NCT00791895|CompletedPhase 4

Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs

NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) Titrate-To-Target: An Observational Study of the Efficacy of NovoLog® Mix 70/30 in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets on OADs With / Without Once Daily Basal Insulin Therapy

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

BIASP-2174

Study Type

interventional

Target

102

Locations

1 country

Sites

Timeline

RegisteredNov 2008

StartedJun 2003

CompletionNov 2004

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

102

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline

Completed

Started Jun 2003

Geographic Reach

1 country

15 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.4 years study duration

Study Start

First participant enrolled

June 26, 2003

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2004

Completed

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2004

Completed

4 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed

Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

November 13, 2008

Last Update Submit

February 22, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Percentage of subjects achieving HbA1c below 6.5%
after 16, 32 and 48 weeks, respectively

Study Arms (1)

A

EXPERIMENTAL

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Treat-to-target dose titration scheme

Also known as: BIASP, NovoLog® Mix 70/30, NovoMix®

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: 7.5-10.0%
An antidiabetic regimen that has been stable for at least 3 months
Able and willing to perform SMBG testing as per protocol

You may not qualify if:

Use of any insulin preparations other than NPH or glargine within the past 6 months
Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)
Known or suspected allergy to trial product or agents related to trial product

Contact the study team to confirm eligibility.