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The aim of the study is to determine differences in glycemic control between a basal-bolus scheme insulin and NPH scheme insulin in a population of hospitalized patients with type 2 diabetes in a Noncritical Care Facility in Mexico. Patients with a recent diagnosis of type 2 and patients on treatment with oral hypoglycaemic agents and insulin or only insulin were included.
The primary outcome of the study is to determine difference in efficacy and security between a basal-bolus scheme insulin and NPH scheme insulin in patients with type 2 diabetes hospitalized in non-critical areas in a hospital in Mexico
On the first 4 to 6 h, the use of NPH insulin present a pronounced action peak on the postprandial glucose metabolism, and the rest of its basal action last 12 to 18 h, its cover the postprandial requirements of the first two meals of the day (breakfast and lunch) administering 2/3 of the total dose, and the requirements for the dinner with 1/3 of the total dose at the night. This is considered a good scheme for handling hyperglycemia, and its possible to have less hypoglycemia episodes, which are possible if an ultra-rapid-acting insulin is added and adequate intake is not performed due to multiple factors related to hospitalization.
Today it is uncertain whether there is any clear benefit of using Glargine plus Lantus insulin over NPH insulin in hospitalized patients with type 2 diabetes. Currently, both Glargine and NPH based regimen is practiced in inpatient hospital facilities. Current practice of inpatient insulin regimen is based on the physicians familiarity with a particular insulin type and personal preference rather than evidenced based knowledge. Glargine plus ultrafast insulin are two types of insulin that are more expensive compared to NPH with incidental benefits in hospitalized patients. There are reports in the literature about the incidence of hypoglycemia with this scheme. The current research proposal is to compare these two schemes in the treatment of hospitalized patients with diabetes in a hospital of the second level of care in Mexico.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPH insulin group | Experimental | Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin |
|
| Glargine and Lispro insulin group | Active Comparator | Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro. Intervention drug: Glargine and Lispro |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPH insulin | Drug | NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | To determine the differences in the mean daily blood glucose measured in mg/dl, between a basal-bolus scheme and NPH schemes of insulin measured by the mean daily blood glucose. | Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| the Number of Participants With Mild and Severe Hypoglycemic Events | To measure the number of participants with mild and severe hypoglycemic events | Duration of hospital stay, up to 4 weeks. |
| Number of Participants With Sustained Glycemic Control During Hospital Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose A Alvarez, PhD | Universidad de Guanajuato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de León | León | Guanajuato | 37680 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21228246 | Background | Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12. | |
| 23435159 |
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Within the basal-bolus group, 1 patient was eliminated before initiating the insulin regimen, presenting acute abdomen and requiring intensive therapy. Therefore, 36 patients will start treatment in the basal-bolus group and 39 patients in the NPH group.
A total of 111 hospitalized DM2 patients not critical to the study were evaluated. Of these, 35 did not meet the inclusion criteria and the 75 included participants were randomized into two groups. The recruitment of patients began on November 2, 2017 and ended on June 1, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | NPH Insulin Group | Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. |
| FG001 | Glargine and Lispro Insulin Group | Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro. Intervention drug: Glargine and Lispro Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NPH Insulin Group | Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. | To determine the differences in the mean daily blood glucose measured in mg/dl, between a basal-bolus scheme and NPH schemes of insulin measured by the mean daily blood glucose. | Posted | Mean | Standard Deviation | mg/dl | Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 week |
|
4 weeks
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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 | NPH Insulin Group | Patients receiving NPH twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. If subjects were not eating, they shouldn't receive dose of NPH insulin. Intervention Drug: NPH insulin NPH insulin: NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soft tissue infection | Infections and infestations | Non-systematic Assessment |
Although the patients had an oral diet, the prolonged stay due to complications not associated with DM2 reduced their caloric intake.
The physiological scheme is more demanding, making it difficult to stick to the ideal conditions of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra. Paulina Crespo Morfin | University of Guanajuato | +52 4431300112 | pb.crespomorfin@outlook.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 2, 2019 | Nov 2, 2019 | Prot_SAP_ICF_000.pdf |
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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 |
|---|---|
| D007336 | Insulin, Isophane |
| D000069036 | Insulin Glargine |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Glargine and Lispro insulin | Drug | Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner. |
|
|
Sustained glycemic control were the number of participants who not had: discharged before sustained control, critical status suspension, death before control, bad attachment to the protocol, interruption due to more than 2 hypoglycemic events during their hospital stay. |
| blood glucose was taken every day, up to 4 weeks. |
| Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22. |
| 28067472 | Background | Christensen MB, Gotfredsen A, Norgaard K. Efficacy of basal-bolus insulin regimens in the inpatient management of non-critically ill patients with type 2 diabetes: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2017 Jul;33(5). doi: 10.1002/dmrr.2885. Epub 2017 Feb 23. |
| Protocol Violation |
|
| Physician Decision |
|
| BG001 | Glargine and Lispro Insulin Group | Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro. Intervention drug: Glargine and Lispro Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Central glucose | Measurement of central glucose levels on admission (mg/dl). | Mean | Standard Deviation | mg / dl |
|
| OG001 | Glargine and Lispro Insulin Group | Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro. Intervention drug: Glargine and Lispro Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner. |
|
|
| Secondary | the Number of Participants With Mild and Severe Hypoglycemic Events | To measure the number of participants with mild and severe hypoglycemic events | Posted | Count of Participants | Participants | Duration of hospital stay, up to 4 weeks. |
|
|
|
| Secondary | Number of Participants With Sustained Glycemic Control During Hospital Stay | Sustained glycemic control were the number of participants who not had: discharged before sustained control, critical status suspension, death before control, bad attachment to the protocol, interruption due to more than 2 hypoglycemic events during their hospital stay. | Posted | Count of Participants | Participants | blood glucose was taken every day, up to 4 weeks. |
|
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|
| 1 |
| 39 |
| 0 |
| 39 |
| 15 |
| 39 |
| EG001 | Glargine and Lispro Insulin Group | Half of the total of Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose will be given as Lispro; doses were divided equally for breakfast, lunch, and dinner. An additional correctional dose of Lispro will be given for any blood glucose >180 mg/dL. If subjects were not eating, they received glargine once daily and they shouldn't receive doses of lispro. Intervention drug: Glargine and Lispro Glargine and Lispro insulin: Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner. | 1 | 36 | 0 | 36 | 11 | 36 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |