Clinical trial NCT00791895: Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-11-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects achieving HbA1c below 6.5%
timeFrame: after 16, 32 and 48 weeks, respectively
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: La Jolla
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Deland
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Wichita
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Medford
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Ogden
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Garber AJ, Wahlen J, Wahl T, Bressler P, Braceras R, Allen E, Jain R. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study). Diabetes Obes Metab. 2006 Jan;8(1):58-66. doi: 10.1111/j.1463-1326.2005.00563.x.