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

Diabetes Mellitus, Type 2 Clinical Trial

— IMPROVE™  

Official title:

Observational Study of Safety and Effectiveness of NovoMix® 30 (Biphasic Insulin Aspart) for the Treatment of Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659282
• Other study ID #: BIASP-1766
• Status: Completed
• Phase: N/A
• First received: April 10, 2008
• Last updated: January 11, 2018
• Start date: September 11, 2006
• Est. completion date: November 15, 2008

Study information

• Verified date: January 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57610
• Est. completion date: November 15, 2008
• Est. primary completion date: November 15, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart
Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Mississauga
China	Novo Nordisk Investigational Site	Beijing	Beijing
Greece	Novo Nordisk Investigational Site	Vouliagment
India	Novo Nordisk Investigational Site	Bangalore
Iran, Islamic Republic of	Novo Nordisk Investigational Site	Teheran
Italy	Novo Nordisk Investigational Site	Rome
Japan	Novo Nordisk Investigational Site	Tokyo
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Poland	Novo Nordisk Investigational Site	Warszawa
Russian Federation	Novo Nordisk Investigational Site	Moscow
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Canada,  China,  Greece,  India,  Iran, Islamic Republic of,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Saudi Arabia, 

References & Publications (9)

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 pati — View Citation

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 — View Citation

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 patien — View Citation

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 — View Citation

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 — View Citation

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). doi: 10.1111/ijcp.13041. — View Citation

Valensi P, Shaban J, Benroubi M, Kawamori R, Borzì 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 pati — View Citation

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-naïve type 2 diabetes patients inadequately controlled on — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major hypoglycaemic events reported as serious adverse drug reactions		during treatment

External Links

•   Clinical Trials at Novo Nordisk