A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569841
• Other study ID #: NN1250-3874
• Secondary ID: U1111-1125-7495
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2012
• Last updated: January 21, 2016
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• HbA1c (glycosylated haemoglobin) below or equal to 8.5%

• Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U

• BMI (body mass index) below 35 kg/m^2

Exclusion Criteria:

• Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues

• Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods

• Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1

• Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Administered subcutaneously (s.c., under the skin) once daily.
• insulin glargine
Administered subcutaneously (s.c., under the skin) once daily.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)	Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.	CGM occured during the last 2 weeks of the 6 weeks treatment period.	No
Secondary	Mean Interstitial Glucose (IG) Based on 14 Days of CGM	The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.	CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.	No
Secondary	Fasting Plasma Glucose (FPG)	FPG after 6 weeks of treatment in each treatment period.	At the end of each 6 week treatment period.	No
Secondary	Glycosylated Haemoglobin (HbA1c)	HbA1c after 6 weeks of treatment in each treatment period.	At the end of each 6 week treatment period.	No
Secondary	Number of Treatment Emergent Adverse Events (AEs)	Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.	Within each week 6 treatment period	No
Secondary	Number of Treatment Emergent Confirmed Hypoglycaemic Episodes	A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.	Hypoglycemic episodes reported within each 6 week treatment period.	No

External Links

•   Clinical Trials at Novo Nordisk