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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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Several studies have shown that high blood sugar (glucose) levels are associated with diseases caused by diabetes. Controlling the glucose may prevent these complications. As people age, their bodies become unable to make enough insulin to control the blood sugars. Pills used to treat diabetes may help for a while, but many times this does not last. When the blood sugar is too high, insulin is frequently recommended and used to treat diabetes. Insulin is often started by adding a long-acting insulin to the medicines a patient already takes. In this study, glargine insulin will be taken together with the diabetes pills currently being used. Glargine is a long-acting insulin which is given under the skin once a day. Glargine is approved for use in the treatment of patients with diabetes by the FDA (Food and Drug Administration).
Currently, insulin delivery is only available as a shot. The purpose of this study is to compare how satisfied patients are when using two different types of insulin shots. Specifically, this study aims to determine if people over 65 years old are more satisfied taking insulin shots by pens or syringes. Everyone who joins in this study will have a chance to use the insulin syringes and the insulin pens.
The ability of patients to give themselves shots can affect how well the sugar is controlled. As people age, medical and other problems may develop that affect their ability to do certain things. Another aim of this study is to determine if the ability to use an insulin pen and insulin syringe is affected by age or some other problem.
During this study, participants will be treated with insulin given by a syringe for 12 weeks and by a pen for 12 weeks. Questionnaires will be given to determine satisfaction with treatment throughout the study. The investigators hypothesize that among elderly patients with type 2 diabetes mellitus failing oral agent therapy, treatment with basal insulin via a pen device results in higher treatment satisfaction scores and more accurate dosing than treatment with basal insulin via conventional vial and syringe methods.
A total of 56 subjects with type 2 diabetes will be recruited into this study. The site for the study is Grady Memorial Hospital clinics in Atlanta, Georgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vial & Syringe (Period 1) / Pen (Period 2) | Active Comparator | Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2. |
|
| Pen (Period 1) / Vial & Syringe (Period 2) | Experimental | Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glargine | Drug | oral antidiabetic agents plus once daily insulin glargine via an insulin syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score | Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained from summing responses to questions 1, 4, 5, 6, 7, and 8 and the total score can range from 0 to 36. Higher scores indicate higher satisfaction with diabetes treatment. | Baseline, Week 12 |
| Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score | Treatment satisfaction after crossover into the second treatment period was assessed using the Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc). The questionnaire contains eight items scored on a seven-point scale where -3 = much less satisfied now and 3 = much more satisfied now. The satisfaction score is obtained from summing responses to questions 1, and 4 through 8 (the remaining two items assess perceived blood sugar levels). The total score can range from -18 to 18. Higher scores indicate higher satisfaction with the new diabetes treatment, compared to prior treatment, while scores below 0 mean that satisfaction with the new delivery method of insulin in Period 2 is lower than satisfaction with the delivery method in Period 1. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | Hemoglobin A1c (HbA1c) measures the average percentage of blood sugar over the past 2 to 3 months. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. HbA1c can reduce with management of diabetes through diet, exercise, and medication. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoper Newton, MD | Emory University SOM | Principal Investigator |
| Dawn Smiley, MD, MSCR | Emory University SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
Of the 56 individuals who consented to take part in the study, 7 were removed prior to being randomized to a group (2 did not meet eligibility criteria and 5 withdrew consent prior to group assignment). Those who were not randomized were not considered to be enrolled in the study as group assignment was never determined.
Enrollment of subjects started in January 2011 and all study participation was completed in December 2012. Patients were recruited from the Grady Memorial Hospital Diabetes Clinic in Atlanta, Georgia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vial & Syringe (Period 1) / Pen (Period 2) | Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2. |
| FG001 | Pen (Period 1) / Vial & Syringe (Period 2) | Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 12-week Crossover Phase - Period 1 |
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| ||||||||||||||||||
| 12-week Crossover Phase - Period 2 |
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The baseline analysis includes the 46 participants who completed the trial (23 in Vial & Syringe to Pen group and 23 in Pen to Vial & Syringe group).
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| ID | Title | Description |
|---|---|---|
| BG000 | Vial & Syringe (Period 1) / Pen (Period 2) | Crossover study group where participants were randomized to the sequence of insulin glargine via vial and syringe in Period 1 and insulin glargine via SoloSTAR pen in Period 2. |
| BG001 | Pen (Period 1) / Vial & Syringe (Period 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs) Score | Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained from summing responses to questions 1, 4, 5, 6, 7, and 8 and the total score can range from 0 to 36. Higher scores indicate higher satisfaction with diabetes treatment. | This analysis includes participants who completed the baseline and week 12 assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
Adverse events were collected from the time study treatment began through the completion of both 12-week periods of the study (up to 24 weeks). Twenty-five participants began the vial and syringe delivery method in Period 1 and 23 participants began this intervention in Period 2, resulting in 48 participants receiving this intervention. For the insulin pen delivery method, 24 participants began in Period 1 and 23 began in Period 2, for a total of 47 participants receiving this intervention.
