Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

Diabetes Clinical Trial

Official title:

A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002768
• Other study ID #: NN1250-3538
• Secondary ID: U1111-1111-88432
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2009
• Last updated: January 19, 2017
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

• Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

• Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

• Smoker

• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
• insulin glargine
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Koehler G, Heller S, Korsatko S, Roepstorff C, Rasmussen S, Haahr H, Pieber TR. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossove — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration		Within 0-46 hours after last trial product administration
Secondary	Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose		Within 0-46 hours after last trial product administration
Secondary	Time from start of hypoglycaemic induction until each level of plasma glucose is reached		Within 0-46 hours after last trial product administration
Secondary	Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L		Within 0-46 hours after last trial product administration
Secondary	Hypoglycaemic symptoms score during recovery from hypoglycaemia		Within 0-46 hours after last trial product administration

External Links

•   Clinical Trials at Novo Nordisk