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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01028404
First received: December 7, 2009
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Healthy
Drug: NN1952
Drug: insulin aspart
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number and severity of adverse events for trial part 1 [ Time Frame: from visit 1 to visit 3 ] [ Designated as safety issue: Yes ]
  • Number and severity of adverse events for trial part 2 [ Time Frame: from visit 1 to visit 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the serum insulin concentration-time curve after a single dose [ Time Frame: after 12 hours ] [ Designated as safety issue: No ]
  • Area under the glucose infusion rate-time curve after a single dose [ Time Frame: after 12 hours ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trial part 1 Drug: NN1952
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.
Drug: insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
Drug: placebo
Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
Experimental: Trial part 2 Drug: NN1952
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.
Drug: insulin aspart
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.
Drug: placebo
Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028404

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Inge Birk Halberg, DDS, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01028404     History of Changes
Other Study ID Numbers: NN1952-3646, U1111-1112-2892, 2009-013282-26
Study First Received: December 7, 2009
Last Updated: July 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014