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Anxiety about needles is a concern commonly expressed by diabetics when beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of longer pen needles may appeal to many diabetic patients as the shorter needle may be perceived as less intimidating and more comfortable. While pen needles of 4 to 8 mm in length are generally used for insulin injection in patients considered thin or normal weight, longer (12.7 mm) needles are still often prescribed for overweight or obese patients with diabetes. Since skin thickness is nearly constant across a range of body mass index (BMI), a clear rationale exists for the use of shorter needles in obese patients. (Gibney et al., CMRO 2010)
The primary purpose of this study is to evaluate whether the BD Ultra-Fine™ Nano 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by hemoglobin A1c levels) as the BD Ultra-Fine™ 8mm x 31G and the BD Ultra-Fine™ 12.7mm x 29G pen needles in obese subjects with diabetes.
Each subject's participation is expected to last a total of 7 months and includes a screening visit, a three-week wash-in period (one week with each of the three different size pen needles) followed by two consecutive 12 week study periods. The purpose of the three week wash-in period is to minimize the number of dropouts during the following study periods by ensuring that subjects have experience using each of the three study needles and find them generally acceptable for use during the study.
Only subjects who complete the wash-in period and confirm their agreement to continue participating will be randomized into one of the two study arms. Subjects will be randomly assigned to use the BD Ultra-Fine™ 4mm pen needle and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle. The randomization will also specify which of the two study pen needles to be used first. Half of the study subjects will use the BD Ultra-Fine™ 4mm and BD Ultra-Fine™ 8mm pen needles (4mm/8mm arm) and the other half will use the BD Ultra-Fine™ 4mm and the BD Ultra-Fine™ 12.7mm pen needles (4mm/12.7mm arm). At the end of the first 12 week study period subjects will switch to the other assigned pen needle for the second and final study period.
Glycemic control (based on HbA1c concentrations) will be assessed at baseline and at the end of each 12 week study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mm vs. 8 mm | Experimental | Subjects randomized to this study arm first used either the 4 mm x 32G Pen Needle or the 8mm x 31G Pen Needle for 12 weeks (Period 1), then switched to the alternate pen needle (PN) for another 12 weeks (Period 2). Order of PN use was randomly determined. |
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| 4 mm vs. 12.7 mm | Experimental | Subjects randomized to this study arm first used either the 4 mm x 32G Pen Needle or the 12.7mm x 29G Pen Needle (PN) for 12 weeks (Period 1), then switched to the alternate PN for another 12 weeks (Period 2). Order of PN use was randomly determined. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 mm x 32G Pen Needle | Device | During the 12 week study period, subjects use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are advised to inject straight in when using the 4mm PN, with no pinch up. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2. Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7). | Over each 12 week study period |
| Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) | Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2. Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7). | Over each 12 week study period |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | Glycemic control was assessed as by difference between the subjects' HbA1c (%) at baseline (randomization, Visit 3) and at the end of each 12 week study period,in the same manner as for the primary outcome measures. The 95% confidence interval for the mean difference in HbA1c values between the 4mm PN and the longer PN will be estimated based on general linear models adjusting for baseline HbA1c. |
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Inclusion Criteria:
Exclusion Criteria:
Administer insulin with a pump.
Currently use a syringe to inject insulin or any other diabetes-related medication.
Pregnancy.
History of intravenous drug abuse.
Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.)
Participated in any one of the following clinical studies:
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Hirsch, MD | BD Medical - Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute, Inc. | Escondido | California | 92026 | United States | ||
| Atlanta Diabetes Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20429833 | Background | Gibney MA, Arce CH, Byron KJ, Hirsch LJ. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin. 2010 Jun;26(6):1519-30. doi: 10.1185/03007995.2010.481203. | |
| 25662503 | Derived | Bergenstal RM, Strock ES, Peremislov D, Gibney MA, Parvu V, Hirsch LJ. Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes. Mayo Clin Proc. 2015 Mar;90(3):329-38. doi: 10.1016/j.mayocp.2014.12.014. Epub 2015 Feb 7. |
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Subjects who successfully completed the wash-in period and agreed to participate were further randomized into one of the study arms. Specifically, 274 of 293 subjects who were enrolled in the wash-in period completed the wash-in period and were randomized into one of the two study arms.
