Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709683
• Other study ID #: BIASP-3572
• Status: Completed
• Phase: N/A
• First received: July 1, 2008
• Last updated: March 4, 2016
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Department of Medicine and Pharmacy
• Study type: Observational

Clinical Trial Summary

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes having failed on basal insulin with or without OAD

• HbA1c greater than 7.0%

Exclusion Criteria:

• Subjects being unlikely to comply with protocol requirements

• Subjects who previously enrolled in this study

• Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients

• Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major hypoglycaemic events reported as serious adverse drug reactions		during 26 weeks of treatment	Yes
Secondary	Number of serious adverse drug reactions		during 26 weeks of treatment	Yes
Secondary	Number of serious adverse events		during 26 weeks of treatment	Yes
Secondary	Number of all major (daytime and nocturnal) hypoglycaemic events		during 26 weeks of treatment	Yes
Secondary	Number of all minor (daytime and nocturnal) hypoglycaemic events		during 26 weeks of treatment	Yes
Secondary	Weight (BMI) change from baseline		At the end of the study	Yes
Secondary	HbA1c change from baseline		At the end of the study	No
Secondary	Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%		At the end of the study	No
Secondary	Average (mean) fasting plasma glucose level		At the end of the study	No
Secondary	Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level		At the end of the study	No

External Links

•   Clinical Trials at Novo Nordisk