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

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

Sponsors

Lead Sponsor: Sanofi

Source Sanofi
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).

Overall Status Completed
Start Date July 2009
Completion Date July 2012
Primary Completion Date July 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
HbA1c Recorded at baseline (week 0), week 12, week 24 and week 36
Secondary Outcome
Measure Time Frame
Self-monitored fasting plasma glucose (FPG) Before baseline (week 0), weeks 12, 24 and 36
8-points profiles The week before baseline, at 12, 24 and 36 weeks
Episodes of hypoglycemia From the week -2 to the week 36
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
Need of additional prandial insulin At week 24
Enrollment 708
Condition
Intervention

Intervention Type: Drug

Intervention Name: Insulin Glargine (HOE901) [Lantus]

Description: 100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: Glimepiride

Description: tablets of 1 and 2 mg

Intervention Type: Drug

Intervention Name: human insulin [NPH]

Description: 100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)

Arm Group Label: 2

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.

Gender: All

Minimum Age: 30 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Valerie Pilorget, MD Study Director Sanofi
Location
Facility:
Investigational Site Number 076-001 | Fortaleza, 60115-282, Brazil
Investigational Site Number 076-006 | Fortaleza, 60430-370, Brazil
Investigational Site Number 076-005 | Porto Alegre, 90035-170, Brazil
Investigational Site Number 076-007 | Rio de Janeiro, 202110340, Brazil
Investigational Site Number 076-004 | São Paulo, 01221-000, Brazil
Investigational Site Number 076-003 | São Paulo, 01244-030, Brazil
Investigational Site Number 076-002 | São Paulo, 04024-002, Brazil
Investigational Site Number 203003 | Beroun, 26601, Czech Republic
Investigational Site Number 203008 | Ceske Budejovice, 37001, Czech Republic
Investigational Site Number 203011 | Ceske Budejovice, 37007, Czech Republic
Investigational Site Number 203001 | Chrudim III, 53701, Czech Republic
Investigational Site Number 203006 | Hodonin, 69501, Czech Republic
Investigational Site Number 203002 | Hranice I - Mesto, 75301, Czech Republic
Investigational Site Number 203010 | Liberec, 46001, Czech Republic
Investigational Site Number 203009 | Moravsky Pisek, 39701, Czech Republic
Investigational Site Number 203004 | Praha 10, 10000, Czech Republic
Investigational Site Number 203005 | Praha 10, 10000, Czech Republic
Investigational Site Number 203007 | Praha 6, 16300, Czech Republic
Investigational Site Number 818001 | Menoufiya, Egypt
Investigational Site Number 250-002 | Aix En Provence, 13100, France
Investigational Site Number 250-001 | Antibes, 06600, France
Investigational Site Number 250-005 | Bordeaux, 33200, France
Investigational Site Number 250-004 | Jarny, 54800, France
Investigational Site Number 250-003 | NARBONNE Cedex, 11018, France
Investigational Site Number 250-006 | Strasbourg, 67000, France
Investigational Site Number 380001 | Perugia, 06156, Italy
Investigational Site Number 410005 | Daegu, Korea, Republic of
Investigational Site Number 410002 | Gyeonggi-Do, 420-717, Korea, Republic of
Investigational Site Number 410006 | Incheon, 400-711, Korea, Republic of
Investigational Site Number 410001 | Seoul, 137-701, Korea, Republic of
Investigational Site Number 410003 | Seoul, Korea, Republic of
Investigational Site Number 410004 | Seoul, Korea, Republic of
Investigational Site Number 414001 | Kuwait, Kuwait
Investigational Site Number 484003 | Guadalajara, 44150, Mexico
Investigational Site Number 484005 | Guadalajara, 44650, Mexico
Investigational Site Number 484001 | Monterrey, 64710, Mexico
Investigational Site Number 484008 | Pachuca, 042090, Mexico
Investigational Site Number 484009 | Pachuca, 42086, Mexico
Investigational Site Number 484002 | Puebla, 72190, Mexico
Investigational Site Number 528006 | Almelo, 7600SZ, Netherlands
Investigational Site Number 528005 | Apeldoorn, 7314 ET, Netherlands
Investigational Site Number 528001 | Beek, 6191JW, Netherlands
Investigational Site Number 528002 | Hoogeveen, 7909AA, Netherlands
Investigational Site Number 528004 | Hoogezand, 9603AE, Netherlands
Investigational Site Number 528003 | Rotterdam, 3053CD, Netherlands
Investigational Site Number 616004 | Gdansk, 80-211, Poland
Investigational Site Number 616003 | Kraków, 31-262, Poland
Investigational Site Number 616002 | Lublin, 20-954, Poland
Investigational Site Number 616001 | Zabrze, 41-800, 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 | 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, Romania
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, 195257, Russian Federation
Investigational Site Number 643-003 | St-Petersburg, Russian Federation
Investigational Site Number 643-004 | St-Ptetersburg, 194354, Russian Federation
Investigational Site Number 643-007 | Tyumen, 625046, Russian Federation
Investigational Site Number 703005 | Banská Bystrica, 97517, Slovakia
Investigational Site Number 703003 | Bratislava, 81102, Slovakia
Investigational Site Number 703007 | Bratislava, 82606, Slovakia
Investigational Site Number 703004 | Kosice, 04001, Slovakia
Investigational Site Number 703006 | Kosice, 04001, Slovakia
Investigational Site Number 703002 | Kosice, 04011, Slovakia
Investigational Site Number 703008 | Levice, 93401, Slovakia
Investigational Site Number 703001 | Martin, 03659, Slovakia
Investigational Site Number 752004 | Lund, 22361, Sweden
Investigational Site Number 752002 | Malmö, 21120, Sweden
Investigational Site Number 752003 | Skene, 51162, Sweden
Investigational Site Number 752001 | Stockholm, 17176, Sweden
Investigational Site Number 756001 | Geneve, 1205, Switzerland
Investigational Site Number 764004 | Bangkok, 10330, Thailand
Investigational Site Number 764001 | Bangkok, 10400, Thailand
Investigational Site Number 764002 | Chiangmai, 50002, Thailand
Investigational Site Number 764003 | Khon Kaen, 40002, Thailand
Investigational Site Number 764006 | Nakhonratchasima, 30000, Thailand
Investigational Site Number 764005 | Pathumthani, 12120, Thailand
Investigational Site Number 784-001 | Dubai, 4545, United Arab Emirates
Location Countries

Brazil

Czech Republic

Egypt

France

Italy

Korea, Republic of

Kuwait

Mexico

Netherlands

Poland

Romania

Russian Federation

Slovakia

Sweden

Switzerland

Thailand

United Arab Emirates

Verification Date

August 2012

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Description: 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

Label: 2

Type: Active Comparator

Description: 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

Acronym LANCELOT
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov