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

This study has been terminated.
(Presumed loss of clinical equipoise between the agents being investigated)
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00564018
First received: November 26, 2007
Last updated: June 12, 2012
Last verified: November 2007
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Drug: Insulin detemir
Drug: Glargine
Drug: NPH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • C-peptide area under the curve in response to a mixed meal tolerance test 6 months after diagnosis of diabetes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic control as determined by HgbA1c values at quarterly intervals after diagnosis of diabetes. [ Time Frame: Quarterly for 12 months. ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2006
Study Completion Date: April 2011
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Detemir
24 subjects randomized to therapy with a combination of insulins detemir and aspart at diagnosis of diabetes.
Drug: Insulin detemir
Dosage adjusted to meet age-specific glycemic goals throughout course of study.
Other Name: Levemir
Experimental: Glargine
24 subjects randomized to therapy with a combination of insulins glargine and aspart at diagnosis of diabetes.
Drug: Glargine
Dosage to be adjusted to meet age-specific glycemic goals throughout course of study.
Other Name: Lantus
Experimental: NPH
24 subjects randomized to therapy with a combination of insulins NPH and aspart at diagnosis of diabetes.
Drug: NPH
Dosage to be adjusted to meet age specific glycemic goals throughout course of study.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564018

Locations
United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Novo Nordisk A/S
Investigators
Principal Investigator: Soumya Adhikari, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00564018     History of Changes
Other Study ID Numbers: UTSW-052006-056, GCRC Protocol #816
Study First Received: November 26, 2007
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
type 1 diabetes, basal-bolus, honeymoon, C-peptide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014