- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949442
Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment (LANCELOT)
Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled
Primary Objective:
To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.
Secondary Objective:
To compare between treatment groups:
- Plasma glucose (fasting, nocturnal) over time,
- Changes from baseline in HbA1c over time,
- Percentage of patients who reach the target of HbA1c <7 and <6.5,
- Use of prandial insulin as rescue medication at month 6,
- Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
- Daily dose of insulin,
- Change in body weight from baseline,
- Evolution of 8-point plasma-glucose (PG) profiles,
- Overall safety,
- Patient reported outcomes (treatment satisfaction).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Fortaleza, Brazil, 60115-282
- Investigational Site Number 076-001
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Fortaleza, Brazil, 60430-370
- Investigational Site Number 076-006
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Porto Alegre, Brazil, 90035-170
- Investigational Site Number 076-005
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Rio de Janeiro, Brazil, 202110340
- Investigational Site Number 076-007
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São Paulo, Brazil, 04024-002
- Investigational Site Number 076-002
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São Paulo, Brazil, 01221-000
- Investigational Site Number 076-004
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São Paulo, Brazil, 01244-030
- Investigational Site Number 076-003
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Beroun, Czech Republic, 26601
- Investigational Site Number 203003
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Ceske Budejovice, Czech Republic, 37001
- Investigational Site Number 203008
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Ceske Budejovice, Czech Republic, 37007
- Investigational Site Number 203011
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Chrudim III, Czech Republic, 53701
- Investigational Site Number 203001
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Hodonin, Czech Republic, 69501
- Investigational Site Number 203006
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Hranice I - Mesto, Czech Republic, 75301
- Investigational Site Number 203002
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Liberec, Czech Republic, 46001
- Investigational Site Number 203010
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Moravsky Pisek, Czech Republic, 39701
- Investigational Site Number 203009
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Praha 10, Czech Republic, 10000
- Investigational Site Number 203004
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Praha 10, Czech Republic, 10000
- Investigational Site Number 203005
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Praha 6, Czech Republic, 16300
- Investigational Site Number 203007
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Menoufiya, Egypt
- Investigational Site Number 818001
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Aix En Provence, France, 13100
- Investigational Site Number 250-002
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Antibes, France, 06600
- Investigational Site Number 250-001
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Bordeaux, France, 33200
- Investigational Site Number 250-005
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Jarny, France, 54800
- Investigational Site Number 250-004
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NARBONNE Cedex, France, 11018
- Investigational Site Number 250-003
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Strasbourg, France, 67000
- Investigational Site Number 250-006
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Perugia, Italy, 06156
- Investigational Site Number 380001
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Daegu, Korea, Republic of
- Investigational Site Number 410005
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Gyeonggi-Do, Korea, Republic of, 420-717
- Investigational Site Number 410002
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Incheon, Korea, Republic of, 400-711
- Investigational Site Number 410006
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Seoul, Korea, Republic of
- Investigational Site Number 410004
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Seoul, Korea, Republic of
- Investigational Site Number 410003
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Seoul, Korea, Republic of, 137-701
- Investigational Site Number 410001
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Kuwait, Kuwait
- Investigational Site Number 414001
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Guadalajara, Mexico, 44150
- Investigational Site Number 484003
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Guadalajara, Mexico, 44650
- Investigational Site Number 484005
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Monterrey, Mexico, 64710
- Investigational Site Number 484001
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Pachuca, Mexico, 042090
- Investigational Site Number 484008
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Pachuca, Mexico, 42086
- Investigational Site Number 484009
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Puebla, Mexico, 72190
- Investigational Site Number 484002
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Almelo, Netherlands, 7600SZ
- Investigational Site Number 528006
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Apeldoorn, Netherlands, 7314 ET
- Investigational Site Number 528005
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Beek, Netherlands, 6191JW
- Investigational Site Number 528001
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Hoogeveen, Netherlands, 7909AA
- Investigational Site Number 528002
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Hoogezand, Netherlands, 9603AE
- Investigational Site Number 528004
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Rotterdam, Netherlands, 3053CD
- Investigational Site Number 528003
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Gdansk, Poland, 80-211
- Investigational Site Number 616004
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Kraków, Poland, 31-262
- Investigational Site Number 616003
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Lublin, Poland, 20-954
- Investigational Site Number 616002
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Zabrze, Poland, 41-800
- Investigational Site Number 616001
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Bucharest, Romania
- Investigational Site Number 642001
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Bucharest, Romania
- Investigational Site Number 642002
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Cluj-Napoca, Romania
- Investigational Site Number 642009
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Craiova, Romania
- Investigational Site Number 642003
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Iasi, Romania
- Investigational Site Number 642005
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Oradea, Romania
- Investigational Site Number 642010
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Oradea, Romania
- Investigational Site Number 642011
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Ploiesti, Romania
- Investigational Site Number 642007
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Resita, Romania
- Investigational Site Number 642004
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Targu-Mures, Romania
