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ACCU-CHEK® Aviva Expert Study: Does Use of a Bolus Advisor Improve Glycemic Control in Patients Not Achieving Optimal Control Using Multiple Daily Injections (MDI)? (ABACUS)

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ClinicalTrials.gov Identifier: NCT01460446
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Interventions Device: Aviva Expert blood glucose meter
Device: Aviva Nano blood glucose meter
Enrollment 218
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy. Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Period Title: Overall Study
Started 105 113
Completed 100 93
Not Completed 5 20
Reason Not Completed
Non-compliance             2             9
Consent Withdrawn             0             4
Non-compliance & Consent Withdrawn             1             3
Surgery/Illness             1             1
Pregnancy             1             0
Other Reasons Incl. Lost for Follow-Up             0             3
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter Total
Hide Arm/Group Description Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy. Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy. Total of all reporting groups
Overall Number of Baseline Participants 105 113 218
Hide Baseline Analysis Population Description
Intent-to-treat population: All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 113 participants 218 participants
42.7  (13.5) 42.0  (14.5) 42.4  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 113 participants 218 participants
Female
44
  41.9%
53
  46.9%
97
  44.5%
Male
61
  58.1%
60
  53.1%
121
  55.5%
1.Primary Outcome
Title Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24
Hide Description HbA1C was measured in blood samples at a central laboratory.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 100 93
Mean (Standard Deviation)
Unit of Measure: Percentage
-0.66  (0.72) -0.47  (0.70)
2.Secondary Outcome
Title Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24
Hide Description Participants measured their blood glucose at least 3-4 times daily throughout the study. The mean blood glucose level was calculated for each 3-day period from Baseline to Week 24 and the percentage of 3-day blood glucose levels with the target range of 70-180 mg/dL (3.9-10 mmol/L) was calculated for the 2 reporting periods of Screening to Baseline and Week 23 to Week 24.
Time Frame Screening to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 100 93
Mean (Standard Deviation)
Unit of Measure: Percentage of measurements
Screening to Baseline (n=92, 86) 50.6  (14.3) 50.7  (15.1)
Week 23 to Week 24 (n=92, 86) 49.3  (17.2) 52.2  (15.5)
3.Secondary Outcome
Title Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24
Hide Description A symptomatic hypoglycemic episode was defined as an event with symptoms consistent with hypoglycemia which was confirmed by a blood glucose reading < 70 mg/dL (3.9 mmol/L). Symptoms might include but were not limited to sweating, dizziness, lightheadedness, tremors, nervousness, hunger, headaches, and weakness or tiredness.
Time Frame Screening to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 100 93
Mean (Standard Deviation)
Unit of Measure: Episodes per year
Screening to Baseline (n=100, 93) 18.9  (50.8) 23.2  (73.8)
Week 23 to Week 24 (n=93, 91) 17.0  (43.6) 15.8  (56.7)
4.Secondary Outcome
Title Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24
Hide Description Approximately half of the investigational sites monitored glucose levels in participants enrolled in this study using the DexCom Seven® Plus Continuous Glucose Monitoring device. The device provides glucose measurements every 5 minutes for up to 7 days. The system contains a sensor, transmitter, and receiver. The sensor is a flexible round wire that goes under the skin to read glucose levels. The transmitter snaps into the sensor and wirelessly sends glucose readings to the receiver. Data was obtained from approximately one-third of participants and was used to calculate MAGE. Data were collected in the 3 days prior to Baseline and the Week 24 visit. The standard deviation of the blood glucose measurements in each 3-day period was calculated. For each glucose measurement, the difference from the previous reading was calculated. Absolute differences smaller than the standard deviation were discarded. MAGE is the mean of the remaining difference scores.
Time Frame 3 days prior to Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants with continuous glucose monitoring data at Baseline and at Week 24 who completed the study.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: mg/dL
-20.2  (41.1) -2.9  (32.1)
5.Secondary Outcome
Title Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study
Hide Description Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants.
