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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
24 subjects randomized to therapy with a combination of insulins glargine and aspart at diagnosis of diabetes.
Dosage to be adjusted to meet age-specific glycemic goals throughout course of study.
Other Name: Lantus
24 subjects randomized to therapy with a combination of insulins NPH and aspart at diagnosis of diabetes.
Dosage to be adjusted to meet age specific glycemic goals throughout course of study.
Other Name: Neutral Protamine Hagedorn
- 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.
- 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
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|