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

NCT00949442 | Completed Phase 4

• 2 other identifiers: LANTU_C_02762EUDRACT #: 2007-006640-22
• Study Type: interventional
• Target: 708
• Locations: 17 countries
• Sites: 87

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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Recorded at baseline (week 0), week 12, week 24 and week 36

Secondary Outcomes (5)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Insulin Glargine (HOE901) [Lantus]; Drug: Glimepiride

2

ACTIVE COMPARATOR

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

Drug: Glimepiride; Drug: human insulin [NPH]

Interventions

Insulin Glargine (HOE901) [Lantus] DRUG

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

1

Glimepiride DRUG

tablets of 1 and 2 mg

1; 2

human insulin [NPH] DRUG

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

2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (87)

Investigational Site Number 076-001

Fortaleza, 60115-282, Brazil

Location

Investigational Site Number 076-006

Fortaleza, 60430-370, Brazil

Location

Investigational Site Number 076-005

Porto Alegre, 90035-170, Brazil

Location

Investigational Site Number 076-007

Rio de Janeiro, 202110340, Brazil

Location

Investigational Site Number 076-004

São Paulo, 01221-000, Brazil

Location

Investigational Site Number 076-003

São Paulo, 01244-030, Brazil

Location

Investigational Site Number 076-002

São Paulo, 04024-002, Brazil

Location

Investigational Site Number 203003

Beroun, 26601, Czechia

Location

Investigational Site Number 203001

Chrudim III, 53701, Czechia

Location

Investigational Site Number 203008

České Budějovice, 37001, Czechia

Location

Investigational Site Number 203011

České Budějovice, 37007, Czechia

Location

Investigational Site Number 203006

Hodonín, 69501, Czechia

Location

Investigational Site Number 203002

Hranice I - Mesto, 75301, Czechia

Location

Investigational Site Number 203010

Liberec, 46001, Czechia

Location

Investigational Site Number 203009

Moravský Písek, 39701, Czechia

Location

Investigational Site Number 203004

Prague, 10000, Czechia

Location

Investigational Site Number 203005

Prague, 10000, Czechia

Location

Investigational Site Number 203007

Prague, 16300, Czechia

Location

Investigational Site Number 818001

Menoufiya, Egypt

Location

Investigational Site Number 250-002

Aix-en-Provence, 13100, France

Location

Investigational Site Number 250-001

Antibes, 06600, France

Location

Investigational Site Number 250-005

Bordeaux, 33200, France

Location

Investigational Site Number 250-004

Jarny, 54800, France

Location

Investigational Site Number 250-003

Narbonne, 11018, France

Location

Investigational Site Number 250-006

Strasbourg, 67000, France

Location

Investigational Site Number 380001

Perugia, 06156, Italy

Location

Investigational Site Number 414001

Kuwait City, Kuwait

Location

Investigational Site Number 484003

Guadalajara, 44150, Mexico

Location

Investigational Site Number 484005

Guadalajara, 44650, Mexico

Location

Investigational Site Number 484001

Monterrey, 64710, Mexico

Location

Investigational Site Number 484008

Pachuca, 042090, Mexico

Location

Investigational Site Number 484009

Pachuca, 42086, Mexico

Location

Investigational Site Number 484002

Puebla City, 72190, Mexico

Location

Investigational Site Number 528006

Almelo, 7600SZ, Netherlands

Location

Investigational Site Number 528005

Apeldoorn, 7314 ET, Netherlands

Location

Investigational Site Number 528001

Beek, 6191JW, Netherlands

Location

Investigational Site Number 528002

Hoogeveen, 7909AA, Netherlands

Location

Investigational Site Number 528004

Hoogezand, 9603AE, Netherlands

Location

Investigational Site Number 528003

Rotterdam, 3053CD, Netherlands

Location

Investigational Site Number 616004

Gdansk, 80-211, Poland

Location

Investigational Site Number 616003

Krakow, 31-262, Poland

Location

Investigational Site Number 616002

Lublin, 20-954, Poland

Location

Investigational Site Number 616001

Zabrze, 41-800, Poland

Location

Investigational Site Number 642001

Bucharest, Romania

Location

Investigational Site Number 642002

Bucharest, Romania

Location

Investigational Site Number 642009

Cluj-Napoca, Romania

Location

Investigational Site Number 642003

Craiova, Romania

Location

Investigational Site Number 642005

Iași, Romania

Location

Investigational Site Number 642010

Oradea, Romania

Location

Investigational Site Number 642011

Oradea, Romania

Location

Investigational Site Number 642007

Ploieşti, Romania

Location

Investigational Site Number 642004

Reşiţa, Romania

Location

Investigational Site Number 642008

Târgu Mureş, Romania

Location

Investigational Site Number 642012

Timișoara, Romania

Location

Investigational Site Number 643-001

Moscow, Russia

Location

Investigational Site Number 643-002

Saint Petersburg, 195257, Russia

Location

Investigational Site Number 643-003

Saint Petersburg, Russia

Location

Investigational Site Number 643-006

Samara, Russia

Location

Investigational Site Number 643-005

Saratov, Russia

Location

Investigational Site Number 643-004

St-Ptetersburg, 194354, Russia

Location

Investigational Site Number 643-007

Tyumen, 625046, Russia

Location

Investigational Site Number 703005

Banská Bystrica, 97517, Slovakia

Location

Investigational Site Number 703003

Bratislava, 81102, Slovakia

Location

Investigational Site Number 703007

Bratislava, 82606, Slovakia

Location

Investigational Site Number 703004

Košice, 04001, Slovakia

Location

Investigational Site Number 703006

Košice, 04001, Slovakia

Location

Investigational Site Number 703002

Košice, 04011, Slovakia

Location

Investigational Site Number 703008

Levice, 93401, Slovakia

Location

Investigational Site Number 703001

Martin, 03659, Slovakia

Location

Investigational Site Number 410005

Daegu, South Korea

Location

Investigational Site Number 410002

Gyeonggi-do, 420-717, South Korea

Location

Investigational Site Number 410006

Incheon, 400-711, South Korea

Location

Investigational Site Number 410001

Seoul, 137-701, South Korea

Location

Investigational Site Number 410003

Seoul, South Korea

Location

Investigational Site Number 410004

Seoul, South Korea

Location

Investigational Site Number 752004

Lund, 22361, Sweden

Location

Investigational Site Number 752002

Malmo, 21120, Sweden

Location

Investigational Site Number 752003

Skene, 51162, Sweden

Location

Investigational Site Number 752001

Stockholm, 17176, Sweden

Location

Investigational Site Number 756001

Geneva, 1205, Switzerland

Location

Investigational Site Number 764004

Bangkok, 10330, Thailand

Location

Investigational Site Number 764001

Bangkok, 10400, Thailand

Location

Investigational Site Number 764002

Chiang Mai, 50002, Thailand

Location

Investigational Site Number 764003

Khon Kaen, 40002, Thailand

Location

Investigational Site Number 764006

Nakhonratchasima, 30000, Thailand

Location

Investigational Site Number 764005

Pathum Thani, 12120, Thailand

Location

Investigational Site Number 784-001

Dubai, 4545, United Arab Emirates

Location

Related Publications (2)

• 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.

  PMID: 33166419 DERIVED

• 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.

  PMID: 24957785 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; glimepiride; Insulin, Isophane

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Valerie Pilorget, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 30, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 21, 2012

Record last verified: 2012-08

Locations

TH (6); IT (1); PL (4); CH (1); BR (7); KU (1); KR (6); AE (1); RU (7); EG (1); SE (4); FR (6); RO (11); ME (6); CZ (11); NL (6); SL (8)