Type 1 Diabetes Mellitus

Gluten Free Diet

Placebo No intervention, standard T1DM diet

Placebo

Effects of Gluten Free Diet on Type 1 Diabetes Mellitus in Children

Effect of a Gluten Free Diet on Ameliorating New Onset Type 1 Diabetes Mellitus in Children and Adolescents

Loma Linda University

This study was terminated prior to full subject accrual because of changes to study personnel. The original study design was changed from a double-blind, placebo-controlled study to an open-label pilot study in order to collect safety data on enrolled subjects prior to study termination.

Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.

T1D Group

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Change in C-peptide

Glycemia Control (Change in HbA1c Level)

Change in Insulin Dose

Change in Anti-GAD Autoantibody Titers

Change in Anti-IA2 Titer

Change in ZnT8 Autoantibody Titer

Overall Study

Dr. Rana Malek

Diabetes Mellitus Type 1

Autoimmune Diabetes

Insulin

Lansoprazole

Sitagliptin

Diamyd

GAD65 (Diamyd)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

Novel Therapy Combining Regenerative Stimuli Immunomodulation to Preserve Beta Cell Function in New Onset Type 1 Diabetes

James Balow

Clinical Director Intramural NIDDK

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recombinant human intranasal insulin formulation in a buffered solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product is formulated at a dose strength of 1100 IU / mL (40mg/mL) manufacturing formulation. The product will be self administered by eligible participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.

Placebo insulin carrier solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product will be self administered by participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.

Type 1 Diabetes

Intranasal insulin

Placebo insulin carrier solution containing benzalkonium chloride and glycerol

The Children's Hospital at Westmead

Mater Children's Hospital

Womens and Childrens Hospital

Royal Melbourne Hospital

Princess Margaret Hospital

University of Auckland

Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes

A Randomised, Double-blind, Placebo-controlled Trial of Intranasal Insulin (440 IU) in Children and Young Adults at Risk of Type 1 Diabetes: Intranasal Insulin Trial II

Defined as the presence of 2 or more of the following diagnostic criteria including diabetic fasting blood glucose level, diabetic 2 hour postprandial blood glucose level, diabetic HbA1c and symptoms

Measured as glucose and insulin responses in Oral glucose tolerance test (OGTT) 6 monthly

Insulin resistance measured by Homeostasis of model assessment - resistance (HOMA-R) 6 monthly

Measured by levels of circulating antibodies to insulin, Glutamic acid decarboxylase (GAD) and Tyrosine phosphatase - like insulinoma antigen (IA-2) and T cell responses to proinsulin, denatured insulin, GAD and tetanus at 5 years

Melbourne Health

Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved.

Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control.

Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).

Rosiglitazone Autoantibody Positive

Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).

Rosiglitazone Autoantibody Negative

Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).

Glyburide Autoantibody Positive

Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).

Glyburide Autoantibody Negative

Total

Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.

Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.

Number of participants positive for T cell reactivity to islet proteins at 36 months.

Patients Positive for T Cell Responses to Islet Proteins at 36 Months.

Jerry P. Palmer, MD

Type 2 Diabetes Mellitus

Tablet taken orally at a dosage of 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Study drug was taken up to 3 years.

rosiglitazone

Tablet taken orally, initially 2.5 mg in the morning or dose subject received prior to starting the study. Dosage was increased by 2.5 mg in the evening up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Study drug was taken up to 3 years.

glutamic acid decarboxylase/obesity

Effects of Gluten Free Diet on Type 1 Diabetes Mellitus in Children

Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes

Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes

Preferred Treatment of Type 1.5 Diabetes

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