Phase 4
N=12
Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02680457 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE) — 75.2; 68.5 mg/dl — p=0.630
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin Degludec (Drug); Insulin Glargine (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Guadalajara
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE) |
75.2; 68.5 | 0.630 |
| SECONDARY Glycemic Variability: Area Under the Curve of Glucose |
46776; 46499 | 1.00 |
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.
Eligibility 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]
Data sourced from ClinicalTrials.gov (NCT02680457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.