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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: INSULIN GLARGINE (HOE901); Drug: Insulin aspart; Drug: Insulin Glulisine

• Registration Number: NCT00965549
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lantus + Apidra basal plus one	Insulin Glulisine	Before randomization (common with arm 2): A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy. 8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued. After randomization: 24 weeks of treatment period: Insulin (Lantus®) + metformin (if applicable) + a single injection of insulin glulisine (Apidra®), the latter administered at the patients largest meal of the day
Lantus + Apidra basal plus one	INSULIN GLARGINE (HOE901)	Before randomization (common with arm 2): A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy. 8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued. After randomization: 24 weeks of treatment period: Insulin (Lantus®) + metformin (if applicable) + a single injection of insulin glulisine (Apidra®), the latter administered at the patients largest meal of the day
NovoMix 30 Biphasic	Insulin aspart	Before randomization (common with arm 1): A 1 to 2 weeks of screening period: patients will continue on their current insulin and oral antidiabetic drug (OAD) therapy. 8 weeks of run-in period: patients will switch their treatment for insulin glargine (one daily injection at bedtime) and all OADs (with the exception of metformin) will be discontinued. After randomization: 24 weeks of treatment period: Insulin aspart/ insulin protamine crystallised insulin aspart (NovoMix® 30) + metformin (if applicable)

Primary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin (HbA1c)	At week 7 and week 32

Secondary Outcome Measures

Name	Time	Method
Hypoglycaemia (total, severe and nocturnal)	At week 0 and week 32
Diabetes specific quality of life measured using ADDQoL (Audit of Diabetes-Dependent Quality of Life questionnaire) and other patient reported outcomes measured using EQ5D (EuroQoL 5 Dimensions questionnaire)	Week 8 and week 32
Weight	At week 8 and week 32

Trial Locations

Locations (74)

Investigational Site Number 204; 🇦🇺 Campbelltown, Australia

Investigational Site Number 205; 🇦🇺 Campbelltown, Australia

Investigational Site Number 201; 🇦🇺 Caulfield, Australia

Investigational Site Number 210; 🇦🇺 Daw Park, Australia

Investigational Site Number 214; 🇦🇺 Douglas, Australia

Investigational Site Number 203; 🇦🇺 Heidelberg, Australia

Investigational Site Number 206; 🇦🇺 Herston, Australia

Investigational Site Number 211; 🇦🇺 Maroubra, Australia

Investigational Site Number 207; 🇦🇺 Meadowbrook, Australia

Investigational Site Number 212; 🇦🇺 Melbourne, Australia

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