A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin degludec

• Registration Number: NCT01154881
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index (BMI) below or equal to 35.0 kg/m2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDeg 200U/mL 0.6U/kg	insulin degludec	-
IDeg 100U/mL 0.4U/kg	insulin degludec	-
IDeg 100U/mL 0.8U/kg	insulin degludec	-
IDeg 100U/mL 0.6U/kg	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve from 0-24 hours at steady state	0-24 hours (derived on treatment day 6)

Secondary Outcome Measures

Name	Time	Method
Area under the insulin degludec concentration-time curve from 0-24 hours at steady state	0-24 hours (derived on treatment day 6)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany