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Trial record 5 of 1061 for:    Area Under Curve AND insulin

Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH

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ClinicalTrials.gov Identifier: NCT00564018
Recruitment Status : Terminated (Presumed loss of clinical equipoise between the agents being investigated)
First Posted : November 27, 2007
Results First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: Insulin detemir
Drug: Glargine
Drug: NPH
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Detemir NPH Insulin Glargine
Hide Arm/Group Description Subjects randomized to treatment with insulins detemir and aspart Subjects randomized to treatment with insulins NPH and aspart Subjects randomized to treatment with insulins glargine and aspart
Period Title: Overall Study
Started 11 10 12
Completed 9 7 11
Not Completed 2 3 1
Reason Not Completed
Withdrawal by Subject             2             3             1
Arm/Group Title Detemir Isophane (NPH) Insulin Glargine Total
Hide Arm/Group Description Subjects randomized to treatment with insulins detemir and aspart Subjects randomized to treatment with insulins NPH and aspart Subjects randomized to treatment with insulins glargine and aspart Total of all reporting groups
Overall Number of Baseline Participants 11 10 12 33
Hide Baseline Analysis Population Description
Subjects who completed randomization into one of the three treatment arms
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 8 participants 11 participants 29 participants
10.1  (3.0) 11.0  (1.6) 9.9  (2.5) 10.3  (3.0)
[1]
Measure Analysis Population Description: Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 12 participants 33 participants
Female
4
  36.4%
6
  60.0%
9
  75.0%
19
  57.6%
Male
7
  63.6%
4
  40.0%
3
  25.0%
14
  42.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 12 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   9.1%
0
   0.0%
0
   0.0%
1
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   9.1%
3
  30.0%
2
  16.7%
6
  18.2%
White
9
  81.8%
7
  70.0%
10
  83.3%
26
  78.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 12 participants 33 participants
11 10 12 33
Hemoglobin A1c (percent)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 10 participants 8 participants 11 participants 29 participants
11.9  (1.7) 12.6  (1.7) 12.1  (1.8) 12.2  (1.7)
[1]
Measure Analysis Population Description: Subjects were enrolled immediately after diagnosis of diabetes. Subjects who then were antibody (-) for type 1 diabetes associated antibodies are excluded from the baseline data reported.
Bicarbonate (HCO3) (meq/L)   [1] 
Mean (Standard Deviation)
Unit of measure:  meQ/L
Number Analyzed 10 participants 8 participants 11 participants 29 participants
21.0  (4.7) 15.6  (6.1) 14.9  (8.1) 17.3  (6.8)
[1]
Measure Analysis Population Description: Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.
Beta Hydroxy Butyrate (mmol/L)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 10 participants 8 participants 11 participants 29 participants
4.7  (2.6) 3.9  (3.5) 7.9  (4.0) 5.5  (3.6)
[1]
Measure Analysis Population Description: Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.
Total Daily Dose of Insulin (Units/kg/day)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units/kg/day
Number Analyzed 10 participants 8 participants 11 participants 29 participants
0.70  (0.11) 0.69  (0.12) 0.75  (0.14) 0.70  (0.10)
[1]
Measure Analysis Population Description: Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.
1.Primary Outcome
Title C-peptide Area Under the Curve
Hide Description We measured the insulin secretory capacity of the pancreas by measuring C-peptide levels (and calculating the C-peptide area under the curve (AUC) using the trapezoidal method following a mixed meal tolerance test (using Boost) at 1, 6 and 12 months after diagnosis.
Time Frame Although measured at 1, 6 and 12 months, the primary outcomes was a comparison between treatment groups at 6 months after diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed 6 month mixed meal tolerance test (MMTT)s
Arm/Group Title Detemir NPH Insulin Glargine
Hide Arm/Group Description:
Subjects randomized to treatment with insulins detemir and aspart
Subjects randomized to treatment with insulins NPH and aspart
Subjects randomized to treatment with insulins glargine and aspart
Overall Number of Participants Analyzed 10 7 10
Median (Inter-Quartile Range)
Unit of Measure: ng*hr/mL
220
(143 to 312)
144
(83 to 302)
51
(29 to 123)
2.Secondary Outcome
Title Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis
Hide Description We assessed glycemic control via measurement of Hemoglobin A1c at each quarterly clinic visit after diagnosis of diabetes. Data on the 6 month time point are presented
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data is presented for each subject at each time for which there was a measure.
Arm/Group Title Detemir NPH Insulin Glargine
Hide Arm/Group Description:
Subjects randomized to treatment with insulins detemir and aspart
Subjects randomized to treatment with insulins NPH and aspart
Subjects randomized to treatment with insulins glargine and aspart
Overall Number of Participants Analyzed 10 8 11
Mean (Standard Deviation)
Unit of Measure: percent
7.6  (1.3) 8.0  (2.0) 7.9  (1.2)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Detemir NPH Insulin Glargine
Hide Arm/Group Description Subjects randomized to treatment with insulins detemir and aspart Subjects randomized to treatment with insulins NPH and aspart Subjects randomized to treatment with insulins glargine and aspart
All-Cause Mortality
Detemir NPH Insulin Glargine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Detemir NPH Insulin Glargine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Detemir NPH Insulin Glargine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%)   0/12 (0.00%) 
Interpretation of the data is limited by the small sample sizes due to early study termination
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Soumya Adhikari, MD
Organization: UT Southwestern Medical Center
Phone: 214 456 5959
EMail: soumya.adhikari@utsouthwestern.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00564018     History of Changes
Other Study ID Numbers: UTSW-052006-056
816 ( Other Identifier: UT Southwestern Medical Center GCRC ID )
First Submitted: November 26, 2007
First Posted: November 27, 2007
Results First Submitted: March 21, 2019
Results First Posted: October 11, 2019
Last Update Posted: October 11, 2019