NCT01486862

Brief Summary

This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_4 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

October 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5.4 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

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

December 5, 2011

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%

Secondary Outcomes (3)

  • Change in HbA1c

  • Total number of hypoglycemic events

  • Adverse events

Study Arms (1)

BIAsp 30

EXPERIMENTAL
Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks.

BIAsp 30

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus for at least 12 months
  • HbA1c between 7.5-14.5% (inclusive) at screening
  • Insulin naïve
  • An antidiabetic regimen that has been stable for at least 3 months prior to screening
  • An antidiabetic regimen that includes a minimum of 2 OADs

You may not qualify if:

  • Use of any insulin preparations within the past 6 months
  • Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Pachuca, 42060, Mexico

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

October 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

ME(1)