Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes

NCT00659282 | Completed

• 1 other identifier: BIASP-1766
• Study Type: observational
• Target: 57,610
• Locations: 11 countries
• Sites: 11

Brief Summary

This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of major hypoglycaemic events reported as serious adverse drug reactions

  during treatment

Study Arms (1)

A

biphasic insulin aspart

Drug: biphasic insulin aspart

Interventions

biphasic insulin aspart DRUG

Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.

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

A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from both general and speciality practice settings who have been deemed appropriate to receive NovoMix® 30 as new treatment and as part of routine out-patient care by the prescribing physician.

You may qualify if:

• Age according to approved label and physician discretion
• Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before

You may not qualify if:

• Subjects who previously enrolled in this study
• Subjects who are unlikely to comply with protocol requirements
• Hypersensitivity to biphasic insulin aspart or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (11)

Novo Nordisk Investigational Site

Mississauga, L4W 4XI, Canada

Location

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, 100004, China

Location

Novo Nordisk Investigational Site

Vouliagment, 16671, Greece

Location

Novo Nordisk Investigational Site

Bangalore, 560001, India

Location

Novo Nordisk Investigational Site

Tehran, Iran

Location

Novo Nordisk Investigational Site

Rome, 00144, Italy

Location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Novo Nordisk Investigational Site

Warsaw, PL-02-274, Poland

Location

Novo Nordisk Investigational Site

Moscow, 119330, Russia

Location

Novo Nordisk Investigational Site

Riyadh, 3542, Saudi Arabia

Location

Novo Nordisk Investigational Site

Seoul, 137-920, South Korea

Location

Related Publications (9)

• Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, Shah S, Shestakova M, Wenying Y; IMPROVE Study Group Expert Panel. The IMPROVE study--a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts. Int J Clin Pract. 2008 Nov;62(11):1809-19. doi: 10.1111/j.1742-1241.2008.01917.x. Epub 2008 Sep 22.

  PMID: 18811598 RESULT

• Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, Shah S, Shestakova M, Wenying Y; IMPROVE Study Group Expert Panel. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Int J Clin Pract. 2009 Mar;63(3):522-31. doi: 10.1111/j.1742-1241.2009.02002.x. Epub 2009 Jan 27.

  PMID: 19187170 RESULT

• Wenying Y, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, Shah S, Shestakova M, Ligthelm R, Valensi P; IMPROVE Study Group Expert Panel. Improved glycaemic control with BIAsp 30 in insulin-naive type 2 diabetes patients inadequately controlled on oral antidiabetics: subgroup analysis from the IMPROVE study. Curr Med Res Opin. 2009 Nov;25(11):2643-54. doi: 10.1185/03007990903276745.

  PMID: 19751116 RESULT

• Yang W, Gao Y, Liu G, Chen L, Fu Z, Zou D, Feng P, Zhao Z. Biphasic insulin aspart 30 as insulin initiation or replacement therapy: the China cohort of the IMPROVE study. Curr Med Res Opin. 2010 Jan;26(1):101-7. doi: 10.1185/03007990903364640.

  PMID: 19916705 RESULT

• Gumprecht J, Benroubi M, Borzi V, Kawamori R, Shaban J, Shah S, Shestakova M, Wenying Y, Ligthelm R, Valensi P; IMPROVE Study Group Expert Panel. Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE observational study. Int J Clin Pract. 2009 Jun;63(6):966-72. doi: 10.1111/j.1742-1241.2009.02064.x.

  PMID: 19504715 RESULT

• Ishii H, Iwase M, Seino H, Shuto Y, Atsumi Y. Assessment of quality of life in patients with type 2 diabetes mellitus before and after starting biphasic insulin aspart 30 (BIAsp 30) therapy: IMPROVE study in Japan. Curr Med Res Opin. 2011 Mar;27(3):643-50. doi: 10.1185/03007995.2010.551760. Epub 2011 Jan 21.

  PMID: 21250861 RESULT

• Shah S, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, Shestakova M, Wenying Y, Valensi P; IMPROVE Study Group Expert Panel. Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study. Int J Clin Pract. 2009 Apr;63(4):574-82. doi: 10.1111/j.1742-1241.2009.02012.x. Epub 2009 Feb 5.

  PMID: 19210701 RESULT

• Valensi P, Shaban J, Benroubi M, Kawamori R, Borzi V, Shah S, Wenying Y, Prusty V, Hansen JB, Gumprecht J; IMPROVE Study Expert Panel. Predictors of achieving HbA(1c) <7% and no hypoglycaemia 6 months after initiation of biphasic insulin aspart 30 in patients with type 2 diabetes in the IMPROVE study. Curr Med Res Opin. 2013 Jun;29(6):601-9. doi: 10.1185/03007995.2013.786692. Epub 2013 Apr 12.

  PMID: 23488447 RESULT

• Valensi P, Husemoen LLN, Weatherall J, Monnier L. Association of postprandial and fasting plasma glucose with HbA1c across the spectrum of glycaemic impairment in type 2 diabetes. Int J Clin Pract. 2017 Dec;71(12):e13041. doi: 10.1111/ijcp.13041. No abstract available.

  PMID: 29283504 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: September 11, 2006
• Primary Completion: November 15, 2008
• Study Completion: November 15, 2008
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

SA (1); JP (1); RU (1); KR (1); CA (1); GR (1); IR (1); PL (1); IT (1); CN (1); IN (1)