Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus
Type 1 DiabetesHypoglycemiaThe purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may thus reduce the occurrence of hypoglycemia. Approximately 25 participants with well-controlled type 1 diabetes will be recruited to a crossover study and be randomized to the order in which they receive a single administration of placebo, low dose and high dose ZT-01 during three euglycemic-hypoglycemic clamps 2 to 6 weeks apart, with a follow-up visit approximately 1 week after the final clamp. Participants will stay overnight in the clinic before each clamp, and their plasma glucose (PG) will be kept at euglycemic levels with IV insulin and dextrose as needed. The following morning, the clamp will begin and the subject's PG will be kept at 5.5 mmol/L (euglycemia) with variable IV insulin (and dextrose as needed). Study treatment will be administered during this euglycemic period, and then insulin will be increased so that PG falls to a plateau of mild hypoglycemia, and then increased further to clinically significant hypoglycemia. Release of glucagon and other counterregulatory hormones will be measured, and a symptom score will be completed, during euglycemia before and following study treatment, and during each level of hypoglycemia. Following the clamp, the participant's blood glucose will be returned to normal levels prior to leaving the clinic.
Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma
DiabetesDiabetes Mellitus4 moreThis trial is conducted in Europe, Asia, Oceania and the United States of America (USA). This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.
Long-Term Safety Study Of Inhaled Insulin (CP-464,005, Inhaler) In Japanese Patients With Type1...
Diabetes MellitusType 22 moreAssess the safety and toleration of CP-464,005 and Inhaler following 1-year (52 week) administration to Type 1 and Type 2 diabetes patients (non-smokers)
Study of Antithymocyte Globulin for Treatment of New-onset T1DM
New-onset Type 1 Diabetes MellitusAntithymocyte globulin (e.g., Thymoglobulin®) is an antibody preparation that is commonly used to treat and prevent organ transplant rejection. The START trial aims to determine whether antithymocyte globulin (ATG) treatment can halt the progression of newly diagnosed type 1 diabetes when given within 12 weeks of disease diagnosis.
Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and...
Type 1 DiabetesTo determine whether using a long-acting insulin analog at the time of diagnosis, instead of intermediate-acting insulin, affects the rate of loss of the body's ability to make insulin in children with newly diagnosed type 1 diabetes.
A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes...
Type 1 Diabetes MellitusThe purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.
B-Lymphocyte Immunotherapy in Islet Transplantation
Type 1 Diabetes MellitusType 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with the immunosuppressive medications and medications to support islet survival for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
A Research Trial of Aralast in New Onset Diabetes (RETAIN)
Diabetes MellitusType 1The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to injuries) that affects the cells thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D). All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days of Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria). The focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics (PD) and safety. Upon completion of Part I, including a satisfactory safety review, enrollment in Part II (NCT01183455, Phase II Clinical Trial) will begin.
A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
Diabetes MellitusType 1To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus
Safety and Efficacy of PEG-Encapsulated Islet Allografts Implanted in Type I Diabetic Recipients...
Diabetes MellitusType 1Insulin dependent Type I diabetics require daily insulin therapy to normalize blood glucose but may have difficulty with significant glycemic excursions and hypoglycemic episodes and crises. Islet cell transplantation can provide relief from daily insulin therapy, normalize blood glucose and reduce or eliminate short and long-term diabetes-related complications. "PEG-Encapsulated Islet Allografts" is a new islet transplant product under development that does not require the ongoing use of immunosuppressive drugs after the implant. This study will test the safety and efficacy of PEG-Encapsulated Islet Allografts in the treatment of Type I diabetes and provide functional outcome measurements.