Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00842894 |
Recruitment Status
:
Completed
First Posted
: February 12, 2009
Last Update Posted
: August 15, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Diabetes Diabetes Mellitus, Type 2 | Drug: insulin detemir Drug: biphasic insulin aspart 30 |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Insulin detemir |
Drug: insulin detemir
Safety and effectiveness data collection in connection with the use of the drug.
Other Names:
|
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.
|
- Incidence of serious adverse drug reactions (SADRs) [ Time Frame: after 26 weeks ]
- Number of all minor hypoglycaemic events [ Time Frame: during 4 weeks preceding each visit ]
- Number of all major hypoglycaemic events [ Time Frame: during 13 weeks preceding each visit ]
- HbA1c [ Time Frame: after 26 weeks ]
- Percentage of subjects to reach HbA1c below 7.0% [ Time Frame: after 13 weeks and 26 weeks ]
- The effect on glycaemic control as measured by FPG (fasting plasma glucose) [ Time Frame: after 13 weeks and 26 weeks ]
- The effect on glycamic control as measured by PG profile [ Time Frame: after 13 weeks and 26 weeks ]
- Change in body weight [ Time Frame: after 13 weeks and 26 weeks ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842894
Macedonia, The Former Yugoslav Republic of | |
Skopje, Macedonia, The Former Yugoslav Republic of, MK-1000 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00842894 History of Changes |
Other Study ID Numbers: |
NN304-3716 |
First Posted: | February 12, 2009 Key Record Dates |
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 |