Clinical trials: T1DM
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.
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
Type 1 Diabetes Mellitus
Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)
The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20) will change the exposure and action of approved insulin analogs when given by continuous subcutaneous insulin infusion (CSII) in…
- Trial name
- NCT01275131
- Testing
- Insulin aspart, Recombinant human hyaluronidase PH20 (rHuPH20)
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Halozyme Therapeutics
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
Hypoglycemia
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy…
- Trial name
- NCT03667053
- Testing
- dasiglucagon, GlucaGen HypoKit
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 42 people
- Sponsor
- Zealand Pharma
Diabetes Mellitus, Type 1, Type 1 Diabetes
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days.
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes Mellitus, Insulin-Dependent, 1
- Trial name
- FEXIS (NCT04503564)
- Testing
- coil-reinforced soft polymer indwelling cannula
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Capillary Biomedical, Inc.
Type 1 Diabetes Mellitus
Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
The aim of this extension study is to assess the safety and efficacy of Mylan's insulin glargine and Lantus® in T1DM patients.
- Trial name
- NCT02666430
- Testing
- Mylan's insulin glargine, Lantus®
- Where
- 81 sites in United States, Canada and 6 more
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Diabetes Mellitus, Type 1
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar.
- Trial name
- NCT03341299
- Testing
- LY900014, Insulin Lispro
- Where
- 2 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Eli Lilly and Company
Diabetes Mellitus, Type 1
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).
- Trial name
- NCT02139943
- Testing
- Canagliflozin 100 mg, Canagliflozin 300 mg
- Where
- 53 sites in United States, Canada
- Volunteers
- 352 people
- Sponsor
- Janssen Research & Development, LLC
Hypoglycemia, Diabetes Mellitus, Type 1
A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate…
- Trial name
- NCT03216226
- Testing
- dasiglucagon, GlucaGen
- Where
- 7 sites in United States, Austria and 2 more
- Volunteers
- 112 people
- Sponsor
- Zealand Pharma
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, 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
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
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
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