Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus

University of Guadalajara

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin Degludec; Drug: Insulin Glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT02680457

CT-DG-140282-JLRN

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with T2DM without treatment for at least 3 months Body mass index (BMI) from 25.0-34.9 kg/m2 Diagnosis of T2DM
• Fasting plasma glucose ≤300 mg/dL at the time of scrutiny
• A1C between 6.5 and 11%
• Written informed consent

Exclusion criteria

• Women pregnant or breastfeeding
• 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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Insulin Degludec - Insulin Glargine

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Glargine

Drug: Insulin Degludec

Insulin Glargine - Insulin Degludec

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Glargine

Drug: Insulin Degludec