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Trial record 34 of 1011 for:    Area Under Curve AND insulin

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
Sponsor:
Information provided by (Responsible Party):
Rubina Heptulla, Montefiore Medical Center

Brief Summary:
Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.

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

Detailed Description:

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)
  • On insulin glargine for at least 3 months
  • Age 10-25 years
  • Not on medications that may affect glucose concentrations
  • Hemoglobin A1C (HbA1C) of less than 9 %
  • Body Mass Index (BMI) less than 95th % and more than 10th%
  • Supportive family

Exclusion Criteria:

  • Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)
  • Unable to adhere to insulin regimen
  • Positive urine pregnancy test

Information from the National Library of Medicine

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


Locations
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United States, Texas
Texas Children's Hospital Endocrine and Diabetes Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Rubina A Heptulla, MD Baylor College of Medicine

Publications:
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Responsible Party: Rubina Heptulla, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00564395     History of Changes
Other Study ID Numbers: H-16541
First Posted: November 28, 2007    Key Record Dates
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018
Last Verified: July 2018

Keywords provided by Rubina Heptulla, Montefiore Medical Center:
blood sugar
glycemic

Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Detemir
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs