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Completed

NCT Number: NCT00564395

Detemir: Role in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Texas Children's Hospital Endocrine and Diabetes Clinic

Houston, Texas, 77030, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Detemir mixed with RAI injection

Drug

Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection

Insulin Detemir and RAI injection

Drug

Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Nov 28, 2007
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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