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Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen� in Insulin Naive Subjects With Type 2 Diabetes

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2

Intervention: biphasic insulin aspart (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Marija Vujasin, MD, Study Director, Affiliation: Novo Nordisk Pharma doo

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).

Clinical Details

Official title: Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: HbA1c

Secondary outcome:

Blood glucose profiles

Incidence of hypoglycaemic episodes

Incidence of adverse events

Eligibility

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Insulin naive diabetes

- Current treatment with OHA, secondary failure

- Body mass index (BMI) below 40 kg/m2

- HbA1c over 8. 5%

- Willing and able to start with insulin therapy and to perform self-blood glucose

monitoring Exclusion Criteria:

- History of drug or alcohol abuse

- Receipt of the investigational drug within the last month prior to this trial

- Known or suspected allergy to trial products or related products

- Severe uncontrolled hypertension

- Any disease or condition, which the Investigator feels, would interfere with the

trial

Locations and Contacts

Belgrade 11000, Former Serbia and Montenegro
Additional Information

Clinical Trials at Novo Nordisk

Starting date: March 2004
Last updated: June 15, 2012

Page last updated: August 23, 2015

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