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

Arm | Intervention/treatment |
---|---|
Experimental: Detemir
24 subjects randomized to therapy with a combination of insulins detemir and aspart at diagnosis of diabetes.
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Drug: Insulin detemir
Dosage adjusted to meet age-specific glycemic goals throughout course of study.
Other Name: Levemir
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Experimental: Glargine
24 subjects randomized to therapy with a combination of insulins glargine and aspart at diagnosis of diabetes.
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Drug: Glargine
Dosage to be adjusted to meet age-specific glycemic goals throughout course of study.
Other Name: Lantus
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Experimental: NPH
24 subjects randomized to therapy with a combination of insulins NPH and aspart at diagnosis of diabetes.
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Drug: NPH
Dosage to be adjusted to meet age specific glycemic goals throughout course of study.
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- C-peptide area under the curve in response to a mixed meal tolerance test 6 months after diagnosis of diabetes. [ Time Frame: 6 months ]
- Glycemic control as determined by HgbA1c values at quarterly intervals after diagnosis of diabetes. [ Time Frame: Quarterly for 12 months. ]

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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Texas | |
Children's Medical Center | |
Dallas, Texas, United States, 75235 |
Principal Investigator: | Soumya Adhikari, MD | University of Texas Southwestern Medical Center |
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 |