NCT00564395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

July 17, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

2.3 years

First QC Date

November 27, 2007

Results QC Date

March 2, 2018

Last Update Submit

July 13, 2018

Conditions

Type 1 Diabetes Mellitus

Keywords

blood sugarglycemic

Outcome Measures

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

    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

Study Arms (2)

Insulin Detemir+RAI, then Insulin Detemir and RAI separately

EXPERIMENTAL

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 and RAI separately, then Insulin Detemir+RAI

ACTIVE COMPARATOR

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

Interventions

Insulin Detemir mixed with RAI injectionDRUG

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

Insulin Detemir+RAI, then Insulin Detemir and RAI separately
Insulin Detemir and RAI injectionDRUG

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

Insulin Detemir and RAI separately, then Insulin Detemir+RAI

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital Endocrine and Diabetes Clinic

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 20504899BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Dr. Rubina Heptulla
Organization
Children's Hospital at Montefiore
rheptull@montefiore.org
718-920-7004

Study Officials

  • Rubina A Heptulla, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

July 17, 2018

Results First Posted

July 17, 2018

Record last verified: 2018-07

Locations

US(1)