Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes (EFFECTIVE)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00699179
First received: June 13, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c from baseline [ Time Frame: After 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus [ Time Frame: after 12 weeks and 26 weeks compared to baseline ] [ Designated as safety issue: No ]
  • Change in FPG (glucose variability) [ Time Frame: after 12 weeks and 26 weeks compared to baseline ] [ Designated as safety issue: No ]
  • Change in PPG (postprandial control) [ Time Frame: after 12 weeks and 26 weeks compared to baseline ] [ Designated as safety issue: No ]
  • Change in insulin dose and number of injections [ Time Frame: at 12 weeks and 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study [ Time Frame: after 12 weeks and 26 weeks of treatment compared to baseline ] [ Designated as safety issue: No ]
  • Change in body weight and waist circumference [ Time Frame: at 12 weeks and 26 weeks of treatment compared to baseline ] [ Designated as safety issue: No ]
  • Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits [ Time Frame: at 12 weeks and 26 weeks of treatment compared to baseline ] [ Designated as safety issue: Yes ]
  • Number of adverse drug reactions (ADR) [ Time Frame: after 12 weeks and 26 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 2308
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.
Other Name: NovoMix® 30

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 1 and 2 diabetes

Criteria

Inclusion Criteria:

  • Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months
  • HbA1c greater than 7%
  • Informed Consent

Exclusion Criteria:

  • Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
  • Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699179

Locations
Former Serbia and Montenegro
Belgrade, Former Serbia and Montenegro, 11 070
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Marija Vujasin, MD Novo Nordisk Pharma d.o.o
Study Director: Predrag Radosevic, PhD sci. pharm Novo Nordisk Pharma d.o.o
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00699179     History of Changes
Other Study ID Numbers: BIASP-3557
Study First Received: June 13, 2008
Last Updated: August 12, 2014
Health Authority: Serbia: Medicines and Medical Devices Agency of Serbia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014