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NCT Number: NCT01028404

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NN1952

Drug

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 aspart

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number and severity of adverse events for trial part 1

    Time frame: from visit 1 to visit 3

  2. Number and severity of adverse events for trial part 2

    Time frame: from visit 1 to visit 6

Secondary outcomes

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

    Time frame: after 12 hours

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

    Time frame: after 12 hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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