A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01114542

Collaborator

(none)

Enrollment

Location

Arms

3.3

Actual Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: insulin degludec Drug: insulin glargine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

Actual Study Start Date :

May 3, 2010

Actual Primary Completion Date :

Aug 10, 2010

Actual Study Completion Date :

Aug 10, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDeg 0.4 U/kg	Drug: insulin degludec Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
Experimental: IDeg 0.6 U/kg	Drug: insulin degludec Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
Experimental: IDeg 0.8 U/kg	Drug: insulin degludec Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
Active Comparator: IGlar 0.4 U/kg	Drug: insulin glargine Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
Active Comparator: IGlar 0.6 U/kg	Drug: insulin glargine Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
Active Comparator: IGlar 0.8 U/kg	Drug: insulin glargine Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)

Outcome Measures

Primary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state [0-24 hours after dosing on day 8]

Secondary Outcome Measures

Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state [0-24 hours after dosing on day 8]
Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec [0-24 hours after dosing on day 8]
Area under the concentration-time curve during one dosing interval at steady state for insulin glargine [0-24 hours after dosing on day 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Current total daily insulin treatment lower than 1.2 (I)U/kg/day
Body mass index 18.0-28.0 kg/m^2

Exclusion Criteria:

Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic