Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 463
Not provided
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 826-130
🇬🇧Bristol, United Kingdom
Investigational Site Number 826-149
🇬🇧Barnsley, United Kingdom
Investigational Site Number 826-136
🇬🇧Bradford, United Kingdom
Investigational Site Number 209
🇦🇺Milton, Australia
Investigational Site Number 826-106
🇬🇧Bournemouth, United Kingdom
Investigational Site Number 826-141
🇬🇧Cheadle, United Kingdom
Investigational Site Number 826-127
🇬🇧Glasgow, United Kingdom
Investigational Site Number 826-164
🇬🇧Hereford, United Kingdom
Investigational Site Number 826-122
🇬🇧Livingston, United Kingdom
Investigational Site Number 826-116
🇬🇧Salford, United Kingdom
Investigational Site Number 826-166
🇬🇧London, United Kingdom
Investigational Site Number 826-110
🇬🇧Llantrisant, United Kingdom
Investigational Site Number 826-137
🇬🇧Manchester, United Kingdom
Investigational Site Number 204
🇦🇺Campbelltown, Australia
Investigational Site Number 205
🇦🇺Campbelltown, Australia
Investigational Site Number 210
🇦🇺Daw Park, Australia
Investigational Site Number 214
🇦🇺Douglas, Australia
Investigational Site Number 201
🇦🇺Caulfield, 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
Investigational Site Number 213
🇦🇺Nowra, Australia
Investigational Site Number 202
🇦🇺Parkville, Australia
Investigational Site Number 208
🇦🇺Southport, Australia
Investigational Site Number 826-109
🇬🇧Aberdeen, United Kingdom
Investigational Site Number 826-126
🇬🇧High Wycombe, United Kingdom
Investigational Site Number 826-102
🇬🇧Hull, United Kingdom
Investigational Site Number 826-140
🇬🇧Newcastle upon Tyne, United Kingdom
Investigational Site Number 826-143
🇬🇧Scunthorpe, United Kingdom
Investigational Site Number 826-104
🇬🇧Sheffield, United Kingdom
Investigational Site Number 826-118
🇬🇧Ashton-under-Lyne, United Kingdom
Investigational Site Number 826-157
🇬🇧Ayr, United Kingdom
Investigational Site Number 826-135
🇬🇧Bath, United Kingdom
Investigational Site Number 826-124
🇬🇧Birmingham, United Kingdom
Investigational Site Number 826-150
🇬🇧Birmingham, United Kingdom
Investigational Site Number 826-114
🇬🇧Bury St Edmunds, United Kingdom
Investigational Site Number 826-132
🇬🇧Carmarthen, United Kingdom
Investigational Site Number 826-112
🇬🇧Chesterfield, United Kingdom
Investigational Site Number 826-147
🇬🇧Chester, United Kingdom
Investigational Site Number 826-152
🇬🇧Chichester, United Kingdom
Investigational Site Number 826-159
🇬🇧Cleveleys, United Kingdom
Investigational Site Number 826-119
🇬🇧Cornwall, United Kingdom
Investigational Site Number 826-113
🇬🇧Colchester, United Kingdom
Investigational Site Number 826-162
🇬🇧Crawley, United Kingdom
Investigational Site Number 826-145
🇬🇧Dafen, United Kingdom
Investigational Site Number 826-165
🇬🇧Dumfries, United Kingdom
Investigational Site Number 826-167
🇬🇧Durham, United Kingdom
Investigational Site Number 826-173
🇬🇧East Kilbride, United Kingdom
Investigational Site Number 826-105
🇬🇧Edinburgh, United Kingdom
Investigational Site Number 826-115
🇬🇧Exeter, United Kingdom
Investigational Site Number 826-160
🇬🇧Fleetwood, United Kingdom
Investigational Site Number 826-107
🇬🇧Gateshead, United Kingdom
Investigational Site Number 826-174
🇬🇧Haddington, United Kingdom
Investigational Site Number 826-120
🇬🇧Ipswich, United Kingdom
Investigational Site Number 826-163
🇬🇧Kirkcaldy, United Kingdom
Investigational Site Number 826-161
🇬🇧Lancaster, United Kingdom
Investigational Site Number 826-101
🇬🇧Liverpool, United Kingdom
Investigational Site Number 826-108
🇬🇧Liverpool, United Kingdom
Investigational Site Number 826-142
🇬🇧London, United Kingdom
Investigational Site Number 826-123
🇬🇧London, United Kingdom
Investigational Site Number 826-156
🇬🇧Mortimer, United Kingdom
Investigational Site Number 826-138
🇬🇧Newport, United Kingdom
Investigational Site Number 826-133
🇬🇧Nottingham, United Kingdom
Investigational Site Number 826-121
🇬🇧Nuneaton, United Kingdom
Investigational Site Number 826-129
🇬🇧Plymouth, United Kingdom
Investigational Site Number 826-103
🇬🇧St Helens, United Kingdom
Investigational Site Number 826-139
🇬🇧St Leonards on Sea, United Kingdom
Investigational Site Number 826-111
🇬🇧Stevenage, United Kingdom
Investigational Site Number 826-131
🇬🇧Stirling, United Kingdom
Investigational Site Number 826-146
🇬🇧Sunderland, United Kingdom
Investigational Site Number 826-128
🇬🇧Westbury, United Kingdom
Investigational Site Number 826-117
🇬🇧York, United Kingdom