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

Novo Nordisk A/S49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin degludecDRUG

Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Neuss, Germany

Outcomes

Primary Outcomes

Area under the glucose infusion rate curve from 0-24 hours at steady state

Time frame: 0-24 hours (derived on treatment day 6)

Secondary Outcomes

Area under the insulin degludec concentration-time curve from 0-24 hours at steady state

Time frame: 0-24 hours (derived on treatment day 6)

Data from ClinicalTrials.gov

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