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

August 20, 2012 updated by: Sanofi

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

708

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Fortaleza, Brazil, 60115-282
        • Investigational Site Number 076-001
      • Fortaleza, Brazil, 60430-370
        • Investigational Site Number 076-006
      • Porto Alegre, Brazil, 90035-170
        • Investigational Site Number 076-005
      • Rio de Janeiro, Brazil, 202110340
        • Investigational Site Number 076-007
      • São Paulo, Brazil, 04024-002
        • Investigational Site Number 076-002
      • São Paulo, Brazil, 01221-000
        • Investigational Site Number 076-004
      • São Paulo, Brazil, 01244-030
        • Investigational Site Number 076-003
  • Czech Republic
      • Beroun, Czech Republic, 26601
        • Investigational Site Number 203003
      • Ceske Budejovice, Czech Republic, 37001
        • Investigational Site Number 203008
      • Ceske Budejovice, Czech Republic, 37007
        • Investigational Site Number 203011
      • Chrudim III, Czech Republic, 53701
        • Investigational Site Number 203001
      • Hodonin, Czech Republic, 69501
        • Investigational Site Number 203006
      • Hranice I - Mesto, Czech Republic, 75301
        • Investigational Site Number 203002
      • Liberec, Czech Republic, 46001
        • Investigational Site Number 203010
      • Moravsky Pisek, Czech Republic, 39701
        • Investigational Site Number 203009
      • Praha 10, Czech Republic, 10000
        • Investigational Site Number 203004
      • Praha 10, Czech Republic, 10000
        • Investigational Site Number 203005
      • Praha 6, Czech Republic, 16300
        • Investigational Site Number 203007
  • Egypt
      • Menoufiya, Egypt
        • Investigational Site Number 818001
  • France
      • Aix En Provence, France, 13100
        • Investigational Site Number 250-002
      • Antibes, France, 06600
        • Investigational Site Number 250-001
      • Bordeaux, France, 33200
        • Investigational Site Number 250-005
      • Jarny, France, 54800
        • Investigational Site Number 250-004
      • NARBONNE Cedex, France, 11018
        • Investigational Site Number 250-003
      • Strasbourg, France, 67000
        • Investigational Site Number 250-006
  • Italy
      • Perugia, Italy, 06156
        • Investigational Site Number 380001
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Investigational Site Number 410005
      • Gyeonggi-Do, Korea, Republic of, 420-717
        • Investigational Site Number 410002
      • Incheon, Korea, Republic of, 400-711
        • Investigational Site Number 410006
      • Seoul, Korea, Republic of
        • Investigational Site Number 410004
      • Seoul, Korea, Republic of
        • Investigational Site Number 410003
      • Seoul, Korea, Republic of, 137-701
        • Investigational Site Number 410001
  • Kuwait
      • Kuwait, Kuwait
        • Investigational Site Number 414001
  • Mexico
      • Guadalajara, Mexico, 44150
        • Investigational Site Number 484003
      • Guadalajara, Mexico, 44650
        • Investigational Site Number 484005
      • Monterrey, Mexico, 64710
        • Investigational Site Number 484001
      • Pachuca, Mexico, 042090
        • Investigational Site Number 484008
      • Pachuca, Mexico, 42086
        • Investigational Site Number 484009
      • Puebla, Mexico, 72190
        • Investigational Site Number 484002
  • Netherlands
      • Almelo, Netherlands, 7600SZ
        • Investigational Site Number 528006
      • Apeldoorn, Netherlands, 7314 ET
        • Investigational Site Number 528005
      • Beek, Netherlands, 6191JW
        • Investigational Site Number 528001
      • Hoogeveen, Netherlands, 7909AA
        • Investigational Site Number 528002
      • Hoogezand, Netherlands, 9603AE
        • Investigational Site Number 528004
      • Rotterdam, Netherlands, 3053CD
        • Investigational Site Number 528003
  • Poland
      • Gdansk, Poland, 80-211
        • Investigational Site Number 616004
      • Kraków, Poland, 31-262
        • Investigational Site Number 616003
      • Lublin, Poland, 20-954
        • Investigational Site Number 616002
      • Zabrze, Poland, 41-800
        • Investigational Site Number 616001
  • Romania
      • Bucharest, Romania
        • Investigational Site Number 642001
