Diabetes Mellitus, Type 2 Clinical Trial
— PRESENTOfficial 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
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.
| Status | Completed |
| Enrollment | 33010 |
| Est. completion date | December 2006 |
| Est. primary completion date | December 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Novo Nordisk Investigational Site | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Korea, Republic of,
Gao Y, Guo XH, Vaz JA; PRESENT Study Group.. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study. Diabetes Obes Metab. 2009 Jan;11(1):33-40. doi: 10.1111/j. — View Citation
Güler S, Sharma SK, Almustafa M, Kim CH, Azar S, Danciulescu R, Shestakova M, Khutsoane D, Bech OM. Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results. Arch Drug In — View Citation
Jang HC, Guler S, Shestakova M; PRESENT Study Group.. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. — View Citation
Khutsoane D, Sharma SK, Almustafa M, Jang HC, Azar ST, Danciulescu R, Shestakova M, Ayad NM, Guler S, Bech OM; PRESENT Study Group.. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice se — View Citation
Shestakova M, Sharma SK, Almustafa M, Min KW, Ayad N, Azar ST, Danciulescu R, Khutsoane D, Guler S. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT s — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in HbA1c (glycosylated haemoglobin) | No | ||
| Secondary | Change in post prandial glucose (PPG) | No | ||
| Secondary | Change in fasting glucose (FG) | No | ||
| Secondary | Difference in prandial glucose increment (PGI) | No | ||
| Secondary | Incidence of hypoglycaemic episodes | No | ||
| Secondary | Adverse drug reactions (ADR) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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