A total of 380 subjects were screened from the current diabetic patient population at 10 research centers in the US. Of those, 293 subjects met eligibility criteria and were enrolled in the wash-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mm First (4 vs.8) | Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2). |
| FG001 | 8 mm First (4 vs.8) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Period 1 |
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| 8mm x 31G Pen Needle | Device | During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites. |
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| 12.7mm x 29G Pen Needle | Device | During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. When using the 12.7mm PN, subjects are instructed to insert either at an angle of 45 degrees, or to pinch up and hold the pen device at a 90 degree angle (straight in). |
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| Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period. |
| Injection Pain Scores (4 mm vs. 8 mm) | At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used in Period 1. The VAS is anchored at the center (0mm) with "as painful" and at each extreme with "much less painful (-75mm) and "much more painful (+75mm); therefore a pain rating < 0 indicates that the Period 2 needle was perceived as less painful than the Period 1 needle. | At the end of Study Period 2 |
| Injection Pain Scores (4 mm vs. 12 mm) | At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with "as painful" and at each extreme with "much less painful (-75mm) and "much more painful (+75mm); therefore a negative pain rating means the period 2 needle was perceived as less painful than the period 1 needle. | At the end of Study Period 2 |
| Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle. | Subjects were asked to record hypoglycemic events in his/her diary anytime his/her blood glucose (BG) was below 50mg/dL, s/he had signs/symptoms of hypoglycemia, or s/he required medical attention for treatment. Hypoglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hypoglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject skipped a meal or exercised vigorously). | During Study Period 1 (12 weeks) and Study Period 2 (12 weeks) |
| Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle. | Subjects were asked to record hyperglycemic events in his/her diary anytime his/her blood glucose (BG) was above 400mg/dL, or s/he required medical attention for treatment for hyperglycemia. Hyperglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hyperglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject missed an insulin dose). Subjects were asked to record these events in a diary. | During Study Period 1 (12 weeks) and Study Period 2 (12 weeks) |
| Atlanta |
| Georgia |
| 30309 |
| United States |
| Springfield Diabetes and Endocrine Center | Springfield | Illinois | 62704 | United States |
| International Diabetes Center (IDC) | Minneapolis | Minnesota | 55416 | United States |
| Diabetes and Endocrine Associates | Omaha | Nebraska | 68131 | United States |
| The Molly Diabetes Center for Adults and Children at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mountain Diabetes and Endocrine Center | Asheville | North Carolina | 28803 | United States |
| University Diabetes and Endocrine Consultants | Chattanooga | Tennessee | 37403 | United States |
| Clinical Trials of Texas, Inc | San Antonio | Texas | 78229 | United States |
| Corporate Lane Internal Medicine and Research Center | Virginia Beach | Virginia | 23462 | United States |
Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
| FG002 | 4 mm First (4 vs.12.7) | Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2). |
| FG003 | 12.7 mm First ( 4 vs.12.7) | Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2). |
| COMPLETED |
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| NOT COMPLETED |
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| Study Period 2 |
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Baseline characteristics are presented for the population of subjects (274) that completed the wash-in period and were randomized into the study arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mm vs. 8 mm | Subjects randomized to this study arm first use either the 4mm PN or the 8mm PN for 12 weeks, then switched to the alternate PN for another 12 weeks. Order of PN use is randomly determined. |
| BG001 | 4 mm vs. 12.7 mm | Subjects randomized to this study arm first use either the 4mm PN or the 12.7mm PN for 12 weeks, then switch to the alternate PN for another 12 weeks. Order of PN use is randomly determined. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm) | Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2. Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7). | 115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 8 primary analysis due to protocol deviations. The total population size evaluated for the primary objective (4 vs. 8) is therefore 113. | Posted | Mean | Standard Deviation | HbA1c (%) | Over each 12 week study period |
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| Secondary | Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users | Glycemic control was assessed as by difference between the subjects' HbA1c (%) at baseline (randomization, Visit 3) and at the end of each 12 week study period,in the same manner as for the primary outcome measures. The 95% confidence interval for the mean difference in HbA1c values between the 4mm PN and the longer PN will be estimated based on general linear models adjusting for baseline HbA1c. | Of the 226 subjects who were considered for the Primary analysis, 107 subjects had at least one dose of insulin that was at least 40 units. The glycemic control of this sub-group of subjects was analyzed as in the Primary Analysis.The same analysis was performed for the high insulin dose subjects, with the two longer PN study arms pooled together. | Posted | Mean | Standard Deviation | HbA1C (%) | Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period. |
