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Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

NCT00469092 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2017-02-23

Study results available
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Summary

This trial is conducted in Africa, Asia, Europe, Oceania and South America.

This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Conditions

Interventions

DRUG

biphasic insulin aspart

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

DRUG

insulin glargine

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

DRUG

metformin

Tablets, 2550 mcg. Administered once daily.

DRUG

glimepiride

Tablets 2 mg. 4, 6 or 8 mg administered once daily.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Argentina
  • Austria
  • Czechia
  • France
  • India
  • Malaysia
  • Mexico
  • Netherlands
  • Philippines
  • Poland
  • Romania
  • Serbia and Montenegro
  • South Africa
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00469092 on ClinicalTrials.gov