Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00097279
NCT00097279CompletedPhase 3

A Multicenter, Open-Label, Randomised Trial to Compare the Efficacy and Safety of NovoLog Mix 70/30 BID in Combination With Metformin and Pioglitazone to Metformin and Pioglitazone Alone in Insulin Naïve Subjects With Type 2 Diabetes

Novo Nordisk A/S74 sites in 1 country230 target enrollmentStarted: August 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
230
Locations
74
Primary Endpoint
HbA1c
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects with type 2 diabetes mellitus

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

HbA1c

Time Frame: After 24 weeks

Secondary Outcomes

  • Safety variables
  • Other glycemic variables
  • 8-point plasma glucose profiles

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (74)

Loading locations...

Similar Trials

Completed
Phase 4
NovoLog Observation Trial in Subjects With Type 1 and Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2Diabetes Mellitus, Type 1
NCT00095446Novo Nordisk A/S513
Completed
Phase 4
Novofine Autocover Safety Needle Versus BD Safety GlideHealthcare ProfessionalsDelivery SystemsDiabetes
NCT00121355Novo Nordisk A/S83
Completed
Phase 3
Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in DiabeticsDelivery SystemsDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
NCT00773279Novo Nordisk A/S242
Completed
Phase 4
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major SurgeryCongenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors
NCT01561391Novo Nordisk A/S36
Terminated
Phase 2
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell TransplantationAcquired Bleeding DisorderBleeding During/Following Surgery
NCT01564563Novo Nordisk A/S11