Clinical trials: Diabetes Type I
Type 1 Diabetes Mellitus
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
This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with…
- Trial name
- inTandem1 (NCT02384941)
- Testing
- Sotagliflozin
- Where
- 75 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Lexicon Pharmaceuticals
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Afrezza® Dosing Optimization Study
MKC-TI-191 is a Phase 4, single-arm, multicenter, proof-of-concept clinical trial evaluating the efficacy and safety of Afrezza, administered according to the current Afrezza prescribing information (PI) compared to a titrated…
- Trial name
- DOS (NCT04849845)
- Testing
- Afrezza Dose 1, Afrezza Dose 2
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Mannkind Corporation
Intermediate Stage of Hepatocellular Carcinoma, Hepatocellular Carcinoma
CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab
The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.
- Trial name
- NCT03638141
- Testing
- Durvalumab, Tremelimumab
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Type 1 Diabetes
Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children
The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically.
- Trial name
- PSO4 (NCT01823341)
- Testing
- Pump suspension algorithm
- Where
- 3 sites in United States, Canada
- Volunteers
- 97 people
- Sponsor
- Jaeb Center for Health Research
Type 1 Diabetes Mellitus
Adherence to Guidelines VAccination in Type 1 DIabetes Mellitus Patients (AVADI-1).
Observational study about adherence to guidelines for Influenza, Pneumococcal and Hepatitis B Vaccination in adult patients with type 1 Diabetes mellitus.
- Trial name
- AVADI-1 (NCT03478254)
- Testing
- Influenza vaccination, Pneumococcal vaccination, Hepatitis B Virus (HBV) vaccination
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Jesús Moreno Fernández
Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia
Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes
Almost all people who have had type 1 diabetes for 5 years have a defect in secretion of the hormone Glucagon. This hormone is involved in the body's response to low blood glucose (hypoglycaemia).
- Conditions
- Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia, Hypoglycemia, Hypoglycemia Unawareness
- Trial name
- NCT04614168
- Testing
- Stepped hyperinsulinaemic-hypoglycaemic clamp study, Insulin pump, Continuous glucose monitor
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- University of Edinburgh
Primary Biliary Cirrhosis
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment with ursodeoxycholic acid (UDCA, Urso, Ursodiol…
- Trial name
- PBC (NCT02078882)
- Testing
- abatacept
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Christopher Bowlus, MD
Type 1 Diabetes Mellitus
Outpatient Control-to-Range: System and Monitoring Testing
A single arm, single treatment study is proposed to assess the feasibility of the AP Platform (cell phone + Control to Range system) outside of a hospital based clinical research center.
- Trial name
- NCT01578980
- Testing
- Outpatient Control-to-Range
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Virginia
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
Type 1 Diabetes
Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes
Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group.
- Trial name
- NCT00406133
- Testing
- Continuous glucose monitor
- Where
- 11 sites in United States
- Volunteers
- 451 people
- Sponsor
- Jaeb Center for Health Research
Hypoglycemia Unawareness
Carvedilol in Treating Hypoglycemia Unawareness
Type 1 diabetes mellitus (T1DM) can lead to cardiovascular, renal and neurological complications if left poorly-controlled over prolonged periods of time.
- Trial name
- NCT03538015
- Testing
- Carvedilol 3.125 mg, Carvedilol 2.5 mg
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Owen Chan, PhD
Type 1 Diabetes Mellitus
The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.
- Trial name
- NCT00913497
- Testing
- insulin glulisine, insulin aspart
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Corewell Health West
Type 1 Diabetes Mellitus
Continuous Glucose Monitoring to Measure Effect of Glycemic Index
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes. Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify…
- Trial name
- NCT01145547
- Testing
- Dexcom Seven® Plus Continuous Glucose Monitoring sensor
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Legacy Health System
Diabetes Mellitus, Type 1
Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days
Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days.
- Trial name
- NCT01969747
- Testing
- Empagliflozin medium, Empagliflozin low
- Where
- 2 sites in Austria, Germany
- Volunteers
- 75 people
- Sponsor
- Boehringer Ingelheim
Type 1 Diabetes
Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone
This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system.
- Trial name
- NCT00797823
- Testing
- Insulin, Asp(B28)-, Glucagon
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Legacy Health System
Type1diabetes
IN Insulin in Type 1 Diabetes (T1D) Hypoglycemia Unawareness: Safety Only Phase
The purpose of this study is to determine how Humulin-R regular insulin affects the body's ability to feel low blood sugar (hypoglycemia) when delivered intranasally compared to placebo in subjects with Type 1 Diabetes (T1D) with…
- Trial name
- NCT04028960
- Testing
- Regular insulin (Humulin-R), intranasal route, SipNose intranasal device
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- HealthPartners Institute
Autoantibody Positive, Non-diabetic Relatives at Risk for Type 1 Diabetes
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very high risk for developing the disease.
- Conditions
- Autoantibody Positive, Non-diabetic Relatives at Risk for Type 1 Diabetes, High Risk, Impaired Glucose Tolerance
- Trial name
- NCT01030861
- Testing
- Teplizumab
- Where
- 19 sites in United States, Canada and 1 more
- Volunteers
- 76 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 1 Diabetes
The International Diabetes Closed Loop (iDCL) Trial: Protocol 4
The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.
- Trial name
- DCLP4 (NCT04436796)
- Testing
- interoperable Artificial Pancreas System (iAPS), Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sansum Diabetes Research Institute
Type 1 Diabetes
Closed-Loop Glucagon Administration For Hypoglycemia Treatment
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes > 21 years old.
- Trial name
- NCT02181127
- Testing
- Glucagon-only Bionic Pancreas
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Type 1 Diabetes
Equivalence of A Stable Liquid Glucagon Formulation With Freshly Reconstituted Lyophilized Glucagon
This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).
- Trial name
- NCT02018627
- Testing
- Xeris glucagon, Lilly glucagon
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Steven J. Russell, MD, PhD