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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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In this study the investigators would like to test the hypothesis that in diabetic patients discharged from the hospital, SoloSTAR Glargine insulin will be superior to syringe-injected Glargine in terms of diabetes control, compliance, and patient satisfaction and preference. The investigators will test this hypothesis in a randomized, crossover trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pen-administered vs syringe-admnistered Glargine | Active Comparator | SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin |
|
| Syringe-administered vs pen-administered Glargine | Active Comparator | Syringe-administered Glargine insulin and then pen-administered Glargine insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glargine insulin | Drug | 20-180 units per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c at Three Months of Each Period of Treatment | Data was collected by group | Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance and Patient Satisfaction | 6 months of treatment after discharge from the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Draznin, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
Although this is a crossover study, no information is available on the participants that completed phase 1 and started phase 2, and so these milestones are not included. Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study. The number of participants started and completed reflects the participants confirmed to have started and completed the study. 43 participants were consented.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pen-administered, Then Syringe-admnistered Glargine | SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin Glargine insulin: 20-180 units per day |
| FG001 | Syringe-administered Then Pen-administered Glargine | Syringe-administered Glargine insulin and then pen-administered Glargine insulin Glargine insulin: 20-180 units per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants are grouped into a single arm because no demographics information regarding the separate arms exists. Consented participants that did not complete the study cannot be excluded. Multiple attempts were made to obtain more precise data, however the PI has retired and neither he nor any members of the study team or other contacts associated with the study were able to locate the data.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Pen-administered, then syringe-admnistered Glargine Group (1) AND Syringe-administered then pen-administered Glargine Group (2) Group 1: SoloSTAR pen-administered Glargine insulin then syringe-administered Glargine insulin Glargine insulin: 20-180 units per day Group 2: Syringe-administered Glargine insulin and then pen-administered Glargine insulin Glargine insulin: 20-180 units per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | HbA1c at Three Months of Each Period of Treatment | Data was collected by group | The only outcome measure available for this measurement is "by group". This measure cannot be entered "by intervention" (e.g. Arm 1: "Pen", Arm 2: "Syringe"). Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study. Participants that did not complete the study are not included. | Posted | Mean | Standard Deviation | percentage (DCCT unit) | Baseline, Month 3 (End of Intervention 1), Month 6 (End of intervention 2) |
|
6 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 | Pen-administered Glargine | Glargine insulin: 20-180 units per day | 0 |
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Limited results information is available. Multiple attempts were made to obtain this information, however the PI is retired and additional data could not be obtained from any remaining personnel associated with the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Administration | University of Colorado Denver | 3037241111 | clinicalresearchsupportcenter@ucdenver.edu |
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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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Group 2: Syringe-administered Then Pen-administered Glargine |
Syringe-administered Glargine insulin and then pen-administered Glargine insulin Glargine insulin: 20-180 units per day |
|
|
| Secondary | Compliance and Patient Satisfaction | No data is available for this outcome measure. Multiple attempts were made to obtain this information, however the PI is retired and data could not be obtained from any remaining personnel associated with the study. | Posted | 6 months of treatment after discharge from the hospital |
|
|
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Syringe-administered Glargine | Glargine insulin: 20-180 units per day | 0 | 31 | 0 | 31 | 0 | 31 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |