Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes (PRESENT)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01536600
First received: February 16, 2012
Last updated: April 11, 2012
Last verified: April 2012
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Purpose
This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.
| Condition | Intervention |
|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: biphasic insulin aspart 30 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Change in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in post prandial glucose (PPG) [ Designated as safety issue: No ]
- Change in fasting glucose (FG) [ Designated as safety issue: No ]
- Difference in prandial glucose increment (PGI) [ Designated as safety issue: No ]
- Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
- Adverse drug reactions (ADR) [ Designated as safety issue: No ]
| Enrollment: | 33010 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| BIAsp 30 users |
Drug: biphasic insulin aspart 30
The insulin dose and regimen was individualised at the physician's discretion
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with type 2 diabetes who were not adequately controlled on their current therapy and who were prescribed biphasic insulin aspart 30 (NovoMix® 30)
Criteria
Inclusion Criteria:
- Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536600
Locations
| China, Beijing | |
| Beijing, Beijing, China, 100004 | |
| India | |
| Bangalore, India, 560001 | |
| Iraq | |
| Amman, Iraq, 11844 | |
| Jordan | |
| Amman, Jordan, 11844 | |
| Korea, Republic of | |
| Seoul, Korea, Republic of, 137-920 | |
| Lebanon | |
| Amman, Lebanon, 11844 | |
| Russian Federation | |
| Moscow, Russian Federation, 119330 | |
| Saudi Arabia | |
| Riyadh, Saudi Arabia, 3542 | |
| South Africa | |
| Sandton, South Africa, 2146 | |
| Sri Lanka | |
| Bangalore, Sri Lanka, 560001 | |
| Turkey | |
| Istanbul, Turkey, 34335 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Corporate Vice President for diabetes and devices | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01536600 History of Changes |
| Other Study ID Numbers: | BIASP-1880 |
| Study First Received: | February 16, 2012 |
| Last Updated: | April 11, 2012 |
| Health Authority: | China: Ministry of Health India: Ministry of Health and Family Wellfare Iraq: Ministry of Health Lebanon: Ministry of Public Health Russia: Ministry of Health of the Russian Federation Saudi Arabia: Ministry of Health South Africa: Medicines Control Council South Korea: Institutional Review Board Sri Lanka: Ministry of Health Turkey: Ministry of Health Drug and Pharmaceutical Department Jordan: Ministry of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Insulin Hypoglycemic Agents Insulin, NPH Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013