Clinical trial NCT00965549: Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients
Official title: Comparison of a Basal Plus One Insulin Regimen (Insulin Glargine/Insulin Glulisine) With a Biphasic Insulin Regimen (Insulin Aspart/Insulin Aspart Protamine 30/70) in Type 2 Diabetes Patients Following Basal Insulin Optimisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* Type 2 diabetes mellitus
* Patients being treated with Lantus once daily, Levemir once or twice daily or NPH insulin once or twice daily as a single insulin for at least three months 10.0% \> or = HbA1c \> or = 7.5%
* BMI \< or = 40 kg/m²
* If patients are taking oral antidiabetics (OADs), the dose must be stable for at least 1 month
* Ability and willingness to perform blood glucose monitoring using a blood glucose meter and ability and willingness to use a patient diary
* Provision of written informed obtained prior to enrollment in the study

Exclusion criteria:

* Type 1 diabetes mellitus
* Current or previous treatment with an insulin other than basal insulin (biphasic insulin, short acting insulin, rapid-acting insulin analogue)
* Treatment with GLP-1 receptor agonists or with DPPIV inhibitors in the 3 months before screening
* Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before screening or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus exam performed in the 2 years prior to screening)
* Unable or unwilling to enter either of the treatment arms
* Women who are pregnant or lactating (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
* History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
* Treatment with systemic corticosteroids in the 3 months prior to study entry
* Treatment with any investigational product in the 2 months prior to study entry
* Current treatment with any non-selective beta-blockers
* Likelihood of requiring treatment during the study period with drugs not permitted by this clinical protocol
* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
* Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at screening
* Impaired renal function as shown by serum creatinine \>135 µmol/l in men and \> 110 µmol/l in women at screening
* History of drug or alcohol abuse
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patient unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study
* Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Glycosylated Haemoglobin (HbA1c)
timeFrame: At week 7 and week 32
Secondary outcomes:
measure: Weight
timeFrame: At week 8 and week 32
measure: 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)
timeFrame: Week 8 and week 32
measure: Hypoglycaemia (total, severe and nocturnal)
timeFrame: At week 0 and week 32
Other outcomes:
Locations:
city: Campbelltown
country: Australia
facility: Investigational Site Number 204
city: Campbelltown
country: Australia
facility: Investigational Site Number 205
city: Caulfield
country: Australia
facility: Investigational Site Number 201
city: Daw Park
country: Australia
facility: Investigational Site Number 210
city: Douglas
country: Australia
facility: Investigational Site Number 214
city: Heidelberg
country: Australia
facility: Investigational Site Number 203
city: Herston
country: Australia
facility: Investigational Site Number 206
city: Maroubra
country: Australia
facility: Investigational Site Number 211
city: Meadowbrook
country: Australia
facility: Investigational Site Number 207
city: Melbourne
country: Australia
facility: Investigational Site Number 212
city: Milton
country: Australia
facility: Investigational Site Number 209
city: Nowra
country: Australia
facility: Investigational Site Number 213
city: Parkville
country: Australia
facility: Investigational Site Number 202
city: Southport
country: Australia
facility: Investigational Site Number 208
city: Aberdeen
country: United Kingdom
facility: Investigational Site Number 826-109
city: Ashton-under-Lyne
country: United Kingdom
facility: Investigational Site Number 826-118
city: Ayr
country: United Kingdom
facility: Investigational Site Number 826-157
city: Barnsley
country: United Kingdom
facility: Investigational Site Number 826-149
city: Bath
country: United Kingdom
facility: Investigational Site Number 826-135
city: Birmingham
country: United Kingdom
facility: Investigational Site Number 826-124
city: Birmingham
country: United Kingdom
facility: Investigational Site Number 826-150
city: Bournemouth
country: United Kingdom
facility: Investigational Site Number 826-106
city: Bradford
