A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 1

Healthy

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin aspart

Drug: NN1952

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01028404

U1111-1112-2892 (Other Identifier)

2009-013282-26 (EudraCT Number)

NN1952-3646

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.

The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.

Enrollment

84 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

FOR TRIAL PART 1, THE FOLLOWING APPLIES:
Gender: male
Age: 18-55 years
BMI (body mass index): 18-28 kg/m2
Study participants considered to be healthy
FOR TRIAL PART 2, THE FOLLOWING APPLIES:
Gender: male or female of no childbearing potential
Age: 18-65 years
Type 1 diabetes: BMI (body mass index): 18-28 kg/m2
Type 2 diabetes: BMI (body mass index): 22-35 kg/m2
Type 1 or type 2 diabetes for at least 12 months
Type 1 diabetes: Treatment with insulin for at least 12 months
Type 2 diabetes: Treatment with insulin for at least 3 months

Exclusion criteria

Known or suspected allergy to the trial product or related products
Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator
Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)