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Diabetes Mellitus, Type 2Phase 4LANCELOTNCT00949442

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

A Phase 4 study testing Insulin Glargine (HOE901) [Lantus], Glimepiride and human insulin [NPH] in people with Diabetes Mellitus, Type 2, run by Sanofi at 87 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin Glargine (HOE901) [Lantus], Glimepiride and human insulin [NPH]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
708 participants
Where
87 sitesin 17 countries
Study dates
Jul 2009to Jul 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

87 sites in 17 countries.

87 sites in 17 countries

Czechia11 sites

  • Investigational Site Number 203003

    Beroun, 26601

  • Investigational Site Number 203008

    České Budějovice, 37001

  • Investigational Site Number 203011

    České Budějovice, 37007

  • Investigational Site Number 203001

    Chrudim III, 53701

  • Investigational Site Number 203006

    Hodonín, 69501

  • Investigational Site Number 203002

    Hranice I - Mesto, 75301

  • Investigational Site Number 203010

    Liberec, 46001

  • Investigational Site Number 203009

    Moravský Písek, 39701

  • Investigational Site Number 203004

    Prague, 10000

  • Investigational Site Number 203005

    Prague, 10000

  • Investigational Site Number 203007

    Prague, 16300

Other trials in Czechia

Romania11 sites

  • Investigational Site Number 642001

    Bucharest

  • Investigational Site Number 642002

    Bucharest

  • Investigational Site Number 642009

    Cluj-Napoca

  • Investigational Site Number 642003

    Craiova

  • Investigational Site Number 642005

    Iași

  • Investigational Site Number 642010

    Oradea

  • Investigational Site Number 642011

    Oradea

  • Investigational Site Number 642007

    Ploieşti

  • Investigational Site Number 642004

    Reşiţa

  • Investigational Site Number 642008

    Târgu Mureş

  • Investigational Site Number 642012

    Timișoara

Other trials in Romania

Slovakia8 sites

  • Investigational Site Number 703005

    Banská Bystrica, 97517

  • Investigational Site Number 703003

    Bratislava, 81102

  • Investigational Site Number 703007

    Bratislava, 82606

  • Investigational Site Number 703004

    Košice, 04001

  • Investigational Site Number 703006

    Košice, 04001

  • Investigational Site Number 703002

    Košice, 04011

  • Investigational Site Number 703008

    Levice, 93401

  • Investigational Site Number 703001

    Martin, 03659

Other trials in Slovakia

Brazil7 sites

  • Investigational Site Number 076-001

    Fortaleza, 60115-282

  • Investigational Site Number 076-006

    Fortaleza, 60430-370

  • Investigational Site Number 076-005

    Porto Alegre, 90035-170

  • Investigational Site Number 076-007

    Rio de Janeiro, 202110340

  • Investigational Site Number 076-004

    São Paulo, 01221-000

  • Investigational Site Number 076-003

    São Paulo, 01244-030

  • Investigational Site Number 076-002

    São Paulo, 04024-002

Other trials in Brazil

Russia7 sites

  • Investigational Site Number 643-001

    Moscow

  • Investigational Site Number 643-002

    Saint Petersburg, 195257

  • Investigational Site Number 643-003

    Saint Petersburg

  • Investigational Site Number 643-006

    Samara

  • Investigational Site Number 643-005

    Saratov

  • Investigational Site Number 643-004

    St-Ptetersburg, 194354

  • Investigational Site Number 643-007

    Tyumen, 625046

Other trials in Russia

France6 sites

  • Investigational Site Number 250-002

    Aix-en-Provence, 13100

  • Investigational Site Number 250-001

    Antibes, 06600

  • Investigational Site Number 250-005

    Bordeaux, 33200

  • Investigational Site Number 250-004

    Jarny, 54800

  • Investigational Site Number 250-003

    Narbonne, 11018

  • Investigational Site Number 250-006

    Strasbourg, 67000

Other trials in France

Mexico6 sites

  • Investigational Site Number 484003

    Guadalajara, 44150

  • Investigational Site Number 484005

    Guadalajara, 44650

  • Investigational Site Number 484001

    Monterrey, 64710

  • Investigational Site Number 484008

    Pachuca, 042090

  • Investigational Site Number 484009

    Pachuca, 42086

  • Investigational Site Number 484002

    Puebla City, 72190

Other trials in Mexico

Netherlands6 sites

  • Investigational Site Number 528006

    Almelo, 7600SZ

  • Investigational Site Number 528005

    Apeldoorn, 7314 ET

  • Investigational Site Number 528001

