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| ID | Type | Description | Link |
|---|---|---|---|
| U54RR014616 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Insulin glargine QHS | Experimental | Insulin glargine injected subcutaneously once daily at bedtime |
|
| 2 - Insulin glargine QAM | Experimental | Insulin glargine injected subcutaneously once daily in the morning |
|
| 3 - NPH Insulin QHS | Active Comparator | NPH insulin injected subcutaneously once daily at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1- Insulin glargine QHS | Drug | Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c Change From Baseline | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Glucose Readings < 130 mg/dL | Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL | 6 months |
| Frequency of Total Hypoglycemic Reactions | Frequency of hypoglycemic reactions without regard to time of occurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Hsia, MD | Charles Drew University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles Drew University of Medicine and Science | Los Angeles | California | 90059 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33166419 | Derived | Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4. | |
| 21146881 | Derived | Hsia SH. Insulin glargine compared to NPH among insulin-naive, U.S. inner city, ethnic minority type 2 diabetic patients. Diabetes Res Clin Pract. 2011 Mar;91(3):293-9. doi: 10.1016/j.diabres.2010.11.028. Epub 2010 Dec 13. |
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Baseline run-in period to document baseline control and reinforce dietary/lifestyle principles.
23 subjects not randomized due to protocol violations, loss to follow-up, lack of need for insulin, or voluntarily.
Recruitment occurred from Sep 2002 to Feb 2009. Subjects recruited from a diabetes specialty referral clinic, as well as from primary care clinics and through advertising in the South Los Angeles area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Glargine at Bedtime | Bedtime insulin glargine titrated to morning fasting glucose readings |
| FG001 | Insulin Glargine in AM | Morning insulin glargine titrated to pre-supper glucose readings |
| FG002 | NPH Insulin | Bedtime NPH insulin titrated to morning fasting glucose readings |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Glargine at Bedtime | Bedtime insulin glargine titrated to morning fasting glucose readings |
| BG001 | Insulin Glargine in AM | Morning insulin glargine titrated to pre-supper glucose readings |
| 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 | Hemoglobin A1c Change From Baseline | ITT (LOCF) | Posted | Sep 2010 | Mean | Standard Deviation | Percent | Baseline to 6 months |
|
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 | Insulin Glargine at Bedtime | Bedtime insulin glargine titrated to morning fasting glucose readings |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot Infection (Hospitalization) | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic Hypoglycemia | Endocrine disorders | Systematic Assessment | Classic symptoms of hypoglycemia, relieved by carbohydrate ingestion, with or without a corroborating self-monitored glucose reading |
Early termination leading to smaller than anticipated enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stanley H. Hsia, MD | Charles R. Drew University of Medicine and Science | 323-357-3633 | stanleyhsia@cdrewu.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016568 | Drugs, Generic |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| 2 - Insulin glargine QAM | Drug | Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL) |
|
|
| 3 - NPH insulin QHS | Drug | NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL) |
|
|
| 6 months |
| Frequency of Severe Hypoglycemic Reactions | Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person | 6 months |
| Body Mass Index Change From Baseline | Change in body mass index from baseline BMI measurement | 6 months |
| Total Daily Insulin Dose | Total daily number of units of insulin used | 6 months |
| Any Adverse Event Other Than Hypoglycemia | Any reported adverse event that is not hypoglycemia | 6 months |
| Adverse Event |
|
| BG002 | NPH Insulin | Bedtime NPH insulin titrated to morning fasting glucose readings |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | Percent |
|
| Diabetes Duration | Mean | Standard Deviation | Years |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Frequency of Glucose Readings < 130 mg/dL | Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL | Enrolled subjects | Posted | Mean | Standard Deviation | percentage of readings | 6 months |
|
|
|
| Secondary | Frequency of Total Hypoglycemic Reactions | Frequency of hypoglycemic reactions without regard to time of occurrence | Enrolled subjects | Posted | Mean | Standard Deviation | Hypoglycemic events per patient | 6 months |
|
|
|
| Secondary | Frequency of Severe Hypoglycemic Reactions | Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person | Enrolled subjects | Posted | Number | Severe hypoglycemic events | 6 months |
|
|
|
| Secondary | Body Mass Index Change From Baseline | Change in body mass index from baseline BMI measurement | Enrolled subjects | Posted | Mean | Standard Deviation | kg per square meter | 6 months |
|
|
|
| Secondary | Total Daily Insulin Dose | Total daily number of units of insulin used | Enrolled subjects | Posted | Mean | Standard Deviation | Units of insulin per day | 6 months |
|
|
|
| Secondary | Any Adverse Event Other Than Hypoglycemia | Any reported adverse event that is not hypoglycemia | Enrolled subjects | Posted | Number | Events | 6 months |
|
|
|
| 0 |
| 30 |
| 23 |
| 30 |
| EG001 | Insulin Glargine in AM | Morning insulin glargine titrated to pre-supper glucose readings | 1 | 25 | 24 | 25 |
| EG002 | NPH Insulin | Bedtime NPH insulin titrated to morning fasting glucose readings | 0 | 30 | 23 | 30 |
|
| Asymptomatic Retinal Hemorrhage | Eye disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |