DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Observational Study of NovoMix� 50 for Treatment of Type 2 Diabetics for 12 Months

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2

Intervention: biphasic insulin aspart 50 (Drug)

Phase: N/A

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Petra Sencar Bozic, MSc, Study Director, Affiliation: Novo Nordisk A/S

Summary

This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.

Clinical Details

Official title: A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Change in HbA1c

Secondary outcome:

Percentage of subjects achieving target HbA1c

Change in FPG (fasting plasma glucose)

Change in PPG (postprandial glucose)

Change in number of hypoglycaemic events

Change in insulin presentation

Dose and number of injections

Number of ADRs (adverse drug reaction)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes treated with biphasic human insulin with or without metformin

- Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the

physician's opinion, benefit from treatment with NovoMix® 50 Exclusion Criteria:

- Subjects with diagnosed type 1 diabetes mellitus

- Subjects treated with short acting or intermediate acting human insulin or any

insulin analogue

- Subjects who are unlikely to comply with study description, e. g. uncooperative

attitude, inability to come for regular visits

- Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to

any of the excipients

- Women of childbearing potential, who are pregnant, breast-feeding or intend to become

pregnant within next 12 months

Locations and Contacts

Ljubljana SI-1000, Slovenia
Additional Information

Clinical Trials at Novo Nordisk

Starting date: September 2008
Last updated: August 12, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017