DM)
- Trial name
- NCT04102202
- Testing
- BOL-DP-o-05
- Sponsor
- Breath of Life International Pharma Ltd
Treatment of Type I Diabetes Mellitus.
Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy
Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type I Diabetes Mellitus (T1DM) patients.
- Trial name
- NCT01947569
- Testing
- Biological
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- DiaVacs, Inc.
Diabetes Mellitus, Type 1
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.
- Trial name
- NCT07222332
- Testing
- Baricitinib
- Where
- 131 sites in United States, Australia and 18 more
- Volunteers
- 300 people
- Sponsor
- Eli Lilly and Company
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