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

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ClinicalTrials.gov Identifier: NCT00965549
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: INSULIN GLARGINE (HOE901) Drug: Insulin aspart Drug: Insulin Glulisine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 463 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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

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)

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




Primary Outcome Measures :
  1. Glycosylated Haemoglobin (HbA1c) [ Time Frame: At week 7 and week 32 ]

Secondary Outcome Measures :
  1. Weight [ Time Frame: At week 8 and week 32 ]
  2. 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) [ Time Frame: Week 8 and week 32 ]
  3. Hypoglycaemia (total, severe and nocturnal) [ Time Frame: At week 0 and week 32 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965549


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Locations
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Australia
Investigational Site Number 204
Campbelltown, Australia, 2560
Investigational Site Number 205
Campbelltown, Australia, 2560
Investigational Site Number 201
Caulfield, Australia, 3162
Investigational Site Number 210
Daw Park, Australia, 5041
Investigational Site Number 214
Douglas, Australia, 4814
Investigational Site Number 203
Heidelberg, Australia, 3081
Investigational Site Number 206
Herston, Australia, 4006
Investigational Site Number 211
Maroubra, Australia, 2035
Investigational Site Number 207
Meadowbrook, Australia, 4131
Investigational Site Number 212
Melbourne, Australia, 3065
Investigational Site Number 209
Milton, Australia, 4064
Investigational Site Number 213
Nowra, Australia, 2541
Investigational Site Number 202
Parkville, Australia, 3050
Investigational Site Number 208
Southport, Australia, 4215
United Kingdom
Investigational Site Number 826-109
Aberdeen, United Kingdom, AB251LD
Investigational Site Number 826-118
Ashton-under-Lyne, United Kingdom, OL69RW
Investigational Site Number 826-157
Ayr, United Kingdom, KA66DX
Investigational Site Number 826-149
Barnsley, United Kingdom, S752EP
Investigational Site Number 826-135
Bath, United Kingdom, BA13NG
Investigational Site Number 826-124
Birmingham, United Kingdom, B187QH
Investigational Site Number 826-150
Birmingham, United Kingdom, B95SS
Investigational Site Number 826-106
Bournemouth, United Kingdom, BH77DW
Investigational Site Number 826-136
Bradford, United Kingdom, BD96RJ
Investigational Site Number 826-130
Bristol, United Kingdom, BS105NB
Investigational Site Number 826-114
Bury St Edmunds, United Kingdom, IP332QZ
Investigational Site Number 826-132
Carmarthen, United Kingdom, SA312AF
Investigational Site Number 826-141
Cheadle, United Kingdom, SK86LU
Investigational Site Number 826-112
Chesterfield, United Kingdom, S404TF
Investigational Site Number 826-147
Chester, United Kingdom, CH21UL
Investigational Site Number 826-152
Chichester, United Kingdom, PO196SE
Investigational Site Number 826-159
Cleveleys, United Kingdom, FY53LF
Investigational Site Number 826-113
Colchester, United Kingdom, CO45JL
Investigational Site Number 826-119
Cornwall, United Kingdom, TR13LJ
Investigational Site Number 826-162
Crawley, United Kingdom, RH107DX
Investigational Site Number 826-145
Dafen, United Kingdom, SA14 8QF
Investigational Site Number 826-165
Dumfries, United Kingdom, DG14AP
Investigational Site Number 826-167
Durham, United Kingdom, DH15TW
Investigational Site Number 826-173
East Kilbride, United Kingdom, G758RG
Investigational Site Number 826-105
Edinburgh, United Kingdom, EH164SA
Investigational Site Number 826-115
Exeter, United Kingdom, EX25DW
Investigational Site Number 826-160
Fleetwood, United Kingdom, FY76HD
Investigational Site Number 826-107
Gateshead, United Kingdom, NE96SX
Investigational Site Number 826-127
Glasgow, United Kingdom, G213UW
Investigational Site Number 826-174
Haddington, United Kingdom, EH413PF
Investigational Site Number 826-164
Hereford, United Kingdom, HR12RE
Investigational Site Number 826-126
High Wycombe, United Kingdom, HP112TT
Investigational Site Number 826-102
Hull, United Kingdom, HU32JZ
Investigational Site Number 826-120
Ipswich, United Kingdom, IP45PD
Investigational Site Number 826-163
Kirkcaldy, United Kingdom, KY25AH
Investigational Site Number 826-161
Lancaster, United Kingdom, LA11RP
Investigational Site Number 826-101
Liverpool, United Kingdom, L78XP
Investigational Site Number 826-108
Liverpool, United Kingdom, L97AL
Investigational Site Number 826-122
Livingston, United Kingdom, EH546PP
Investigational Site Number 826-110
Llantrisant, United Kingdom, CF728XR
Investigational Site Number 826-142
London, United Kingdom, N18 1QX
Investigational Site Number 826-123
London, United Kingdom, N195NF
Investigational Site Number 826-166
London, United Kingdom, W91SP
Investigational Site Number 826-137
Manchester, United Kingdom, M85RB
Investigational Site Number 826-156
Mortimer, United Kingdom, RG7 3SQ
Investigational Site Number 826-140
Newcastle upon Tyne, United Kingdom, NE46BE
Investigational Site Number 826-138
Newport, United Kingdom, PO305TG
Investigational Site Number 826-133
Nottingham, United Kingdom, NG72UH
Investigational Site Number 826-121
Nuneaton, United Kingdom, CV107DJ
Investigational Site Number 826-129
Plymouth, United Kingdom, PL53JB
Investigational Site Number 826-116
Salford, United Kingdom, M68HD
Investigational Site Number 826-143
Scunthorpe, United Kingdom, DN15 7BH
Investigational Site Number 826-104
Sheffield, United Kingdom, S57AU
Investigational Site Number 826-103
St Helens, United Kingdom, WA93DA
Investigational Site Number 826-139
St Leonards on Sea, United Kingdom, TN377RD
Investigational Site Number 826-111
Stevenage, United Kingdom, SG14AB
Investigational Site Number 826-131
Stirling, United Kingdom, FK82AU
Investigational Site Number 826-146
Sunderland, United Kingdom, SR47TP
Investigational Site Number 826-128
Westbury, United Kingdom, BA133JD
Investigational Site Number 826-117
York, United Kingdom, YO318HE
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Christine van Schalkwyk, MD Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00965549     History of Changes
Other Study ID Numbers: LANTU_L_04211
2008-007026-19(EudraCT)
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin glulisine
Insulin aspart, insulin aspart protamine drug combination 30:70
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants