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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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]