Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effect of the Administration of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus Drug-naïve
Type 2 diabetes mellitus (T2DM) is characterized by wide fluctuations of glucose. The long-acting insulin has showed to improve glycemic variability however the behavior of insulin glargine versus insulin degludec is unknown.
Cross-over, double dummy, randomized, clinical trial was carried out. The sample size was
calculated using the formula for clinical trials of mean differences with an "n" of 6
patients per group was obtained. Patients between 30 and 65 years of age will be included
with T2DM, without hyperglycemic drugs, hemoglobin A1c (A1C) 6.5 to 11.0 % and with written
signature consent. They were assigned randomly by sealed envelope either to received insulin
Degludec (Novo Nordisk A/S. Bagsvaerd, Denmark) or insulin Glargine (Sanofi-Aventis
Deutschland GmbH. Frankfurt, Germany) [10 international units (IU) subcutaneous (SC) every 24
hours for six days], patients who were administered initially insulin Degludec corresponded
then insulin Glargine and vice versa, with a washout period of 14 days between each
intervention.
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.
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