Clinical trial NCT00949442: Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 708
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: Recorded at baseline (week 0), week 12, week 24 and week 36
Secondary outcomes:
measure: Self-monitored fasting plasma glucose (FPG)
timeFrame: Before baseline (week 0), weeks 12, 24 and 36
measure: 8-points profiles
timeFrame: The week before baseline, at 12, 24 and 36 weeks
measure: Episodes of hypoglycemia
timeFrame: From the week -2 to the week 36
measure: Daily doses of insulin
timeFrame: 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
measure: Need of additional prandial insulin
timeFrame: At week 24
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076-001
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076-006
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076-005
city: Rio de Janeiro
country: Brazil
facility: Investigational Site Number 076-007
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-004
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-003
city: São Paulo
country: Brazil
facility: Investigational Site Number 076-002
city: Beroun
country: Czech Republic
facility: Investigational Site Number 203003
city: Ceske Budejovice
country: Czech Republic
facility: Investigational Site Number 203008
city: Ceske Budejovice
country: Czech Republic
facility: Investigational Site Number 203011
city: Chrudim III
country: Czech Republic
facility: Investigational Site Number 203001
city: Hodonin
country: Czech Republic
facility: Investigational Site Number 203006
city: Hranice I - Mesto
country: Czech Republic
facility: Investigational Site Number 203002
city: Liberec
country: Czech Republic
facility: Investigational Site Number 203010
city: Moravsky Pisek
country: Czech Republic
facility: Investigational Site Number 203009
city: Praha 10
country: Czech Republic
facility: Investigational Site Number 203004
city: Praha 10
country: Czech Republic
facility: Investigational Site Number 203005
city: Praha 6
country: Czech Republic
facility: Investigational Site Number 203007
city: Menoufiya
country: Egypt
facility: Investigational Site Number 818001
city: Aix En Provence
country: France
facility: Investigational Site Number 250-002
city: Antibes
country: France
facility: Investigational Site Number 250-001
city: Bordeaux
country: France
facility: Investigational Site Number 250-005
city: Jarny
country: France
facility: Investigational Site Number 250-004
city: NARBONNE Cedex
country: France
facility: Investigational Site Number 250-003
city: Strasbourg
country: France
facility: Investigational Site Number 250-006
city: Perugia
country: Italy
facility: Investigational Site Number 380001
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number 410005
city: Gyeonggi-Do
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Kuwait
country: Kuwait
facility: Investigational Site Number 414001
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484003
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484005
city: Monterrey
country: Mexico
facility: Investigational Site Number 484001
city: Pachuca
country: Mexico
facility: Investigational Site Number 484008
city: Pachuca
country: Mexico
facility: Investigational Site Number 484009
city: Puebla
country: Mexico
facility: Investigational Site Number 484002
city: Almelo
country: Netherlands
facility: Investigational Site Number 528006
city: Apeldoorn
country: Netherlands
facility: Investigational Site Number 528005
city: Beek
country: Netherlands
facility: Investigational Site Number 528001
city: Hoogeveen
country: Netherlands
facility: Investigational Site Number 528002
city: Hoogezand
country: Netherlands
facility: Investigational Site Number 528004
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 528003
city: Gdansk
country: Poland
facility: Investigational Site Number 616004
city: Kraków
country: Poland
facility: Investigational Site Number 616003
city: Lublin
country: Poland
facility: Investigational Site Number 616002
city: Zabrze
country: Poland
facility: Investigational Site Number 616001
city: Bucharest
country: Romania
facility: Investigational Site Number 642001
city: Bucharest
country: Romania
facility: Investigational Site Number 642002
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642009
city: Craiova
country: Romania
facility: Investigational Site Number 642003
city: Iasi
country: Romania
facility: Investigational Site Number 642005
city: Oradea
country: Romania
facility: Investigational Site Number 642010
city: Oradea
country: Romania
facility: Investigational Site Number 642011
city: Ploiesti
country: Romania
facility: Investigational Site Number 642007
city: Resita
country: Romania
facility: Investigational Site Number 642004
city: Targu-Mures
country: Romania
facility: Investigational Site Number 642008
city: Timisoara
country: Romania
facility: Investigational Site Number 642012
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643-001
city: Samara
country: Russian Federation
facility: Investigational Site Number 643-006
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643-005
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643-002
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643-003
city: St-Ptetersburg
country: Russian Federation
facility: Investigational Site Number 643-004
city: Tyumen
country: Russian Federation
facility: Investigational Site Number 643-007
city: Banská Bystrica
country: Slovakia
facility: Investigational Site Number 703005
city: Bratislava
country: Slovakia
facility: Investigational Site Number 703003
city: Bratislava
country: Slovakia
facility: Investigational Site Number 703007
city: Kosice
country: Slovakia
facility: Investigational Site Number 703004
city: Kosice
country: Slovakia
facility: Investigational Site Number 703006
city: Kosice
country: Slovakia
facility: Investigational Site Number 703002
city: Levice
country: Slovakia
facility: Investigational Site Number 703008
city: Martin
country: Slovakia
facility: Investigational Site Number 703001
city: Lund
country: Sweden
facility: Investigational Site Number 752004
city: Malmö
country: Sweden
facility: Investigational Site Number 752002
city: Skene
country: Sweden
facility: Investigational Site Number 752003
city: Stockholm
country: Sweden
facility: Investigational Site Number 752001
city: Geneve
country: Switzerland
facility: Investigational Site Number 756001
city: Bangkok
country: Thailand
facility: Investigational Site Number 764004
city: Bangkok
country: Thailand
facility: Investigational Site Number 764001
city: Chiangmai
country: Thailand
facility: Investigational Site Number 764002
city: Khon Kaen
country: Thailand
facility: Investigational Site Number 764003
city: Nakhonratchasima
country: Thailand
facility: Investigational Site Number 764006
city: Pathumthani
country: Thailand
facility: Investigational Site Number 764005
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 784-001
Study officials:
affiliation: Sanofi
name: Valerie Pilorget, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.