MedTrace Logo

Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)

NCT01212913 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2013-07-08

No results posted yet for this study

Summary

Primary Objective:

To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen.

Secondary Objective:

To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

INSULIN GLARGINE

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily

DRUG

INSULIN GLULISINE

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily

DRUG

Insulin aspart

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

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 NCT01212913 on ClinicalTrials.gov