- Investigational Site Number 642008
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Timisoara, Romania
- Investigational Site Number 642012
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Moscow, Russian Federation
- Investigational Site Number 643-001
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Samara, Russian Federation
- Investigational Site Number 643-006
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Saratov, Russian Federation
- Investigational Site Number 643-005
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St-Petersburg, Russian Federation, 195257
- Investigational Site Number 643-002
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St-Petersburg, Russian Federation
- Investigational Site Number 643-003
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St-Ptetersburg, Russian Federation, 194354
- Investigational Site Number 643-004
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Tyumen, Russian Federation, 625046
- Investigational Site Number 643-007
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Banská Bystrica, Slovakia, 97517
- Investigational Site Number 703005
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Bratislava, Slovakia, 81102
- Investigational Site Number 703003
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Bratislava, Slovakia, 82606
- Investigational Site Number 703007
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Kosice, Slovakia, 04011
- Investigational Site Number 703002
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Kosice, Slovakia, 04001
- Investigational Site Number 703004
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Kosice, Slovakia, 04001
- Investigational Site Number 703006
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Levice, Slovakia, 93401
- Investigational Site Number 703008
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Martin, Slovakia, 03659
- Investigational Site Number 703001
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Lund, Sweden, 22361
- Investigational Site Number 752004
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Malmö, Sweden, 21120
- Investigational Site Number 752002
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Skene, Sweden, 51162
- Investigational Site Number 752003
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Stockholm, Sweden, 17176
- Investigational Site Number 752001
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Geneve, Switzerland, 1205
- Investigational Site Number 756001
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Bangkok, Thailand, 10400
- Investigational Site Number 764001
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Bangkok, Thailand, 10330
- Investigational Site Number 764004
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Chiangmai, Thailand, 50002
- Investigational Site Number 764002
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Khon Kaen, Thailand, 40002
- Investigational Site Number 764003
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Nakhonratchasima, Thailand, 30000
- Investigational Site Number 764006
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Pathumthani, Thailand, 12120
- Investigational Site Number 764005
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Dubai, United Arab Emirates, 4545
- Investigational Site Number 784-001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Insulin-naïve type 2 diabetes mellitus
- Type 2 diabetes mellitus diagnosed for at least 1 year
- Treated with at least one OAD (Metformin [daily dose of at least 1000mg], Sulfonylurea, glinides or alpha-glucosidase inhibitor) at stable dose for at least 3 months.
- HbA1c > or = 7.0% and < or = 10.5%
- BMI < 40 kg/m²
- Ability and willingness to perform plasma glucose monitoring using the sponsor-provided glucose meter and patient diary at home
- Informed consent obtained in writing at enrolment into the study
- Willingness and ability to comply with the study protocol
Exclusion criteria:
- Treatment with GLP-1 agonists or with DPP-IV inhibitors in the 3 months prior to study entry
- Treatment with TZD as monotherapy
- Diabetes mellitus other than Type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake...)
- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)
- Impaired renal function: serum creatinine > or =1.5 mg/dL (> or = 133µmol/L) or > or = 1.4 mg/dL (> or = 124 µmol/L) in men and women, respectively
- History of sensitivity to the study drugs or to drugs with a similar chemical structure
- Impaired hepatic function (ALT and/or AST > 3 x upper limit of normal range)
- Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
- Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.
- Treatment with an investigational product in the 30 days prior to visit 1
- Alcohol or drug abuse in the last year
- Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient's safety or limit the patient successful participation in the study (including night shift worker)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Before randomization (common with arm 2): 2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride After randomization: 36 weeks of study treatment phase: Insulin Glargine + OAD(s) at stable dose |
100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
tablets of 1 and 2 mg
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Active Comparator: 2
Before randomization (common with arm 1): 2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride After randomization: 36 weeks of study treatment phase: NPH + OAD(s) at stable dose |
tablets of 1 and 2 mg
100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: Recorded at baseline (week 0), week 12, week 24 and week 36
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Recorded at baseline (week 0), week 12, week 24 and week 36
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-monitored fasting plasma glucose (FPG)
Time Frame: Before baseline (week 0), weeks 12, 24 and 36
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Before baseline (week 0), weeks 12, 24 and 36
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8-points profiles
Time Frame: The week before baseline, at 12, 24 and 36 weeks
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The week before baseline, at 12, 24 and 36 weeks
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Episodes of hypoglycemia
Time Frame: From the week -2 to the week 36
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From the week -2 to the week 36
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Daily doses of insulin
Time Frame: At week 1, week 2, week 3, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 20, week 24, week 28, week 32, week 36
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At week 1, week 2, week 3, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 20, week 24, week 28, week 32, week 36
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Need of additional prandial insulin
Time Frame: At week 24
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At week 24
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
- Home PD, Bolli GB, Mathieu C, Deerochanawong C, Landgraf W, Candelas C, Pilorget V, Dain MP, Riddle MC. Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naive people with type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):15-22. doi: 10.1111/dom.12329. Epub 2014 Jul 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LANTU_C_02762
- EUDRACT #: 2007-006640-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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