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Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients

NCT00965549 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2013-01-08

No results posted yet for this study

Summary

The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes.

The secondary objective are:

* To compare the proportion of patients in each treatment group reaching HbA1c target (\< 7%) at the end of the treatment period
* To compare the rates of hypoglycaemia (total, severe, nocturnal)
* To compare the change in body weight from visit 10 to visit 24
* To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24

* Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c)
* Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire
* Insulin Treatment Satisfaction Questionnaire (ITSQ)
* EuroQoL 5 Dimensions (EQ5D) questionnaire
* To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

INSULIN GLARGINE (HOE901)

LANTUS®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)

DRUG

Insulin aspart

NovoMix® 30: Suspension for injection. 100U/mL in a prefilled pen (FlexPen®)

DRUG

Insulin Glulisine

APIDRA®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)

Sponsors & Collaborators

Principal Investigators

  • Christine van Schalkwyk, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Australia
  • United Kingdom

Study Locations

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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 NCT00965549 on ClinicalTrials.gov