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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 | Vial and Syringe | Participants, from both dosing sequences (Period 1 and Period 2), using a vial and syringe during the study to self-administer insulin. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment | Blood glucose <70mg/dL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Newton, MD | Emory University School of Medicine | 404-355-4393 | cnewton@atlantadiabetes.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| glargine via insulin pen | Device | oral antidiabetic agents plus insulin glargine in a pre-filled pen |
|
|
| Baseline, Week 12 |
| Fasting Blood Glucose | Blood sugar levels are influenced by the size and types of food consumed during the last meal and the production and response to insulin. Fasting blood glucose levels of less than 100 milligrams per deciliter (mg/dL) are considered normal. Values between 100 and 125 mg/dL indicate prediabetes and values of 126 mg/dL and higher indicate diabetes. Fasting blood glucose levels can lower depending on food consumed and medications. | Baseline, Week 12 |
| Percent of Participants With Dosing Errors | Percentage of participants who had dosing errors during the course of the study (both study periods). Participants were instructed on using each device and practiced preparing and injecting the insulin dose into a pillow to assess accuracy with each method of delivering insulin. Dosing errors were defined as inaccurate preparation or injection by less than or equal to 10% of the intended dose, independent of vision and dexterity function. | Week 24 |
| Number of Hypoglycemic Events | The number of hypoglycemic events occurring during the 24-week study period is reported here. For the purposes of this study, hypoglycemia is defined as a capillary and/or laboratory blood glucose value of less than 70 mg/dL. | Week 24 |
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|
Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Pen (Period 1) / Vial & Syringe (Period 2) | Crossover study group where participants were randomized to the sequence of insulin glargine via SoloSTAR® pen in Period 1 and insulin glargine via vial and syringe in Period 2. |
|
|
| Primary | Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score | Treatment satisfaction after crossover into the second treatment period was assessed using the Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc). The questionnaire contains eight items scored on a seven-point scale where -3 = much less satisfied now and 3 = much more satisfied now. The satisfaction score is obtained from summing responses to questions 1, and 4 through 8 (the remaining two items assess perceived blood sugar levels). The total score can range from -18 to 18. Higher scores indicate higher satisfaction with the new diabetes treatment, compared to prior treatment, while scores below 0 mean that satisfaction with the new delivery method of insulin in Period 2 is lower than satisfaction with the delivery method in Period 1. | This analysis includes participants who completed the week 12 and week 24 assessments. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
|
|
| Secondary | Hemoglobin A1c (HbA1c) | Hemoglobin A1c (HbA1c) measures the average percentage of blood sugar over the past 2 to 3 months. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. HbA1c can reduce with management of diabetes through diet, exercise, and medication. | Participants with HbA1c measurements at baseline and week 12 are included in this analysis. | Posted | Mean | Standard Deviation | percentage of Hemoglobin A1c | Baseline, Week 12 |
|
|
|
| Secondary | Fasting Blood Glucose | Blood sugar levels are influenced by the size and types of food consumed during the last meal and the production and response to insulin. Fasting blood glucose levels of less than 100 milligrams per deciliter (mg/dL) are considered normal. Values between 100 and 125 mg/dL indicate prediabetes and values of 126 mg/dL and higher indicate diabetes. Fasting blood glucose levels can lower depending on food consumed and medications. | Participants with fasting blood glucose measurements at baseline and week 12 are included in this analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12 |
|
|
|
| Secondary | Percent of Participants With Dosing Errors | Percentage of participants who had dosing errors during the course of the study (both study periods). Participants were instructed on using each device and practiced preparing and injecting the insulin dose into a pillow to assess accuracy with each method of delivering insulin. Dosing errors were defined as inaccurate preparation or injection by less than or equal to 10% of the intended dose, independent of vision and dexterity function. | All participants completing the study are included in this analysis (23 in dosing sequence 1 and 23 in dosing sequence 2). | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | Number of Hypoglycemic Events | The number of hypoglycemic events occurring during the 24-week study period is reported here. For the purposes of this study, hypoglycemia is defined as a capillary and/or laboratory blood glucose value of less than 70 mg/dL. | All participants completing the study are included in this analysis (23 in dosing sequence 1 and 23 in dosing sequence 2). | Posted | Number | hypoglycemic events | Week 24 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 22 |
| 48 |
| EG001 | SoloSTAR Pen | Participants, from both dosing sequences (Period 1 and Period 2), using the SoloSTAR Pen during the study to self-administer insulin. | 0 | 47 | 0 | 47 | 15 | 47 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |