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

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ClinicalTrials.gov Identifier: NCT00564018
Recruitment Status : Terminated (Presumed loss of clinical equipoise between the agents being investigated)
First Posted : November 27, 2007
Last Update Posted : June 14, 2012
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Insulin detemir Drug: Glargine Drug: NPH Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH
Study Start Date : September 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. C-peptide area under the curve in response to a mixed meal tolerance test 6 months after diagnosis of diabetes. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Glycemic control as determined by HgbA1c values at quarterly intervals after diagnosis of diabetes. [ Time Frame: Quarterly for 12 months. ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: November 2007

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
Insulin
Insulin Glargine
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs