Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin Glargine; Insulin, Globin Zinc; Protamines

Criteria

Inclusion Criteria:

• Newly diagnosed type 1 diabetes within 1 week of diagnosis

• Age 6 - 18 years

• Care provided at Children's Medical Center, Dallas

Exclusion Criteria:

• Actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycemic agents)

• Actual treatment with drugs influencing insulin sensitivity (e.g. Metformin, or systemic steroids)

• Significant concomitant disease likely to interfere with glucose metabolism (children with active bacterial infections at the time of diagnosis must be cured prior to entry)

• Expected poor compliance

• Pregnancy

• Any other condition that by the judgement of the investigator may be potentially harmful to the patients