Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2017-11-02
2018-07-01
Brief Summary
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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
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of type 2 diabetes mellitus (DM2) or that upon admission is diagnosed by values of glycated haemoglobin (HbA1) \> 6.5%
* Fasting central glucose before randomization between 140mg/dl and 400mg/dl
* Non-critical patients hospitalized in the service of Internal Medicine (MI), General Surgery (CG) and Traumatology (TyO).
* Patients receiving a diabetic diet orally
* Treated with diet alone, o any combination of oral anti-diabetic agents or insulin treatment with any dosage before admission.
Exclusion Criteria
* Hyperglycemia without a known history of diabetes
* Impaired renal function (glomerular filtration rate less than 30)
* Diabetic ketoacidosis and hyperosmolar state
* Type 1 Diabetes mellitus
* Pregnancy
* Patients on treatment with more than 10mg prednisone or steroid boluses.
* Known hypopituitarism or adrenal insufficiency
* Hyperglycaemia due to stress (negative antecedent of DM2, hyperglycemia and HbA1 \<6.5)
* Severe liver disease (Child-Pugh C score)
* Acute pancreatitis
* Patients with sepsis or multiple organ failure
* Candidates for intensive care unit
18 Years
100 Years
ALL
No
Sponsors
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Universidad de Guanajuato
OTHER
Responsible Party
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Jose Antonio de Jesus Alvarez Canales
PhD
Principal Investigators
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Jose A Alvarez, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Guanajuato
Locations
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Hospital General de León
León, Guanajuato, Mexico
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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SSGTO00136
Identifier Type: -
Identifier Source: org_study_id