NCT01487811

Brief Summary

This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

December 5, 2011

Last Update Submit

January 5, 2017

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity

  • Maximum drug concentration of the two formulations (Cmax)

Secondary Outcomes (3)

  • Area under the concentration curve for insulin aspart from time 0 hours to 16 hours

  • Mean residence time (MRT)

  • Frequency of adverse events

Study Arms (2)

Formulation 1

EXPERIMENTAL
Drug: biphasic insulin aspart 30

Formulation 2

ACTIVE COMPARATOR
Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Single dose administrated subcutaneously (s.c., under the skin)

Formulation 1Formulation 2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI (body mass index) between 18 and 28 kg/m\^2, both inclusive
  • Subject is a nonsmoker for at least 3 months
  • Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
  • Fasting plasma glucose between 80 and 110 mg/dl

You may not qualify if:

  • Any clinically significant disease history of systemic or organ disease
  • Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
  • In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

  • Hanefeld M, Fischer S, Julius U, Schulze J, Schwanebeck U, Schmechel H, Ziegelasch HJ, Lindner J. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia. 1996 Dec;39(12):1577-83. doi: 10.1007/s001250050617.

    PMID: 8960845RESULT

  • Standl E, Balletshofer B, Dahl B, Weichenhain B, Stiegler H, Hormann A, Holle R. Predictors of 10-year macrovascular and overall mortality in patients with NIDDM: the Munich General Practitioner Project. Diabetologia. 1996 Dec;39(12):1540-5. doi: 10.1007/s001250050612.

    PMID: 8960840RESULT

  • The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial. Diabetes. 1996 Oct;45(10):1289-98.

    PMID: 8826962RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

May 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

US(1)