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| Secondary | Injection Pain Scores (4 mm vs. 8 mm) | At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used in Period 1. The VAS is anchored at the center (0mm) with "as painful" and at each extreme with "much less painful (-75mm) and "much more painful (+75mm); therefore a pain rating < 0 indicates that the Period 2 needle was perceived as less painful than the Period 1 needle. | 115 subjects in the 4mm vs. 8 mm study arm completed all main study visits. Two of the 115 subjects were excluded from all primary and secondary analyses due to protocol deviations. The total number of subjects analyzed for perceived pain for this study was therefore 113. | Posted | Mean | Standard Error | mm | At the end of Study Period 2 |
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| Secondary | Injection Pain Scores (4 mm vs. 12 mm) | At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with "as painful" and at each extreme with "much less painful (-75mm) and "much more painful (+75mm); therefore a negative pain rating means the period 2 needle was perceived as less painful than the period 1 needle. | 115 subjects in the 4mm vs. 12 mm study arm completed all main study visits. One of the subjects was excluded from all primary and secondary analyses due to protocol deviations. | Posted | Mean | Standard Error | mm | At the end of Study Period 2 |
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| Secondary | Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle. | Subjects were asked to record hypoglycemic events in his/her diary anytime his/her blood glucose (BG) was below 50mg/dL, s/he had signs/symptoms of hypoglycemia, or s/he required medical attention for treatment. Hypoglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hypoglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject skipped a meal or exercised vigorously). | Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hypoglycemic events. | Posted | Number | Adverse Events | During Study Period 1 (12 weeks) and Study Period 2 (12 weeks) |
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| Primary | Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm) | Subjects' glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2. Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7). | 115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 12.7 primary analysis due to protocol deviations. The total population size evaluated for this analysis is therefore 113. | Posted | Mean | Standard Deviation | HbA1c (%) | Over each 12 week study period |
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| Secondary | Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle. | Subjects were asked to record hyperglycemic events in his/her diary anytime his/her blood glucose (BG) was above 400mg/dL, or s/he required medical attention for treatment for hyperglycemia. Hyperglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hyperglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject missed an insulin dose). Subjects were asked to record these events in a diary. | Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hyperglycemic events. | Posted | Number | Adverse Events | During Study Period 1 (12 weeks) and Study Period 2 (12 weeks) |
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Adverse events that occurred during the wash-in period as well as during the two study periods were collected throughout each subject's participation in the study. Total time of participation could have been up to approximately eight months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4mm Needle | 9 | 274 | 91 | 274 | |||
| EG001 | 8mm Needle | 1 | 127 | 36 | 127 | |||
| EG002 | 12.7mm Needle | 7 | 147 | 29 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic Complications Opthalmic | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Diaphragmatic Hernias | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Gastric and Gastroenteric Infections | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal and Abdominal Pains (Excl Oral and Throat) | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| General Nutritional Disorder | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Heart Failure NEC | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hypoglycaemic Conditions NEC | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Inner Ear Signs and Symptoms | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Intestinal Ulceration and Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Ischaemic Coronary Artery Disorders | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Joint Related Signs and Symptoms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Lower Limb Fractures and Dislocations | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Lower Respiratory Tract and Lung Infections | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Lower Respiratory Tract Infection NEC | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Nausea and Vomiting Symptoms | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Non-Site Specific Injuries | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Pancreatic Neoplasms Malignant (Excl Islet Cell and Carcinoid) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
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| Prostate Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
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| Thyroid Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary Abnormalities | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemic Conditions NEC | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hyperglycaemic Conditions NEC | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Upper Respiratory Tract Infections NEC | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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The PI and Clinical Center will not publish the results pursuant to the Protocol without sponsor review and opportunity to comment on the publication or oral presentation. Abstracts and synopsis of oral presentations must be received by sponsor 30 days, and journal submissions 60 days, prior to submission. The data generated pursuant to the Protocol will be the property of the sponsor and may be used in any manner by the sponsor as it may determine in its sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laurence Hirsch, MD | Becton Dickinson | 201-847-6513 | Laurence_Hirsch@bd.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lost to Follow-up |
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| Did not continue to meet I/E Criteria |
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| Male |
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| HbA1c end of Period 2 (Visit 7) |
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