Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment
NCT ID: NCT00949442
Last Updated: 2012-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
708 participants
INTERVENTIONAL
2009-07-31
2012-07-31
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Insulin Glargine (HOE901) [Lantus]
100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
Glimepiride
tablets of 1 and 2 mg
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
Glimepiride
tablets of 1 and 2 mg
human insulin [NPH]
100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)
Interventions
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Insulin Glargine (HOE901) [Lantus]
100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
Glimepiride
tablets of 1 and 2 mg
human insulin [NPH]
100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Valerie Pilorget, MD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 076-001
Fortaleza, , Brazil
Investigational Site Number 076-006
Fortaleza, , Brazil
Investigational Site Number 076-005
Porto Alegre, , Brazil
Investigational Site Number 076-007
Rio de Janeiro, , Brazil
Investigational Site Number 076-004
São Paulo, , Brazil
Investigational Site Number 076-003
São Paulo, , Brazil
Investigational Site Number 076-002
São Paulo, , Brazil
Investigational Site Number 203003
Beroun, , Czechia
Investigational Site Number 203001
Chrudim III, , Czechia
Investigational Site Number 203008
České Budějovice, , Czechia
Investigational Site Number 203011
České Budějovice, , Czechia
Investigational Site Number 203006
Hodonín, , Czechia
Investigational Site Number 203002
Hranice I - Mesto, , Czechia
Investigational Site Number 203010
Liberec, , Czechia
Investigational Site Number 203009
Moravský Písek, , Czechia
Investigational Site Number 203004
Prague, , Czechia
Investigational Site Number 203005
Prague, , Czechia
Investigational Site Number 203007
Prague, , Czechia
Investigational Site Number 818001
Menoufiya, , Egypt
Investigational Site Number 250-002
Aix-en-Provence, , France
Investigational Site Number 250-001
Antibes, , France
Investigational Site Number 250-005
Bordeaux, , France
Investigational Site Number 250-004
Jarny, , France
Investigational Site Number 250-003
Narbonne, , France
Investigational Site Number 250-006
Strasbourg, , France
Investigational Site Number 380001
Perugia, , Italy
Investigational Site Number 414001
Kuwait City, , Kuwait
Investigational Site Number 484003
Guadalajara, , Mexico
Investigational Site Number 484005
Guadalajara, , Mexico
Investigational Site Number 484001
Monterrey, , Mexico
Investigational Site Number 484008
Pachuca, , Mexico
Investigational Site Number 484009
Pachuca, , Mexico
Investigational Site Number 484002
Puebla City, , Mexico
Investigational Site Number 528006
Almelo, , Netherlands
Investigational Site Number 528005
Apeldoorn, , Netherlands
Investigational Site Number 528001
Beek, , Netherlands
Investigational Site Number 528002
Hoogeveen, , Netherlands
Investigational Site Number 528004
Hoogezand, , Netherlands
Investigational Site Number 528003
Rotterdam, , Netherlands
Investigational Site Number 616004
Gdansk, , Poland
Investigational Site Number 616003
Krakow, , Poland
Investigational Site Number 616002
Lublin, , Poland
Investigational Site Number 616001
Zabrze, , Poland
Investigational Site Number 642001
Bucharest, , Romania
Investigational Site Number 642002
Bucharest, , Romania
Investigational Site Number 642009
Cluj-Napoca, , Romania
Investigational Site Number 642003
Craiova, , Romania
Investigational Site Number 642005
Iași, , Romania
Investigational Site Number 642010
Oradea, , Romania
Investigational Site Number 642011
Oradea, , Romania
Investigational Site Number 642007
Ploieşti, , Romania
Investigational Site Number 642004
Reşiţa, , Romania
Investigational Site Number 642008
Târgu Mureş, , Romania
Investigational Site Number 642012
Timișoara, , Romania
Investigational Site Number 643-001
Moscow, , Russia
Investigational Site Number 643-002
Saint Petersburg, , Russia
Investigational Site Number 643-003
Saint Petersburg, , Russia
Investigational Site Number 643-006
Samara, , Russia
Investigational Site Number 643-005
Saratov, , Russia
Investigational Site Number 643-004
St-Ptetersburg, , Russia
Investigational Site Number 643-007
Tyumen, , Russia
Investigational Site Number 703005
Banská Bystrica, , Slovakia
Investigational Site Number 703003
Bratislava, , Slovakia
Investigational Site Number 703007
Bratislava, , Slovakia
Investigational Site Number 703004
Košice, , Slovakia
Investigational Site Number 703006
Košice, , Slovakia
Investigational Site Number 703002
Košice, , Slovakia
Investigational Site Number 703008
Levice, , Slovakia
Investigational Site Number 703001
Martin, , Slovakia
Investigational Site Number 410005
Daegu, , South Korea
Investigational Site Number 410002
Gyeonggi-do, , South Korea
Investigational Site Number 410006
Incheon, , South Korea
Investigational Site Number 410001
Seoul, , South Korea
Investigational Site Number 410003
Seoul, , South Korea
Investigational Site Number 410004
Seoul, , South Korea
Investigational Site Number 752004
Lund, , Sweden
Investigational Site Number 752002
Malmo, , Sweden
Investigational Site Number 752003
Skene, , Sweden
Investigational Site Number 752001
Stockholm, , Sweden
Investigational Site Number 756001
Geneva, , Switzerland
Investigational Site Number 764004
Bangkok, , Thailand
Investigational Site Number 764001
Bangkok, , Thailand
Investigational Site Number 764002
Chiang Mai, , Thailand
Investigational Site Number 764003
Khon Kaen, , Thailand
Investigational Site Number 764006
Nakhonratchasima, , Thailand
Investigational Site Number 764005
Pathum Thani, , Thailand
Investigational Site Number 784-001
Dubai, , United Arab Emirates
Countries
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References
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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.
Other Identifiers
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EUDRACT #: 2007-006640-22
Identifier Type: -
Identifier Source: secondary_id
LANTU_C_02762
Identifier Type: -
Identifier Source: org_study_id