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

History of Changes

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: Insulin Insulin human Insulin glargine Insulin detemir

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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


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 (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

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


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

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

ClinicalTrials.gov processed this record on September 18, 2017

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