    Beek, 6191JW

  • Investigational Site Number 528002

    Hoogeveen, 7909AA

  • Investigational Site Number 528004

    Hoogezand, 9603AE

  • Investigational Site Number 528003

    Rotterdam, 3053CD

Other trials in Netherlands

South Korea6 sites

  • Investigational Site Number 410005

    Daegu

  • Investigational Site Number 410002

    Gyeonggi-do, 420-717

  • Investigational Site Number 410006

    Incheon, 400-711

  • Investigational Site Number 410001

    Seoul, 137-701

  • Investigational Site Number 410003

    Seoul

  • Investigational Site Number 410004

    Seoul

Other trials in South Korea

Thailand6 sites

  • Investigational Site Number 764004

    Bangkok, 10330

  • Investigational Site Number 764001

    Bangkok, 10400

  • Investigational Site Number 764002

    Chiang Mai, 50002

  • Investigational Site Number 764003

    Khon Kaen, 40002

  • Investigational Site Number 764006

    Nakhonratchasima, 30000

  • Investigational Site Number 764005

    Pathum Thani, 12120

Other trials in Thailand

Poland4 sites

  • Investigational Site Number 616004

    Gdansk, 80-211

  • Investigational Site Number 616003

    Krakow, 31-262

  • Investigational Site Number 616002

    Lublin, 20-954

  • Investigational Site Number 616001

    Zabrze, 41-800

Other trials in Poland

Sweden4 sites

  • Investigational Site Number 752004

    Lund, 22361

  • Investigational Site Number 752002

    Malmö, 21120

  • Investigational Site Number 752003

    Skene, 51162

  • Investigational Site Number 752001

    Stockholm, 17176

Other trials in Sweden

Egypt1 site

  • Investigational Site Number 818001

    Menoufiya

Other trials in Egypt

Italy1 site

  • Investigational Site Number 380001

    Perugia, 06156

Other trials in Italy

Kuwait1 site

  • Investigational Site Number 414001

    Kuwait City

Other trials in Kuwait

Switzerland1 site

  • Investigational Site Number 756001

    Geneva, 1205

Other trials in Switzerland

United Arab Emirates1 site

  • Investigational Site Number 784-001

    Dubai, 4545

Other trials in United Arab Emirates

About this study

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

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.

Read more

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).
Being tested
Insulin Glargine (HOE901) [Lantus], Glimepiride, human insulin [NPH]
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin Glargine (HOE901) [Lantus]Drug

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

  • GlimepirideDrug

    tablets of 1 and 2 mg

  • human insulin [NPH]Drug

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

Study groups in NCT00949442
Study groupRoleWhat they receive
1ExperimentalBefore 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
Receives: Drug: Insulin Glargine (HOE901) [Lantus]; Drug: Glimepiride
2Active comparatorBefore 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
Receives: Drug: Glimepiride; Drug: human insulin [NPH]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

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

Secondary outcomes (5)

  1. Self-monitored fasting plasma glucose (FPG)

    Measured: Before baseline (week 0), weeks 12, 24 and 36

  2. 8-points profiles

    Measured: The week before baseline, at 12, 24 and 36 weeks

  3. Episodes of hypoglycemia

    Measured: From the week -2 to the week 36

  4. Daily doses of insulin

    Measured: 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

  5. Need of additional prandial insulin

    Measured: At week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00949442
Sponsor's protocol ID
LANTU_C_02762
Other IDs
EUDRACT #: 2007-006640-22
Acronym
LANCELOT
Status last verified
Aug 2012
First submitted
27 Jul 2009
Last updated
21 Aug 2012
Results posted
No

Publications

  • 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.

    PubMed 33166419

  • 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.

    PubMed 24957785

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin Glargine (HOE901) [Lantus], Glimepiride and human insulin [NPH] in people with Diabetes Mellitus, Type 2, run by Sanofi at 87 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Czechia, Romania, Slovakia, Brazil, Russia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Recorded at baseline (week 0), week 12, week 24 and week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00949442, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.

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