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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00965549




Registration number
NCT00965549
Ethics application status
Date submitted
24/08/2009
Date registered
25/08/2009
Date last updated
8/01/2013

Titles & IDs
Public title
Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients
Scientific 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
Secondary ID [1] 0 0
2008-007026-19(EudraCT)
Secondary ID [2] 0 0
LANTU_L_04211
Universal Trial Number (UTN)
Trial acronym
LanScape
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INSULIN GLARGINE (HOE901)
Treatment: Drugs - Insulin aspart
Treatment: Drugs - Insulin Glulisine

Experimental: Lantus + Apidra basal plus one - 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

Active comparator: NovoMix 30 Biphasic - 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)


Treatment: Drugs: INSULIN GLARGINE (HOE901)
LANTUS®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)

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

Treatment: Drugs: Insulin Glulisine
APIDRA®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycosylated Haemoglobin (HbA1c)
Timepoint [1] 0 0
At week 7 and week 32
Secondary outcome [1] 0 0
Weight
Timepoint [1] 0 0
At week 8 and week 32
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Week 8 and week 32
Secondary outcome [3] 0 0
Hypoglycaemia (total, severe and nocturnal)
Timepoint [3] 0 0
At week 0 and week 32

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
463
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 204 - Campbelltown
Recruitment hospital [2] 0 0
Investigational Site Number 205 - Campbelltown
Recruitment hospital [3] 0 0
Investigational Site Number 201 - Caulfield
Recruitment hospital [4] 0 0
Investigational Site Number 210 - Daw Park
Recruitment hospital [5] 0 0
Investigational Site Number 214 - Douglas
Recruitment hospital [6] 0 0
Investigational Site Number 203 - Heidelberg
Recruitment hospital [7] 0 0
Investigational Site Number 206 - Herston
Recruitment hospital [8] 0 0
Investigational Site Number 211 - Maroubra
Recruitment hospital [9] 0 0
Investigational Site Number 207 - Meadowbrook
Recruitment hospital [10] 0 0
Investigational Site Number 212 - Melbourne
Recruitment hospital [11] 0 0
Investigational Site Number 209 - Milton
Recruitment hospital [12] 0 0
Investigational Site Number 213 - Nowra
Recruitment hospital [13] 0 0
Investigational Site Number 202 - Parkville
Recruitment hospital [14] 0 0
Investigational Site Number 208 - Southport
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
3162 - Caulfield
Recruitment postcode(s) [3] 0 0
5041 - Daw Park
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment postcode(s) [6] 0 0
4006 - Herston
Recruitment postcode(s) [7] 0 0
2035 - Maroubra
Recruitment postcode(s) [8] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [9] 0 0
3065 - Melbourne
Recruitment postcode(s) [10] 0 0
4064 - Milton
Recruitment postcode(s) [11] 0 0
2541 - Nowra
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Aberdeen
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United Kingdom
State/province [2] 0 0
Ashton-under-Lyne
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Ayr
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United Kingdom
State/province [4] 0 0
Barnsley
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Bath
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United Kingdom
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Birmingham
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United Kingdom
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Bournemouth
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Bradford
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United Kingdom
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Bristol
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United Kingdom
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Bury St Edmunds
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United Kingdom
State/province [11] 0 0
Carmarthen
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United Kingdom
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Cheadle
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United Kingdom
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Chesterfield
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United Kingdom
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Chester
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United Kingdom
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Chichester
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United Kingdom
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Cleveleys
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United Kingdom
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Colchester
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Cornwall
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Crawley
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Dafen
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Dumfries
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Durham
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United Kingdom
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East Kilbride
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United Kingdom
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Edinburgh
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United Kingdom
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Exeter
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Fleetwood
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Gateshead
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Glasgow
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Haddington
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Hereford
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High Wycombe
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United Kingdom
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Hull
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United Kingdom
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Ipswich
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United Kingdom
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Kirkcaldy
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Lancaster
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Liverpool
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Livingston
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Llantrisant
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London
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Manchester
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Mortimer
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Newcastle upon Tyne
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Newport
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Nottingham
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Nuneaton
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Plymouth
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Salford
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Scunthorpe
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Sheffield
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St Helens
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St Leonards on Sea
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Stevenage
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Stirling
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Sunderland
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Westbury
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United Kingdom
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT00965549
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christine van Schalkwyk, MD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00965549