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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Interventions Drug: Insulin Detemir mixed with RAI injection
Drug: Insulin Detemir and RAI injection
Enrollment 18
Recruitment Details Eighteen participants were recruited for this trial. However, only 14 participants completed both study visits. Subjects were recruited from the clinics through fliers and online postings
Pre-assignment Details

One male subject dropped out because of a very active sports schedule and could not continue participation.

Three subjects (two males and one female) had trouble with the Continuous Glucose Monitoring (CGM) tracing and, therefore, were excluded from the final analysis.

Arm/Group Title Insulin Detemir+RAI, Then Insulin Detemir and RAI Separately Insulin Detemir and RAI Separately, Then Insulin Detemir+RAI
Hide Arm/Group 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
Period Title: First Intervention (10 Days)
Started 9 9
Received Intervention 7 7
Completed 7 7
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             1             0
Trouble with the CGM tracing             1             2
Period Title: Second Intervention (10 Days)
Started 7 7
Completed 7 7
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Participants who were randomized to receive either Insulin Detemir mixed with RAI subcutaneous injection twice daily or Insulin Detemir and RAI as separate subcutaneous injections, twice daily
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
8
  44.4%
Between 18 and 65 years
10
  55.6%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
14.8  (2.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
11
  61.1%
Male
7
  38.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
 100.0%
1.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Detemir Mixed With RAI Injection Insulin Detemir and RAI Injection Separately
Hide Arm/Group Description:
Participants who received Insulin Detemir mixed with RAI injection, twice daily as subcutaneous injection in either the first or last 10 days of the study.
Participants who received Insulin Detemir and RAI as separate subcutaneous injections, twice daily in either the first or last 10 days of the study.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: mmol*hr/L
457  (70) 469  (112)
Time Frame 10 days for each intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Detemir Mixed With RAI Injection Insulin Detemir and RAI Injection Separately
Hide Arm/Group Description Participants who received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Participants who received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days.
All-Cause Mortality
Insulin Detemir Mixed With RAI Injection Insulin Detemir and RAI Injection Separately
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Detemir Mixed With RAI Injection Insulin Detemir and RAI Injection Separately
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Insulin Detemir Mixed With RAI Injection Insulin Detemir and RAI Injection Separately
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rubina Heptulla
Organization: Children's Hospital at Montefiore
Phone: 718-920-7004
EMail: rheptull@montefiore.org
Layout table for additonal information
Responsible Party: Rubina Heptulla, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00564395     History of Changes
Other Study ID Numbers: H-16541
First Submitted: November 27, 2007
First Posted: November 28, 2007
Results First Submitted: March 2, 2018
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018