Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus

Stony Brook University

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: pioglitazone; Drug: Placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT00545857

20064114

Details and patient eligibility

About

A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.

Full description

Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.

Enrollment: 15 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 1 diabetes mellitus diagnosed within 4 months
• Age > 6 years of age
• Ability to swallow capsule
• Signed informed consent / assent

Exclusion criteria

• Other illnesses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Pioglitazone

Experimental group

Treatment:

Drug: Placebo control

Drug: pioglitazone

Placebo control

Placebo Comparator group

Treatment:

Drug: Placebo control

Drug: pioglitazone