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Detemir: Role in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Insulin Detemir mixed with RAI injection
Insulin Detemir and RAI injection
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring blood sugar, glycemic

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Children's Hospital Endocrine and Diabetes Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Detemir+RAI, then Insulin Detemir and RAI separately

Insulin Detemir and RAI separately, then Insulin Detemir+RAI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2007
Last Updated
July 13, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00564395
Brief Title
Detemir: Role in Type 1 Diabetes
Official Title
Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
blood sugar, glycemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Detemir+RAI, then Insulin Detemir and RAI separately
Arm Type
Experimental
Arm Description
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.
Arm Title
Insulin Detemir and RAI separately, then Insulin Detemir+RAI
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin Detemir mixed with RAI injection
Intervention Description
Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Insulin Detemir and RAI injection
Intervention Description
Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
0-48 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubina A Heptulla, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital Endocrine and Diabetes Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20504899
Citation
Nguyen TM, Renukuntla VS, Heptulla RA. Mixing insulin aspart with detemir does not affect glucose excursion in children with type 1 diabetes. Diabetes Care. 2010 Aug;33(8):1750-2. doi: 10.2337/dc10-0169. Epub 2010 May 26.
Results Reference
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Detemir: Role in Type 1 Diabetes

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