country: United Kingdom
facility: Investigational Site Number 826-136
city: Bristol
country: United Kingdom
facility: Investigational Site Number 826-130
city: Bury St Edmunds
country: United Kingdom
facility: Investigational Site Number 826-114
city: Carmarthen
country: United Kingdom
facility: Investigational Site Number 826-132
city: Cheadle
country: United Kingdom
facility: Investigational Site Number 826-141
city: Chesterfield
country: United Kingdom
facility: Investigational Site Number 826-112
city: Chester
country: United Kingdom
facility: Investigational Site Number 826-147
city: Chichester
country: United Kingdom
facility: Investigational Site Number 826-152
city: Cleveleys
country: United Kingdom
facility: Investigational Site Number 826-159
city: Colchester
country: United Kingdom
facility: Investigational Site Number 826-113
city: Cornwall
country: United Kingdom
facility: Investigational Site Number 826-119
city: Crawley
country: United Kingdom
facility: Investigational Site Number 826-162
city: Dafen
country: United Kingdom
facility: Investigational Site Number 826-145
city: Dumfries
country: United Kingdom
facility: Investigational Site Number 826-165
city: Durham
country: United Kingdom
facility: Investigational Site Number 826-167
city: East Kilbride
country: United Kingdom
facility: Investigational Site Number 826-173
city: Edinburgh
country: United Kingdom
facility: Investigational Site Number 826-105
city: Exeter
country: United Kingdom
facility: Investigational Site Number 826-115
city: Fleetwood
country: United Kingdom
facility: Investigational Site Number 826-160
city: Gateshead
country: United Kingdom
facility: Investigational Site Number 826-107
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 826-127
city: Haddington
country: United Kingdom
facility: Investigational Site Number 826-174
city: Hereford
country: United Kingdom
facility: Investigational Site Number 826-164
city: High Wycombe
country: United Kingdom
facility: Investigational Site Number 826-126
city: Hull
country: United Kingdom
facility: Investigational Site Number 826-102
city: Ipswich
country: United Kingdom
facility: Investigational Site Number 826-120
city: Kirkcaldy
country: United Kingdom
facility: Investigational Site Number 826-163
city: Lancaster
country: United Kingdom
facility: Investigational Site Number 826-161
city: Liverpool
country: United Kingdom
facility: Investigational Site Number 826-101
city: Liverpool
country: United Kingdom
facility: Investigational Site Number 826-108
city: Livingston
country: United Kingdom
facility: Investigational Site Number 826-122
city: Llantrisant
country: United Kingdom
facility: Investigational Site Number 826-110
city: London
country: United Kingdom
facility: Investigational Site Number 826-142
city: London
country: United Kingdom
facility: Investigational Site Number 826-123
city: London
country: United Kingdom
facility: Investigational Site Number 826-166
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826-137
city: Mortimer
country: United Kingdom
facility: Investigational Site Number 826-156
city: Newcastle upon Tyne
country: United Kingdom
facility: Investigational Site Number 826-140
city: Newport
country: United Kingdom
facility: Investigational Site Number 826-138
city: Nottingham
country: United Kingdom
facility: Investigational Site Number 826-133
city: Nuneaton
country: United Kingdom
facility: Investigational Site Number 826-121
city: Plymouth
country: United Kingdom
facility: Investigational Site Number 826-129
city: Salford
country: United Kingdom
facility: Investigational Site Number 826-116
city: Scunthorpe
country: United Kingdom
facility: Investigational Site Number 826-143
city: Sheffield
country: United Kingdom
facility: Investigational Site Number 826-104
city: St Helens
country: United Kingdom
facility: Investigational Site Number 826-103
city: St Leonards on Sea
country: United Kingdom
facility: Investigational Site Number 826-139
city: Stevenage
country: United Kingdom
facility: Investigational Site Number 826-111
city: Stirling
country: United Kingdom
facility: Investigational Site Number 826-131
city: Sunderland
country: United Kingdom
facility: Investigational Site Number 826-146
city: Westbury
country: United Kingdom
facility: Investigational Site Number 826-128
city: York
country: United Kingdom
facility: Investigational Site Number 826-117
Study officials:
affiliation: Sanofi
name: Christine van Schalkwyk, MD
role: STUDY_DIRECTOR
References: