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:
University of Texas Southwestern Medical Center
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
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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
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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
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, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases |
Metabolic Diseases Glargine Insulin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 03, 2015