Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs

NCT00537277 | Completed Phase 4 Results

• 1 other identifier: BIASP-1849
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%

  week 48

Secondary Outcomes (5)

• Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%

  week 48

• Number of Hypoglycaemic Episodes

  weeks 0-48

• Number of Diurnal Hypoglycaemic Episodes

  weeks 0-48

• Number of Nocturnal Hypoglycaemic Episodes

  weeks 0-48

• Number of Treatment Emergent Serious Adverse Events (SAEs)

  weeks 0-48

Study Arms (1)

BIAsp 30

EXPERIMENTAL

Biphasic insulin aspart 30 administered once daily for 16 weeks. If HbA1c is higher than 7.0 % after 16 weeks of treatment, dose is increased to twice daily for another 16 weeks. If HbA1c is higher than 7.0 % after 32 weeks of treatment, dose is increased to three times daily until week 48 (end of trial).

Drug: biphasic insulin aspart

Interventions

biphasic insulin aspart DRUG

Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)

Also known as: BIasp, NovoLog Mix 70/30, NovoMix 30

BIAsp 30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus for more than 12 months
• HbA1c: 7.5 - 11.0%
• An antidiabetic regimen that has been stable for at least 3 months prior to screening
• An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin
• OADs dosed at 50% or more of the maximum recommended dose

You may not qualify if:

• Use of any insulin preparations other than NPH or glargine within the past 6 months
• Use of more than 60 units of insulin per day
• Morning time insulin administration
• Use of more than one insulin dose daily

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Istanbul, 343662, Turkey (Türkiye)

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 8, 2014
• Results First Posted: August 17, 2010

Record last verified: 2014-11

Locations

TU (1)