      • Bucharest, Romania
        • Investigational Site Number 642002
      • Cluj-Napoca, Romania
        • Investigational Site Number 642009
      • Craiova, Romania
        • Investigational Site Number 642003
      • Iasi, Romania
        • Investigational Site Number 642005
      • Oradea, Romania
        • Investigational Site Number 642010
      • Oradea, Romania
        • Investigational Site Number 642011
      • Ploiesti, Romania
        • Investigational Site Number 642007
      • Resita, Romania
        • Investigational Site Number 642004
      • Targu-Mures, Romania
        • Investigational Site Number 642008
      • Timisoara, Romania
        • Investigational Site Number 642012
  • Russian Federation
      • Moscow, Russian Federation
        • Investigational Site Number 643-001
      • Samara, Russian Federation
        • Investigational Site Number 643-006
      • Saratov, Russian Federation
        • Investigational Site Number 643-005
      • St-Petersburg, Russian Federation, 195257
        • Investigational Site Number 643-002
      • St-Petersburg, Russian Federation
        • Investigational Site Number 643-003
      • St-Ptetersburg, Russian Federation, 194354
        • Investigational Site Number 643-004
      • Tyumen, Russian Federation, 625046
        • Investigational Site Number 643-007
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Investigational Site Number 703005
      • Bratislava, Slovakia, 81102
        • Investigational Site Number 703003
      • Bratislava, Slovakia, 82606
        • Investigational Site Number 703007
      • Kosice, Slovakia, 04011
        • Investigational Site Number 703002
      • Kosice, Slovakia, 04001
        • Investigational Site Number 703004
      • Kosice, Slovakia, 04001
        • Investigational Site Number 703006
      • Levice, Slovakia, 93401
        • Investigational Site Number 703008
      • Martin, Slovakia, 03659
        • Investigational Site Number 703001
  • Sweden
      • Lund, Sweden, 22361
        • Investigational Site Number 752004
      • Malmö, Sweden, 21120
        • Investigational Site Number 752002
      • Skene, Sweden, 51162
        • Investigational Site Number 752003
      • Stockholm, Sweden, 17176
        • Investigational Site Number 752001
  • Switzerland
      • Geneve, Switzerland, 1205
        • Investigational Site Number 756001
  • Thailand
      • Bangkok, Thailand, 10400
        • Investigational Site Number 764001
      • Bangkok, Thailand, 10330
        • Investigational Site Number 764004
      • Chiangmai, Thailand, 50002
        • Investigational Site Number 764002
      • Khon Kaen, Thailand, 40002
        • Investigational Site Number 764003
      • Nakhonratchasima, Thailand, 30000
        • Investigational Site Number 764006
      • Pathumthani, Thailand, 12120
        • Investigational Site Number 764005
  • United Arab Emirates
      • Dubai, United Arab Emirates, 4545
        • Investigational Site Number 784-001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Insulin Glargine (HOE901) [Lantus]
100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
Drug: Glimepiride
tablets of 1 and 2 mg
Active Comparator: 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
Drug: Glimepiride
tablets of 1 and 2 mg
Drug: human insulin [NPH]
100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: Recorded at baseline (week 0), week 12, week 24 and week 36
Recorded at baseline (week 0), week 12, week 24 and week 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-monitored fasting plasma glucose (FPG)
Time Frame: Before baseline (week 0), weeks 12, 24 and 36
Before baseline (week 0), weeks 12, 24 and 36
8-points profiles
Time Frame: The week before baseline, at 12, 24 and 36 weeks
The week before baseline, at 12, 24 and 36 weeks
Episodes of hypoglycemia
Time Frame: From the week -2 to the week 36
From the week -2 to the week 36
Daily doses of insulin
Time Frame: 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
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
Time Frame: At week 24
At week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

August 21, 2012

Last Update Submitted That Met QC Criteria

August 20, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LANTU_C_02762
  • EUDRACT #: 2007-006640-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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