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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00791895

Enrollment

102

Registered

2008-11-17

Start date

2003-06-26

Completion date

2004-11-29

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGbiphasic insulin aspart 30

Treat-to-target dose titration scheme

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026