Trial Outcomes & Findings for Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus (NCT NCT02680457)

Last Updated: 2020-09-28

Results Overview

Mean amplitude of interstitial glucose excursions (MAGE) during the last 48 h of the ambulatory continuous glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge); starting in the day 3 of the administration of insulin degludec or glargine

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

2 days

Results posted on

2020-09-28

Participant Flow

Total number of patients: 12 in a crossover intervention. Interventions: 2. Washout period before the cross-over intervention. Protocol violations were detected at the end of the study in patients of both groups

Participant milestones

Participant milestones
Measure	Insulin Degludec - Insulin Glargine Insulin Degludec: 10 IU subcutaneous (SC) every 24 hours for 6 days Washout period for 14 days Insulin Glargine 10 IU SC every 24 hours for 6 days	Insulin Glargine - Insulin Degludec Insulin Glargine: 10 IU subcutaneous (SC) every 24 hours for 6 days Washout period for 14 days Insulin Degludec 10 IU SC every 24 hours for 6 days
Initial Intervention STARTED	6	6
Initial Intervention COMPLETED	6	6
Initial Intervention NOT COMPLETED	0	0
Washout Period STARTED	6	6
Washout Period COMPLETED	6	6
Washout Period NOT COMPLETED	0	0
Cross-over Intervention STARTED	6	6
Cross-over Intervention COMPLETED	6	6
Cross-over Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Total Group n=12 Participants Total Group of Patients with Type 2 Diabetes mellitus
Age, Continuous	44.1 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Weight	80.5 kg STANDARD_DEVIATION 13.3 • n=5 Participants
Body Mass Index	32.1 kg/m^2 STANDARD_DEVIATION 2.5 • n=5 Participants
Systolic Blood Pressure	114.8 mmHg STANDARD_DEVIATION 8.1 • n=5 Participants
Diastolic Blood Pressure	75.8 mmHg STANDARD_DEVIATION 6.4 • n=5 Participants
Hemoglobin A1c	8.2 % of Hemoglobin A1c STANDARD_DEVIATION 1.4 • n=5 Participants
Fasting Plasma Glucose	181 mg/dl STANDARD_DEVIATION 59.8 • n=5 Participants
Uric Acid	4.6 mg/dl STANDARD_DEVIATION 1.4 • n=5 Participants
Creatinine	0.7 mg/dl STANDARD_DEVIATION 0.2 • n=5 Participants
Total Cholesterol	174.8 mg/dl STANDARD_DEVIATION 29.5 • n=5 Participants
High-density lipoprotein-cholesterol (HDL-C)	42.3 mg/dl STANDARD_DEVIATION 9.4 • n=5 Participants
Low-density lipoprotein-cholesterol (LDL-C)	92.6 mg/dl STANDARD_DEVIATION 27.9 • n=5 Participants
Triglycerides	199.3 mg/dl STANDARD_DEVIATION 84.5 • n=5 Participants
Aspartate aminotransferase (AST)	25.8 mg/dl STANDARD_DEVIATION 11.3 • n=5 Participants
Alanine aminotransferase (ALT)	41.6 mg/dl STANDARD_DEVIATION 25.9 • n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Population: Comparison between both interventions. There are not baseline values of this measurements due to a design error. There were technical problems with the measurements.

Outcome measures

Outcome measures
Measure	Insulin Degludec n=12 Participants Patients who received: Insulin Degludec: 10 IU SC every 24 hours for 6 days, from both arms of the study	Insulin Glargine n=12 Participants Patients who received: Insulin Glargine: 10 IU SC every 24 hours for 6 days, from both arms of the study
Glycemic Variability: Mean Amplitude of Glucose Excursion (MAGE)	75.2 mg/dl Standard Deviation 38.9	68.5 mg/dl Standard Deviation 47.4

SECONDARY outcome

Timeframe: Every 5 min for 24 hours on day 5 post-dose

Population: Area Under the Curve of Glucose in a patient (Insulin Degludec group) could not be calculated. There are not baseline values of this measurements due to a design error. There were technical problems with the measurements.

Area under the curve of glucose of the second day of continuous ambulatory glucose monitoring of 3 days (Guardian®, Medtronic MiniMed, Northridge)

Outcome measures

Outcome measures
Measure	Insulin Degludec n=11 Participants Patients who received: Insulin Degludec: 10 IU SC every 24 hours for 6 days, from both arms of the study	Insulin Glargine n=12 Participants Patients who received: Insulin Glargine: 10 IU SC every 24 hours for 6 days, from both arms of the study
Glycemic Variability: Area Under the Curve of Glucose	46776 mg*h/dL Standard Deviation 17860	46499 mg*h/dL Standard Deviation 16971

Adverse Events

Insulin Degludec

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Insulin Glargine

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Insulin Degludec n=12 participants at risk Patients with Type 2 Diabetes mellitus Insulin Degludec: 10 IU SC every 24 hours for 6 days	Insulin Glargine n=12 participants at risk Patients with Type 2 Diabetes mellitus Insulin Glargine: 10 IU SC every 24 hours for 6 days
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months	25.0% 3/12 • Number of events 3 • From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months
Nervous system disorders Lower limb paresthesias	8.3% 1/12 • Number of events 1 • From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months	33.3% 4/12 • Number of events 4 • From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months
Gastrointestinal disorders Flatulence	8.3% 1/12 • Number of events 1 • From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months	0.00% 0/12 • From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months
Endocrine disorders Mild hypoglycemia	25.0% 3/12 • Number of events 3 • From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months	16.7% 2/12 • Number of events 2 • From the beginning of the study until a month after the end of the intervention for each patient, an average of 2 months

Additional Information

Dr. Manuel González Ortiz

Instituto de Terapéutica Experimental y Clínica, Universidad de Guadalajara

Phone: +52 3310585200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place