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
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
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014