Arm/Group Title Aviva Expert Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: Percentage of opportunities
73.5  (21.9)
6.Secondary Outcome
Title Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study
Hide Description Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants.
Arm/Group Title Aviva Expert Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: Number of advices modified per day
0.3  (0.5)
7.Secondary Outcome
Title Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study
Hide Description Participants using the Aviva Nano blood glucose meter received individualized advice in how to use their insulin:carbohydrate ratio (I:CHO) and insulin sensitivity factor (ISF) values to determine their insulin dose. The I:CHO ratio advice was considered to have been used correctly if the meal bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant's total carbohydrate intake and the I:CHO ratio. The ISF advice was considered to have been correctly used if the correction bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant's blood glucose target, current blood glucose value, and the ISF.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study. Results are only reported for participants using the Aviva Nano blood glucose meter who had data available for analysis.
Arm/Group Title Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: Number of advices per day
I:CHO - correct (n=88) 1.55  (1.1)
I:CHO - incorrect (n=88) 1.77  (0.9)
ISF - correct (n=78) 0.81  (0.7)
ISF - incorrect (n=78) 2.14  (0.9)
8.Secondary Outcome
Title Change in Carbohydrate Counting Accuracy From Baseline to Week 24
Hide Description Participants were asked to assess the carbohydrate content (grams) of 10 standardized meals by using a set of Dose Adjustment for Normal Eating (DAFNE) plates, which provide standardized photographs of meals with known carbohydrate values. The mean meal error (MME), an indicator of accuracy, and mean meal absolute error (MMAE), an indicator of variability were calculated from their responses. The MME is defined as the mean of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. A negative MME indicates an underestimation and a positive MME indicates an overestimation of the actual carbohydrate content. The MMAE is defined as the mean of the absolute value of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. The MMAE is ≥ 0 with a lower value indicating a better ability to estimate the actual carbohydrate content.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 99 92
Mean (Standard Deviation)
Unit of Measure: Grams
Mean Meal Error -0.90  (10.0) 0.07  (11.2)
Mean Meal Absolute Error -2.9  (8.2) 0.9  (9.4)
9.Secondary Outcome
Title Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24
Hide Description The Patient Health Questionnaire depression scale (PHQ-8) contains 8 items which can be rated from 0='not at all' to 3='nearly every day'. The total PHQ-8 score is the sum of the responses to the 8 items and ranges from 0 to 24. A lower score indicates less depression. A negative change score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who had data available for analysis.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 95 89
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.36  (3.21) -0.08  (3.87)
10.Secondary Outcome
Title Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24
Hide Description The Major Depression Disorder (MDD) scale is derived from the Patient Health Questionnaire depression scale (PHQ-8) and was used to categorize participants in regard to the severity of their depression. There are 5 categories on the MDD scale: None, mild, moderate, moderately severe, and severe. The category for each participant is determined from their PHQ-8 score. A total PHQ-8 score of 0 to 4 represents no significant depressive symptoms. A total PHQ-8 score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. A higher score indicates more depression.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 100 93
Measure Type: Number
Unit of Measure: Participants
Baseline - None (n=100, 93) 66 55
Baseline - Mild (n=100, 93) 22 26
Baseline - Moderate (n=100, 93) 11 9
Baseline - Moderately Severe (n=100, 93) 1 2
Baseline - Severe (n=100, 93) 0 1
Week 24 - None (n=95, 89) 67 54
Week 24 - Mild (n=95, 89) 21 23
Week 24 - Moderate (n=95, 89) 7 10
Week 24 - Moderately Severe (n=95, 89) 0 2
Week 24 - Severe (n=95, 89) 0 0
11.Secondary Outcome
Title Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24
Hide Description The Problem Area in Diabetes (PAID) scale contains 20 items which can be rated from 0='not a problem' to 4='serious problem'. The total PAID scale score ranges from 0 to 80 with a higher score indicating more diabetes-related problems. A negative change score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 97 91
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.4  (11.2) -4.4  (8.6)
12.Secondary Outcome
Title Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24
Hide Description The Hypoglycemia Fear Survey-II (HFS-II) contains 33 items (15 items regarding behavior and 18 items regarding worry) which can be rated from 0='never' to 4='always'). The total HFS-II score ranges from 0 to 132 with a higher score indicating more fear. A negative change score indicates improvement.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 97 91
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.7  (13.3) -5.9  (11.9)
13.Secondary Outcome
Title The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score
Hide Description

The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) contains 6 items which can be scored from 0='very bad' to 6='very good'. The total score is the sum of the scores of the 6 items and ranges from 0 to 36. A higher score indicates more satisfaction. This questionnaire was administered at Baseline only.

