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

Novo Nordisk A/S84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Healthy

Interventions

NN1952DRUG

Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.

insulin aspartDRUG

As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.

placeboDRUG

Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.

NN1952DRUG

Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.

insulin aspartDRUG

As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.

placeboDRUG

Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number and severity of adverse events for trial part 1

Time frame: from visit 1 to visit 3

Number and severity of adverse events for trial part 2

Time frame: from visit 1 to visit 6

Secondary Outcomes

Area under the serum insulin concentration-time curve after a single dose

Time frame: after 12 hours

Area under the glucose infusion rate-time curve after a single dose