Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment

Diabetes Mellitus, Type 2 Clinical Trial

— LANCELOT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949442
• Other study ID #: LANTU_C_02762
• Secondary ID: EUDRACT #: 2007-
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2009
• Last updated: August 20, 2012
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Brazil	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 076-002	São Paulo
Brazil	Investigational Site Number 076-003	São Paulo
Brazil	Investigational Site Number 076-004	São Paulo
Czech Republic	Investigational Site Number 203003	Beroun
Czech Republic	Investigational Site Number 203008	Ceske Budejovice
Czech Republic	Investigational Site Number 203011	Ceske Budejovice
Czech Republic	Investigational Site Number 203001	Chrudim III
Czech Republic	Investigational Site Number 203006	Hodonin
Czech Republic	Investigational Site Number 203002	Hranice I - Mesto
Czech Republic	Investigational Site Number 203010	Liberec
Czech Republic	Investigational Site Number 203009	Moravsky Pisek
Czech Republic	Investigational Site Number 203004	Praha 10
Czech Republic	Investigational Site Number 203005	Praha 10
Czech Republic	Investigational Site Number 203007	Praha 6
Egypt	Investigational Site Number 818001	Menoufiya
France	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 Cedex
France	Investigational Site Number 250-006	Strasbourg
Italy	Investigational Site Number 380001	Perugia
Korea, Republic of	Investigational Site Number 410005	Daegu
Korea, Republic of	Investigational Site Number 410002	Gyeonggi-Do
Korea, Republic of	Investigational Site Number 410006	Incheon
Korea, Republic of	Investigational Site Number 410001	Seoul
Korea, Republic of	Investigational Site Number 410003	Seoul
Korea, Republic of	Investigational Site Number 410004	Seoul
Kuwait	Investigational Site Number 414001	Kuwait
Mexico	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
Netherlands	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
Poland	Investigational Site Number 616004	Gdansk
Poland	Investigational Site Number 616003	Kraków
Poland	Investigational Site Number 616002	Lublin
Poland	Investigational Site Number 616001	Zabrze
Romania	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	Iasi
Romania	Investigational Site Number 642010	Oradea
Romania	Investigational Site Number 642011	Oradea
Romania	Investigational Site Number 642007	Ploiesti
Romania	Investigational Site Number 642004	Resita
Romania	Investigational Site Number 642008	Targu-Mures
Romania	Investigational Site Number 642012	Timisoara
Russian Federation	Investigational Site Number 643-001	Moscow
Russian Federation	Investigational Site Number 643-006	Samara
Russian Federation	Investigational Site Number 643-005	Saratov
Russian Federation	Investigational Site Number 643-002	St-Petersburg
Russian Federation	Investigational Site Number 643-003	St-Petersburg
Russian Federation	Investigational Site Number 643-004	St-Ptetersburg
Russian Federation	Investigational Site Number 643-007	Tyumen
Slovakia	Investigational Site Number 703005	Banská Bystrica
Slovakia	Investigational Site Number 703003	Bratislava
Slovakia	Investigational Site Number 703007	Bratislava
Slovakia	Investigational Site Number 703002	Kosice
Slovakia	Investigational Site Number 703004	Kosice
Slovakia	Investigational Site Number 703006	Kosice
Slovakia	Investigational Site Number 703008	Levice
Slovakia	Investigational Site Number 703001	Martin
Sweden	Investigational Site Number 752004	Lund
Sweden	Investigational Site Number 752002	Malmö
Sweden	Investigational Site Number 752003	Skene
Sweden	Investigational Site Number 752001	Stockholm
Switzerland	Investigational Site Number 756001	Geneve
Thailand	Investigational Site Number 764001	Bangkok
Thailand	Investigational Site Number 764004	Bangkok
Thailand	Investigational Site Number 764002	Chiangmai
Thailand	Investigational Site Number 764003	Khon Kaen
Thailand	Investigational Site Number 764006	Nakhonratchasima
Thailand	Investigational Site Number 764005	Pathumthani
United Arab Emirates	Investigational Site Number 784-001	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Brazil,  Czech Republic,  Egypt,  France,  Italy,  Korea, Republic of,  Kuwait,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Slovakia,  Sweden,  Switzerland,  Thailand,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		Recorded at baseline (week 0), week 12, week 24 and week 36	No
Secondary	Self-monitored fasting plasma glucose (FPG)		Before baseline (week 0), weeks 12, 24 and 36	No
Secondary	8-points profiles		The week before baseline, at 12, 24 and 36 weeks	No
Secondary	Episodes of hypoglycemia		From the week -2 to the week 36	No
Secondary	Daily doses of insulin		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	No
Secondary	Need of additional prandial insulin		At week 24	No