The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3='much worse now' to 3='much better now'). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized participants who completed the study.
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description:
Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
Overall Number of Participants Analyzed 100 93
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=99, 93) 27.9  (6.2) 28.1  (5.7)
Week 24 (n=98, 92) 11.4  (6.0) 8.9  (6.3)
Time Frame [Not Specified]
Adverse Event Reporting Description Intent-to-treat population: All randomized participants.
 
Arm/Group Title Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Hide Arm/Group Description Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy. Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
All-Cause Mortality
Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Affected / at Risk (%) Affected / at Risk (%)
Total   8/105 (7.62%)   10/113 (8.85%) 
Cardiac disorders     
Angina pectoris † 1  1/105 (0.95%)  0/113 (0.00%) 
Coronary artery disease † 1  0/105 (0.00%)  1/113 (0.88%) 
Left ventricular dysfunction † 1  1/105 (0.95%)  0/113 (0.00%) 
Eye disorders     
Retinal haemorrhage † 1  1/105 (0.95%)  0/113 (0.00%) 
Gastrointestinal disorders     
Change of bowel habit † 1  1/105 (0.95%)  0/113 (0.00%) 
Infections and infestations     
Lower respiratory tract infection † 1  1/105 (0.95%)  0/113 (0.00%) 
Pyelonephritis † 1  0/105 (0.00%)  1/113 (0.88%) 
Urinary tract infection viral † 1  0/105 (0.00%)  1/113 (0.88%) 
Injury, poisoning and procedural complications     
Ankle fracture † 1  1/105 (0.95%)  0/113 (0.00%) 
Tracheal injury † 1  1/105 (0.95%)  0/113 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia † 1  1/105 (0.95%)  3/113 (2.65%) 
Hyperglycaemia † 1  0/105 (0.00%)  1/113 (0.88%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain † 1  0/105 (0.00%)  1/113 (0.88%) 
Pain in extremity † 1  1/105 (0.95%)  0/113 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hypopharyngeal cancer † 1  0/105 (0.00%)  1/113 (0.88%) 
Nervous system disorders     
Dizziness † 1  0/105 (0.00%)  1/113 (0.88%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia † 1  0/105 (0.00%)  1/113 (0.88%) 
Skin and subcutaneous tissue disorders     
Skin ulcer † 1  1/105 (0.95%)  0/113 (0.00%) 
Vascular disorders     
Peripheral vascular disorder † 1  1/105 (0.95%)  0/113 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aviva Expert Blood Glucose Meter Aviva Nano Blood Glucose Meter
Affected / at Risk (%) Affected / at Risk (%)
Total   49/105 (46.67%)   56/113 (49.56%) 
Gastrointestinal disorders     
Diarrhoea † 1  2/105 (1.90%)  6/113 (5.31%) 
Infections and infestations     
Nasopharyngitis † 1  15/105 (14.29%)  30/113 (26.55%) 
Metabolism and nutrition disorders     
Hypoglycaemia † 1  44/105 (41.90%)  34/113 (30.09%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[Not Specified]
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01460446    
Other Study ID Numbers: RD001333
First Submitted: September 22, 2011
First Posted: October 26, 2011
Results First Submitted: November 14, 2013
Results First Posted: February 6, 2014
Last Update Posted: February 6, 2014