Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT00791895
  4. Details
NCT00791895 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00791895
Other study ID # BIASP-2174
Secondary ID
Status Completed
Phase Phase 4
First received November 13, 2008
Last updated February 22, 2017
Start date June 26, 2003
Est. completion date November 29, 2004

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date November 29, 2004
Est. primary completion date October 31, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart 30
Treat-to-target dose titration scheme

Locations
Country Name City State
United States Novo Nordisk Investigational Site Albany New York
United States Novo Nordisk Investigational Site Cleveland Ohio
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Deland Florida
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site La Jolla California
United States Novo Nordisk Investigational Site La Jolla California
United States Novo Nordisk Investigational Site Medford Oregon
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Milwaukee Wisconsin
United States Novo Nordisk Investigational Site Ogden Utah
United States Novo Nordisk Investigational Site Omaha Nebraska
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Renton Washington
United States Novo Nordisk Investigational Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):58-6 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of subjects achieving HbA1c below 6.5% after 16, 32 and 48 weeks, respectively
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2

External Links