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Diabetes Mellitus, Type 2Phase 4LanScapeNCT00965549

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

A Phase 4 study testing INSULIN GLARGINE (HOE901), Insulin aspart and Insulin Glulisine in people with Diabetes Mellitus, Type 2, run by Sanofi at 74 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
INSULIN GLARGINE (HOE901), Insulin aspart and Insulin Glulisine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
463 participants
Where
74 sitesin 2 countries
Study dates
Jul 2009to Dec 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 19Show fewer
  • 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.

Trial locations and contacts

74 sites in 2 countries.

74 sites in 2 countries

United Kingdom60 sites

  • Investigational Site Number 826-109

    Aberdeen, AB251LD

  • Investigational Site Number 826-118

    Ashton-under-Lyne, OL69RW

  • Investigational Site Number 826-157

    Ayr, KA66DX

  • Investigational Site Number 826-149

    Barnsley, S752EP

  • Investigational Site Number 826-135

    Bath, BA13NG

  • Investigational Site Number 826-124

    Birmingham, B187QH

  • Investigational Site Number 826-150

    Birmingham, B95SS

  • Investigational Site Number 826-106

    Bournemouth, BH77DW

  • Investigational Site Number 826-136

    Bradford, BD96RJ

  • Investigational Site Number 826-130

    Bristol, BS105NB

  • Investigational Site Number 826-114

    Bury St Edmunds, IP332QZ

  • Investigational Site Number 826-132

    Carmarthen, SA312AF

  • Investigational Site Number 826-141

    Cheadle, SK86LU

  • Investigational Site Number 826-147

    Chester, CH21UL

  • Investigational Site Number 826-112

    Chesterfield, S404TF

  • Investigational Site Number 826-152

    Chichester, PO196SE

  • Investigational Site Number 826-159

    Cleveleys, FY53LF

  • Investigational Site Number 826-113

    Colchester, CO45JL

  • Investigational Site Number 826-119

    Cornwall, TR13LJ

  • Investigational Site Number 826-162

    Crawley, RH107DX

  • Investigational Site Number 826-145

    Dafen, SA14 8QF

  • Investigational Site Number 826-165

    Dumfries, DG14AP

  • Investigational Site Number 826-167

    Durham, DH15TW

  • Investigational Site Number 826-173

    East Kilbride, G758RG

  • Investigational Site Number 826-105

    Edinburgh, EH164SA

  • Investigational Site Number 826-115

    Exeter, EX25DW

  • Investigational Site Number 826-160

    Fleetwood, FY76HD

  • Investigational Site Number 826-107

    Gateshead, NE96SX

  • Investigational Site Number 826-127

    Glasgow, G213UW

  • Investigational Site Number 826-174

    Haddington, EH413PF

  • Investigational Site Number 826-164

    Hereford, HR12RE

  • Investigational Site Number 826-126

    High Wycombe, HP112TT

  • Investigational Site Number 826-102

    Hull, HU32JZ

  • Investigational Site Number 826-120

    Ipswich, IP45PD

  • Investigational Site Number 826-163

    Kirkcaldy, KY25AH

  • Investigational Site Number 826-161

    Lancaster, LA11RP

  • Investigational Site Number 826-101

    Liverpool, L78XP

  • Investigational Site Number 826-108

    Liverpool, L97AL

  • Investigational Site Number 826-122

    Livingston, EH546PP

  • Investigational Site Number 826-110

    Llantrisant, CF728XR

  • Investigational Site Number 826-142

    London, N18 1QX

  • Investigational Site Number 826-123

    London, N195NF

  • Investigational Site Number 826-166

    London, W91SP

  • Investigational Site Number 826-137

    Manchester, M85RB

  • Investigational Site Number 826-156

    Mortimer, RG7 3SQ

  • Investigational Site Number 826-140

    Newcastle upon Tyne, NE46BE

  • Investigational Site Number 826-138

    Newport, PO305TG

  • Investigational Site Number 826-133

    Nottingham, NG72UH

  • Investigational Site Number 826-121

    Nuneaton, CV107DJ

  • Investigational Site Number 826-129

    Plymouth, PL53JB

  • Investigational Site Number 826-139

    Saint Leonards-on-Sea, TN377RD

  • Investigational Site Number 826-116

    Salford, M68HD

  • Investigational Site Number 826-143

    Scunthorpe, DN15 7BH

  • Investigational Site Number 826-104

    Sheffield, S57AU

  • Investigational Site Number 826-103

    St Helens, WA93DA

  • Investigational Site Number 826-111

    Stevenage, SG14AB

  • Investigational Site Number 826-131

    Stirling, FK82AU

  • Investigational Site Number 826-146

    Sunderland, SR47TP

  • Investigational Site Number 826-128

    Westbury, BA133JD

  • Investigational Site Number 826-117

    York, YO318HE

Other trials in United Kingdom

Australia14 sites

  • Investigational Site Number 204

    Campbelltown, 2560

  • Investigational Site Number 205

    Campbelltown, 2560

  • Investigational Site Number 201

    Caulfield, 3162

  • Investigational Site Number 210

    Daw Park, 5041

  • Investigational Site Number 214

    Douglas, 4814

  • Investigational Site Number 203

    Heidelberg, 3081

  • Investigational Site Number 206

    Herston, 4006

  • Investigational Site Number 211

    Maroubra, 2035

  • Investigational Site Number 207

    Meadowbrook, 4131

  • Investigational Site Number 212

    Melbourne, 3065

  • Investigational Site Number 209

    Milton, 4064

  • Investigational Site Number 213

    Nowra, 2541

  • Investigational Site Number 202

    Parkville, 3050

  • Investigational Site Number 208

    Southport, 4215

Other trials in Australia

About this study

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

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
Being tested
INSULIN GLARGINE (HOE901), Insulin aspart, Insulin Glulisine
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSULIN GLARGINE (HOE901)Drug

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

  • Insulin aspartDrug

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

  • Insulin GlulisineDrug

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

Study groups in NCT00965549
Study groupRoleWhat they receive
Lantus + Apidra basal plus oneExperimentalBefore 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
Receives: Drug: INSULIN GLARGINE (HOE901); Drug: Insulin Glulisine
NovoMix 30 BiphasicActive comparatorBefore 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)
Receives: Drug: Insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycosylated Haemoglobin (HbA1c)

    Measured: At week 7 and week 32

Secondary outcomes (3)

  1. Weight

    Measured: 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)

    Measured: Week 8 and week 32

  3. Hypoglycaemia (total, severe and nocturnal)

    Measured: At week 0 and week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00965549
Sponsor's protocol ID
LANTU_L_04211
Other IDs
2008-007026-19(EudraCT), 2008
Acronym
LanScape
Status last verified
Jan 2013
First submitted
24 Aug 2009
Last updated
8 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing INSULIN GLARGINE (HOE901), Insulin aspart and Insulin Glulisine in people with Diabetes Mellitus, Type 2, run by Sanofi at 74 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycosylated Haemoglobin (HbA1c) (time frame: At week 7 and week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00965549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.

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