Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00842894
First received: February 11, 2009
Last updated: August 13, 2014
Last verified: November 2012
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Purpose
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 | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin detemir Drug: biphasic insulin aspart 30 |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Incidence of serious adverse drug reactions (SADRs) [ Time Frame: after 26 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of all minor hypoglycaemic events [ Time Frame: during 4 weeks preceding each visit ] [ Designated as safety issue: Yes ]
- Number of all major hypoglycaemic events [ Time Frame: during 13 weeks preceding each visit ] [ Designated as safety issue: Yes ]
- HbA1c [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]
- Percentage of subjects to reach HbA1c below 7.0% [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
- The effect on glycaemic control as measured by FPG (fasting plasma glucose) [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
- The effect on glycamic control as measured by PG profile [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
- Change in body weight [ Time Frame: after 13 weeks and 26 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 3421 |
| Study Start Date: | May 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| 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
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: NCT00842894
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842894
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
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00842894 History of Changes |
| Other Study ID Numbers: | NN304-3716 |
| Study First Received: | February 11, 2009 |
| Last Updated: | August 13, 2014 |
| Health Authority: | Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health |
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 Biphasic Insulins Insulin Detemir Insulin, Isophane Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016