Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT02680457
Last Updated: 2020-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2013-11-30
2016-11-30
Brief Summary
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Detailed Description
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The clinical findings and laboratory tests included a metabolic profile and biosafety, which will be made at baseline. Body weight, body mass index and blood pressure were performed during the initial visit, likewise, interstitial glucose concentrations by ambulatory continuous glucose monitoring system (Guardian®, Medtronic MiniMed, Northridge), through which the mean amplitude of glucose excursions (MAGE) and area under the curve of glucose were calculated, which served to assess the glycemic variability. Adverse events and adherence to treatment are documented. Statistical analysis: Mann-Whitney U test, Chi2, Fisher exact test. It is considered with significance at p \<0.05.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Insulin Degludec - Insulin Glargine
Insulin Degludec 10 IU SC every 24 hours for 6 days Washout for 14 days Insulin Glargine 10 IU SC every 24 hours for 6 days
Insulin Degludec
Insulin Degludec 10 IU SC every 24 hours for 6 days
Insulin Glargine
Insulin Glargine 10 IU SC every 24 hours for 6 days
Insulin Glargine - Insulin Degludec
Insulin Glargine 10 IU SC every 24 hours for 6 days Washout for 14 days Insulin Degludec 10 IU SC every 24 hours for 6 days
Insulin Degludec
Insulin Degludec 10 IU SC every 24 hours for 6 days
Insulin Glargine
Insulin Glargine 10 IU SC every 24 hours for 6 days
Interventions
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Insulin Degludec
Insulin Degludec 10 IU SC every 24 hours for 6 days
Insulin Glargine
Insulin Glargine 10 IU SC every 24 hours for 6 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fasting plasma glucose ≤300 mg/dL at the time of scrutiny
* A1C between 6.5 and 11%
* Written informed consent
Exclusion Criteria
* Untreated thyroid disease and/or uncontrolled hypertension \[≥150 systolic and diastolic ≥90\]
* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose. In the case of antihypertensives, these may be included if treatment was not modified previous 3 months and no change during the study.
* Total cholesterol \>240 mg/dL
* Triglycerides ≥400 mg/dL
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than twice the normal range
* Glomerular filtration rate \<60 mL/min \[Cockcroft-Gault\]
30 Years
65 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Responsible Party
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Manuel González Ortiz
PhD
Principal Investigators
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MANUEL GONZALEZ, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Guadalajara
Locations
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Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico
Countries
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Other Identifiers
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CT-DG-140282-JLRN
Identifier Type: -
Identifier Source: org_study_id
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