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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

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)