A Phase 4 interventional study of Glargine and glargine via insulin pen in Diabetes Mellitus, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Emory University · Phase 4, Interventional, and Treatment
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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Exclusion Criteria:
Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
Drug: Glargine · Device: glargine via insulin pen
Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
Drug: Glargine · Device: glargine via insulin pen
oral antidiabetic agents plus once daily insulin glargine via an insulin syringe
Also known as: Lantus
oral antidiabetic agents plus insulin glargine in a pre-filled pen
Also known as: Solostar
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.
Time frame: 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.
Time frame: Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 24
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.
| Milestone | Vial & Syringe (Period 1) / Pen (Period 2) | Pen (Period 1) / Vial & Syringe (Period 2) |
|---|---|---|
| Started | 25 | 24 |
| Completed | 23 | 23 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Milestone | Vial & Syringe (Period 1) / Pen (Period 2) | Pen (Period 1) / Vial & Syringe (Period 2) |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 23 |
| Not completed | 0 | 0 |
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.
| units on a scale | Vial & Syringe (Period 1) / Pen (Period 2) | Pen (Period 1) / Vial & Syringe (Period 2) |
|---|---|---|
| Baseline | 28.2 ± 7.0 | 31.5 ± 4.9 |
| Week 12 | 32.2 ± 5.2 | 34.2 ± 2.3 |
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.
| units on a scale | Vial & Syringe (Period 1) / Pen (Period 2) | Pen (Period 1) / Vial & Syringe (Period 2) |
|---|---|---|
| Diabetes Treatment Satisfaction Questionnaire: Change (DTSQc) Score | 16.4 ± 2.7 | -2.3 ± 10.0 |
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.
| percentage of Hemoglobin A1c | Vial & Syringe (Period 1) / Pen (Period 2) | Pen (Period 1) / Vial & Syringe (Period 2) |
|---|---|---|
| Baseline | 8.7 ± 1.1 | 8.5 ± 1.3 |
| Week 12 | 7.6 ± 0.8 | 7.6 ± 1.0 |
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.
| mg/dL | Vial & Syringe (Period 1) / Pen (Period 2) | Pen (Period 1) / Vial & Syringe (Period 2) |
|---|---|---|
| Baseline | 159 ± 47 | 157 ± 38 |
| Week 12 | 126 ± 19 | 134 ± 32 |
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.
| percentage of participants | Vial & Syringe | SoloSTAR Pen |
|---|---|---|
| Percent of Participants With Dosing Errors | 90 | 20 |
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.
| hypoglycemic events | Vial & Syringe | SoloSTAR Pen |
|---|---|---|
| Number of Hypoglycemic Events | 72 | 36 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vial and Syringe | 0/48 (0%) | 0/48 (0%) | 22/48 (45.8%) |
| SoloSTAR Pen | 0/47 (0%) | 0/47 (0%) | 15/47 (31.9%) |
| Event | Vial and Syringe | SoloSTAR Pen |
|---|---|---|
| HypoglycemiaEndocrine disorders | 22/48 | 15/47 |
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).
| Age, Continuous(years) | Vial & Syringe (Period 1) / Pen (Period 2) | Pen (Period 1) / Vial & Syringe (Period 2) | Total |
|---|---|---|---|
| Mean | 68.8 ± 5.8 | 70.6 ± 4.4 | 68.8 ± 5.4 |
| Sex: Female, Male(Participants) | Vial & Syringe (Period 1) / Pen (Period 2) | Pen (Period 1) / Vial & Syringe (Period 2) | Total |
|---|---|---|---|
| Female | 17 | 13 | 30 |
| Male | 6 | 10 | 16 |
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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