Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

Condition or disease	Intervention/treatment
Diabetes; Diabetes Mellitus, Type 2	Drug: insulin detemir; Drug: biphasic insulin aspart 30

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	3421 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia
Study Start Date :	May 2009
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	October 2010

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Insulin detemir	Drug: insulin detemir; Safety and effectiveness data collection in connection with the use of the drug.; Other Names: NN304; Levemir®
Biphasic insulin aspart 30	Drug: biphasic insulin aspart 30; Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Incidence of serious adverse drug reactions (SADRs) [ Time Frame: after 26 weeks ]

Secondary Outcome Measures :

1. Number of all minor hypoglycaemic events [ Time Frame: during 4 weeks preceding each visit ]
2. Number of all major hypoglycaemic events [ Time Frame: during 13 weeks preceding each visit ]
3. HbA1c [ Time Frame: after 26 weeks ]
4. Percentage of subjects to reach HbA1c below 7.0% [ Time Frame: after 13 weeks and 26 weeks ]
5. The effect on glycaemic control as measured by FPG (fasting plasma glucose) [ Time Frame: after 13 weeks and 26 weeks ]
6. The effect on glycamic control as measured by PG profile [ Time Frame: after 13 weeks and 26 weeks ]
7. Change in body weight [ Time Frame: after 13 weeks and 26 weeks ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients from speciality practice settings who have been deemed appropriate to receive biphasic insulin aspart 30 or insulin detemir as new treatment and as part of routine out-patient care by the prescribing physician.

Criteria

Inclusion Criteria:

• After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

• Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
• Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
• Subjects who were previously enrolled in this study
• Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, MK-1000

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Clinical Trials at Novo Nordisk 

Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00842894 History of Changes
Other Study ID Numbers:	NN304-3716
First Posted:	February 12, 2009
Last Update Posted:	August 15, 2014
Last Verified:	November 2012

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin, Globin Zinc; Insulin degludec, insulin aspart drug combination; Insulin aspart, insulin aspart protamine drug combination 30:70	Insulin; Insulin Aspart; Insulin, Long-Acting; Insulin Detemir; Biphasic Insulins; Insulin, Isophane; Hypoglycemic Agents; Physiological Effects of Drugs