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Trial record 59 of 1055 for:    Area Under Curve AND insulin

Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy (STAR3)

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ClinicalTrials.gov Identifier: NCT00417989
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : March 10, 2011
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Device: MiniMed Paradigm REAL-Time System
Enrollment 485
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Period Title: Overall Study
Started 244 [1] 241
Completed 224 219
Not Completed 20 22
Reason Not Completed
Withdrawal by Subject             13             13
Lost to Follow-up             1             6
Protocol Violation             1             0
Death             0             1
Physician Decision             5             2
[1]
Intent to Treat include safety population & subjects with baseline & 1 post baseline A1C measurement
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI) Total
Hide Arm/Group Description 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year Total of all reporting groups
Overall Number of Baseline Participants 244 241 485
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 241 participants 485 participants
32.2  (17.47) 31.50  (16.50) 31.90  (16.98)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 244 participants 241 participants 485 participants
<=18 years 77 72 149
Between 19 and 70 years 167 169 336
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 241 participants 485 participants
Female
104
  42.6%
107
  44.4%
211
  43.5%
Male
140
  57.4%
134
  55.6%
274
  56.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 244 participants 241 participants 485 participants
United States 216 211 427
Canada 28 30 58
1.Primary Outcome
Title Change in A1c From Baseline to 52 Weeks
Hide Description Change is defined as A1c at Week 52 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description:
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 244 241
Mean (Standard Deviation)
Unit of Measure: Percent glycated hemoglobin
-0.8  (0.84) -0.2  (0.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 722 Sensor Augmented Pump, Multiple Daily Injection (MDI)
Comments Null - There is no treatment group difference in A1c change from baseline to Week 52. Calculated that the enrollment of 495 patients would provide a power of 90% to detect an absolute difference of 0.35 percentage points in the primary outcome, assuming a SD of 1.2%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Superiority test with margin of 0.35
Statistical Test of Hypothesis P-Value 0.05
Comments Confidence Interval 95%
Method ANCOVA
Comments ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline glycated hemoglobin level (A1C)
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0.24 to 0.46
Parameter Dispersion
Type: Standard Deviation
Value: 1.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;
Hide Description Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory Blood Glucose (BG) by finger stick of less than 50 mg/dL (2.8 mmol/L). The frequency evaluates the total number of events. This will be analyzed and compared between the two study arms from baseline to week 52.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description:
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 244 241
Measure Type: Number
Unit of Measure: number of events
32 27
3.Secondary Outcome
Title Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52
Hide Description Severe Hypoglycemia is defined as a hypoglycemic episode absolutely requiring assistance from another person and preferably accompanied by a confirmatory BG by finger stick of less than 50 mg/dL (2.8 mmol/L). The rate evaluates the number of participants that experienced at least one severe hypoglycemia event and compares this number between the two study arms from Baseline to week 52. This measure identifies the rate or frequency of unique participant events.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description:
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 244 241
Measure Type: Number
Unit of Measure: participants
21 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 722 Sensor Augmented Pump, Multiple Daily Injection (MDI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.64 to 2.41
Parameter Dispersion
Type: Standard Deviation
Value: 2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;
Hide Description Hypoglycemia is defined as a recorded blood glucose event <70mg/dL. The amount of time spent below this parameter will be analyzed and compared between groups from Baseline to Week 52.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description:
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 244 241
Mean (Standard Deviation)
Unit of Measure: mmol/dl*min
0.0  (0.66) 0.0  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 722 Sensor Augmented Pump, Multiple Daily Injection (MDI)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC
5.Secondary Outcome
Title Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52
Hide Description Hyperglycemia is defined as a recorded blood glucose event > 180 mg/dL. The amount of time spent above this parameter will be analyzed and compared between groups from Baseline to Week 52.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description:
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 244 241
Mean (Standard Deviation)
Unit of Measure: mmol/dl*min
-11.9  (19.31) -1.1  (22.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 722 Sensor Augmented Pump, Multiple Daily Injection (MDI)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC
6.Secondary Outcome
Title Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score
Hide Description Difference of Baseline and 52 Weeks in Hypoglycemia Fear Scale (HFS) Overall Score between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with lower scores suggest higher satisfaction. Therefore, a negative number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Adult population (18 and older) only
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description:
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 152 151
Mean (Standard Deviation)
Unit of Measure: participants
-9.0  (16.04) -2.4  (15.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 722 Sensor Augmented Pump, Multiple Daily Injection (MDI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.5
Confidence Interval 95%
-9.760 to -3.273
Parameter Dispersion
Type: Standard Deviation
Value: 16.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Health Economic Outcome
Hide Description Health Economic Outcome was a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors. This analysis was restricted to only adult subjects (Age 19 to 70), therefore the number of participant analyzed is different. The goal was to estimate the long term cost effectiveness of Sensor Augmented Pump therapy from the perspective of the US health care system. The unit of measurement was cost in $ per year for sensor augmented pump group and MDI group. No formal statistical analysis was planned or performed
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injections (MDI)
Hide Arm/Group Description:

722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year

MiniMed Paradigm REAL-Time System: Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter

MDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 166 163
Measure Type: Number
Unit of Measure: $
10,760 5,072
8.Secondary Outcome
Title Quality of Life - Short Form-36 (SF-36v2™), General Health
Hide Description Difference of Baseline and 52 Weeks in Short Form-36 (SF-36v2™), General Health, between the two study arms (adult subjects only) is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Time Frame Baseline and 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Adult population (18 and older) only
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description:
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 153 151
Mean (Standard Deviation)
Unit of Measure: Participants
2.7  (8.07) -0.3  (7.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 722 Sensor Augmented Pump, Multiple Daily Injection (MDI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.0
Parameter Dispersion
Type: Standard Deviation
Value: 7.75
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy
Hide Description Difference of Baseline and 52 Weeks in Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction with Type of Insulin Therapy, between the two study arms is presented. Both baseline and 52 weeks scores range from 0-100, with higher scores suggest higher satisfaction. Therefore, a positive number in the difference suggests higher satisfaction at 52 Weeks than Baseline.
Time Frame Baseline and 52 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description:
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Overall Number of Participants Analyzed 220 214
Mean (Standard Deviation)
Unit of Measure: participants
18.4  (25.61) -0.2  (21.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 722 Sensor Augmented Pump, Multiple Daily Injection (MDI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.6
Parameter Dispersion
Type: Standard Deviation
Value: 25.53
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Hide Arm/Group Description 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
All-Cause Mortality
722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/244 (0.00%)      0/241 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/244 (13.11%)      30/241 (12.45%)    
Cardiac disorders     
Coronary Artery Disease  2  4/244 (1.64%)  4 1/241 (0.41%)  1
Cardiac Arrest  2  0/244 (0.00%)  0 1/241 (0.41%)  1
Supraventricular Tachycardia  2  1/244 (0.41%)  1 0/241 (0.00%)  0
Eye disorders     
Retinal Haemorrhage  1  1/244 (0.41%)  1 0/241 (0.00%)  0
Gastrointestinal disorders     
Acute Pancreatitis  2  1/244 (0.41%)  1 0/241 (0.00%)  0
General disorders     
Non-Cardiac (Atypical) Chest Pain  2  1/244 (0.41%)  1 0/241 (0.00%)  0
Infections and infestations     
Pneumonia  2  1/244 (0.41%)  1 1/241 (0.41%)  1
Gastroenteritis (Acute Gastroenteritis)  2  2/244 (0.82%)  2 2/241 (0.83%)  2
Urinary Tract Infection  2  1/244 (0.41%)  2 0/241 (0.00%)  0
Cellulitis (Cellulitis of Left Lower Leg)  2  2/244 (0.82%)  2 1/241 (0.41%)  1
Gastroenteritis  2  2/244 (0.82%)  2 2/241 (0.83%)  2
Injury, poisoning and procedural complications     
Fibula Fracture (Fracture of Left Lower Leg, Fibula at Ankle)  2  0/244 (0.00%)  0 1/241 (0.41%)  1
Skin Laceration (Traumatic Laceration to Dorsum of the Right Foot with extensor Hallucis Longus Tear  2  0/244 (0.00%)  0 1/241 (0.41%)  1
Urethral Injury (Urethral Tear)  2  0/244 (0.00%)  0 1/241 (0.41%)  1
Limb Crushing Injury (Crush Injury to Right Lateral Thigh)  2  0/244 (0.00%)  0 1/241 (0.41%)  1
Metabolism and nutrition disorders     
Hypoglycemia * 2  2/244 (0.82%)  3 0/241 (0.00%)  0
Hypoglycemia (Severe Hypoglycemia) * 2  15/244 (6.15%)  20 13/241 (5.39%)  15
Hypoglycemia  2  1/244 (0.41%)  1 0/241 (0.00%)  0
Hypoglycemia (Severe Hypoglycemia)  2  8/244 (3.28%)  10 8/241 (3.32%)  12
Diabetic Ketoacidosis (Ketoacidosis)  2  3/244 (1.23%)  3 2/241 (0.83%)  2
Dehydration  2  1/244 (0.41%)  2 0/241 (0.00%)  0
Ketoacidosis  2 [1]  0/244 (0.00%)  0 1/241 (0.41%)  1
Hypoglycemia  2 [2]  1/244 (0.41%)  1 0/241 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer (Left Breast Cancer: Invasive Ductal Adenocarcinoma)  2  0/244 (0.00%)  0 1/241 (0.41%)  1
Nervous system disorders     
Syncope Vasovagal (Syncope Vasovagal Response)  2  1/244 (0.41%)  1 0/241 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis (Kidney Stones)  2  0/244 (0.00%)  0 1/241 (0.41%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Hypertension  2  0/244 (0.00%)  0 1/241 (0.41%)  1
1
Term from vocabulary, MedDRA 8.0
2
Term from vocabulary, MedDRA (8.0)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Did not meet protocol criteria for DKA
[2]
Did not meet protocol definition of Severe Hypoglycemia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
722 Sensor Augmented Pump Multiple Daily Injection (MDI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/244 (39.34%)      49/241 (20.33%)    
General disorders     
Application site bleeding/bruising/irritation/pain  1  20/244 (8.20%)  20 4/241 (1.66%)  4
Infections and infestations     
Infusion/application site infection/abscess  1  12/244 (4.92%)  13 1/241 (0.41%)  1
Metabolism and nutrition disorders     
Hypoglycemia * 1  32/244 (13.11%)  88 28/241 (11.62%)  56
Diabetic ketoacidosis * 1  36/244 (14.75%)  51 17/241 (7.05%)  22
Hyperglycemia * 1  37/244 (15.16%)  46 7/241 (2.90%)  9
1
Term from vocabulary, MedDRA (8.0)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Scott Lee, M.D.
Organization: Medtronic
Phone: 8185764204
EMail: scott.w.lee@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00417989     History of Changes
Other Study ID Numbers: CEP179/Z25
First Submitted: January 2, 2007
First Posted: January 4, 2007
Results First Submitted: December 24, 2010
Results First Posted: March 10, 2011
Last Update Posted: May 23, 2018