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 profilesIncidence 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
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