Detemir: Role in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT00564395|
Recruitment Status : Completed
First Posted : November 28, 2007
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Insulin Detemir mixed with RAI injection Drug: Insulin Detemir and RAI injection||Phase 4|
One of the barriers to good glycemic control in children with type 1 diabetes is multiple daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in the same syringe would decrease the number of injections and may improve adherence
This study hypothesized that slow-acting insulin detemir mixed with aspart would have equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes.
Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited. However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose values over time were calculated as area under the curve (AUC), index of blood glucose control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||May 2010|
Experimental: Insulin Detemir+RAI, then Insulin Detemir and RAI separately
Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days.
Drug: Insulin Detemir mixed with RAI injection
Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection
Active Comparator: Insulin Detemir and RAI separately, then Insulin Detemir+RAI
Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days.
Drug: Insulin Detemir and RAI injection
Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection
- Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections [ Time Frame: 0-48 hours post-dose ]Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections.
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): NCT00564395
|United States, Texas|
|Texas Children's Hospital Endocrine and Diabetes Clinic|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rubina A Heptulla, MD||Baylor College of Medicine|