Detemir: Role in Type 1 Diabetes

July 13, 2018 updated by: Rubina Heptulla, Montefiore Medical Center

Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital Endocrine and Diabetes Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-48 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: RUBINA A HEPTULLA, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (Estimate)

November 28, 2007

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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