NCT01028404

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Nov 2009

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

December 7, 2009

Last Update Submit

July 24, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Healthy

Outcome Measures

Primary Outcomes (2)

  • Number and severity of adverse events for trial part 1

    from visit 1 to visit 3

  • Number and severity of adverse events for trial part 2

    from visit 1 to visit 6

Secondary Outcomes (2)

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

    after 12 hours

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

    after 12 hours

Study Arms (2)

Trial part 1

EXPERIMENTAL
Drug: NN1952Drug: insulin aspartDrug: placebo

Trial part 2

EXPERIMENTAL
Drug: NN1952Drug: insulin aspartDrug: placebo

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.

Trial part 1
insulin aspartDRUG

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

Trial part 1
placeboDRUG

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

Trial part 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

DE(1)