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CompletedNCT01536600PRESENTUpdated Jan 6, 2017

Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes

An observational study in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2017-01-06.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
33,010
Sex
All
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Study summary

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.

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Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 33,010 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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)

Eligibility criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
33,010 participants (actual)
Patient registry
No

Groups and cohorts

  • BIAsp 30 users

    Drug: biphasic insulin aspart 30

Interventions

  • Drugbiphasic insulin aspart 30

    The insulin dose and regimen was individualised at the physician's discretion

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What researchers measure

Primary outcomes

  1. Change in HbA1c (glycosylated haemoglobin)

Secondary outcomes

  1. Change in post prandial glucose (PPG)

  2. Change in fasting glucose (FG)

  3. Difference in prandial glucose increment (PGI)

  4. Incidence of hypoglycaemic episodes

  5. Adverse drug reactions (ADR)

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Study locations

1 site
  • Novo Nordisk Investigational Site
    Seoul, 137-920, Korea, Republic of
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References and documents

Publications

  • Guler 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 Inf. 2009 Jun;2(2):23-33. doi: 10.1111/j.1753-5174.2008.00015.x. PubMed 19684847 ↗
  • 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 setting: experience from the PRESENT study. Diabetes Obes Metab. 2008 Mar;10(3):212-22. doi: 10.1111/j.1463-1326.2007.00826.x. PubMed 18269636 ↗
  • 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 study. Curr Med Res Opin. 2007 Dec;23(12):3209-14. doi: 10.1185/030079907X253636. PubMed 18005503 ↗
  • 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.1463-1326.2008.00904.x. Epub 2008 May 20. Erratum In: Diabetes Obes Metab. 2009 Jan;11(1):77. PubMed 18494806 ↗
  • 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. Int J Clin Pract. 2008 Jul;62(7):1013-8. doi: 10.1111/j.1742-1241.2008.01792.x. Epub 2008 May 9. PubMed 18479365 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01536600
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 22, 2012
Start date
Sep 2004
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Jan 6, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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