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

November 26, 2007
June 12, 2012
September 2006
February 2009   (final data collection date for primary outcome measure)
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 ]
C-peptide area under the curve in response to a mixed meal tolerance test 6 months after diagnosis of diabetes. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00564018 on ClinicalTrials.gov Archive Site
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 ]
Glycemic control as determined by HgbA1c values at quarterly intervals after diagnosis of diabetes. [ Time Frame: Quarterly for 12 months. ]
Not Provided
Not Provided
 
Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH
Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
  • Drug: Insulin detemir
    Dosage adjusted to meet age-specific glycemic goals throughout course of study.
    Other Name: Levemir
  • Drug: Glargine
    Dosage to be adjusted to meet age-specific glycemic goals throughout course of study.
    Other Name: Lantus
  • Drug: NPH
    Dosage to be adjusted to meet age specific glycemic goals throughout course of study.
  • Experimental: Detemir
    24 subjects randomized to therapy with a combination of insulins detemir and aspart at diagnosis of diabetes.
    Intervention: Drug: Insulin detemir
  • Experimental: Glargine
    24 subjects randomized to therapy with a combination of insulins glargine and aspart at diagnosis of diabetes.
    Intervention: Drug: Glargine
  • Experimental: NPH
    24 subjects randomized to therapy with a combination of insulins NPH and aspart at diagnosis of diabetes.
    Intervention: Drug: NPH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
April 2011
February 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00564018
UTSW-052006-056, GCRC Protocol #816
No
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Novo Nordisk A/S
Principal Investigator: Soumya Adhikari, MD University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP