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Trial record 5 of 1056 for:    Area Under Curve AND insulin

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
Results First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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

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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

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.
Other Name: Neutral Protamine Hagedorn




Primary Outcome Measures :
  1. C-peptide Area Under the Curve [ Time Frame: Although measured at 1, 6 and 12 months, the primary outcomes was a comparison between treatment groups at 6 months after diagnosis ]
    We measured the insulin secretory capacity of the pancreas by measuring C-peptide levels (and calculating the C-peptide area under the curve (AUC) using the trapezoidal method following a mixed meal tolerance test (using Boost) at 1, 6 and 12 months after diagnosis.


Secondary Outcome Measures :
  1. Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis [ Time Frame: 6 months ]
    We assessed glycemic control via measurement of Hemoglobin A1c at each quarterly clinic visit after diagnosis of diabetes. Data on the 6 month time point are presented



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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

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
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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
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Principal Investigator: Soumya Adhikari, MD University of Texas Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00564018     History of Changes
Other Study ID Numbers: UTSW-052006-056
816 ( Other Identifier: UT Southwestern Medical Center GCRC ID )
First Posted: November 27, 2007    Key Record Dates
Results First Posted: October 11, 2019
Last Update Posted: October 11, 2019
Last Verified: October 2019
Keywords provided by University of Texas Southwestern Medical Center:
type 1 diabetes, basal-bolus, honeymoon, C-peptide
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Detemir
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs