Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study
NCT ID: NCT01121835
Last Updated: 2013-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
934 participants
INTERVENTIONAL
2010-02-28
2012-03-31
Brief Summary
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To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.
Secondary Objectives:
To assess the effect of insulin glargine in comparison with premixed insulin on :
* Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c \< 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L)
* Percentage of patients who reach the target of HbA1c \< 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) \>Percentage of patients who reach the target of HbA1c \< 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) \>Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles
* Evolution of weight
* Hypoglycemia occurrence
* Dose of insulins
* Evolution of liver function
* Overall safety
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin glargine
Administered once a day in the evening, at the same time every day. The starting daily dose is 0.2 U/Kg of body weight or 12 U, at the investigator's decision.
Insulin glulisine is administered for patients of the insulin glargine group requiring insulin glulisine at week 12 (visit 11).
Insulin glulisine is administered prior (10-15 min) to the main meal of the day, which is the meal with highest Post-Prandial Plasma Glucose (PPPG) on the 3 profiles performed before week 12.
Starting dose is of 4 units per day.
INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL)
Premixed insulin
administered once a day (in the evening at dinner) or twice a day (in the morning before breakfast and in the evening at dinner). Starting daily dose will be 6 U at breakfast and 6 U at dinner, if administered twice a day or 12 U at dinner if administered once a day
PREMIXED INSULIN
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: - 30% soluble insulin aspart and 70 % protamine-crystallised insulin aspart in pre-filled Flexpen for all the countries except Mexico
* 25 % insulin lispro solution and 75% insulin lispro protamine in cartridges for Humapen Luxura for Mexico only
Interventions
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INSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL)
PREMIXED INSULIN
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: - 30% soluble insulin aspart and 70 % protamine-crystallised insulin aspart in pre-filled Flexpen for all the countries except Mexico
* 25 % insulin lispro solution and 75% insulin lispro protamine in cartridges for Humapen Luxura for Mexico only
Eligibility Criteria
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Inclusion Criteria
* Insulin naïve
* Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months
* HbA1c ≥ 7.0 % and ≤ 10.5%
* Body mass index (BMI) ≤ 40 kg/m2
* Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary
* Willingness and ability to comply with the study protocol
* Signed informed consent obtained prior any study procedure
Exclusion Criteria
* Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
* Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake)
* Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method)
* Hospitalized patient (except for routine diabetes check-up)
* Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry
* History of sensitivity to the study drugs or to drugs with a similar chemical structure
* Impaired renal function: creatinine clearance \< 60ml/min
* Impaired liver function (ALT, AST \> 3 x upper limit of normal range)
* Severe gastro-intestinal disease
* Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry
* Likelihood of requiring treatments during the study which are not permitted
* Treatment with an investigational product in the 30 days prior to study entry
* Alcohol or drug abuse within the last 5 years
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
35 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 040-004
Sankt Stefan, , Austria
Investigational Site Number 040-002
Vienna, , Austria
Investigational Site Number 040-001
Vienna, , Austria
Investigational Site Number 040-003
Vienna, , Austria
Investigational Site Number 076002
Belém, , Brazil
Investigational Site Number 076005
Curitiba, , Brazil
Investigational Site Number 076004
Fortaleza, , Brazil
Investigational Site Number 076001
Porto Alegre, , Brazil
Investigational Site Number 076003
São Paulo, , Brazil
Investigational Site Number 156004
Beijing, , China
Investigational Site Number 156005
Beijing, , China
Investigational Site Number 156006
Beijing, , China
Investigational Site Number 156011
Chongqing, , China
Investigational Site Number 156009
Dalian, , China
Investigational Site Number 156008
Guangzhou, , China
Investigational Site Number 156012
Haikou, , China
Investigational Site Number 156007
Nanjing, , China
Investigational Site Number 156001
Shanghai, , China
Investigational Site Number 156002
Shanghai, , China
Investigational Site Number 156003
Shanghai, , China
Investigational Site Number 156010
Shenyang, , China
Investigational Site Number 170001
Bogotá, , Colombia
Investigational Site Number 170002
Bogotá, , Colombia
Investigational Site Number 170003
Bucaramanga, , Colombia
Investigational Site Number 170005
Manizales, , Colombia
Investigational Site Number 170004
Pereira, , Colombia
Investigational Site Number 208-001
Hvidovre, , Denmark
Investigational Site Number 208-003
København NV, , Denmark
Investigational Site Number 208-002
København S, , Denmark
Investigational Site Number 300006
Alexandroupoli, , Greece
Investigational Site Number 300001
Athens, , Greece
Investigational Site Number 300002
Athens, , Greece
Investigational Site Number 300003
Athens, , Greece
Investigational Site Number 300004
Athens, , Greece
Investigational Site Number 300005
Irakleio, , Greece
Investigational Site Number 300011
Maroussi, Athens, , Greece
Investigational Site Number 300008
Thessaloniki, , Greece
Investigational Site Number 300010
Thessaloniki, , Greece
Investigational Site Number 300007
Thessaloniki, , Greece
Investigational Site Number 356008
Bangalore, , India
Investigational Site Number 356003
Bangalore, , India
Investigational Site Number 356007
Bangalore, , India
Investigational Site Number 356006
Bhubaneshwar, , India
Investigational Site Number 356001
Hyderabad, , India
Investigational Site Number 356005
Hyderabad, , India
Investigational Site Number 356004
Trivandrum, , India
Investigational Site Number 380-010
Catania, , Italy
Investigational Site Number 380-008
Catania, , Italy
Investigational Site Number 380-006
Colleferro, , Italy
Investigational Site Number 380-007
Foggia, , Italy
Investigational Site Number 380-005
Forlì, , Italy
Investigational Site Number 380-001
Genova, , Italy
Investigational Site Number 380-011
Merano, , Italy
Investigational Site Number 380-009
Napoli, , Italy
Investigational Site Number 380-012
Napoli, , Italy
Investigational Site Number 380-004
Parma, , Italy
Investigational Site Number 001
Kuwait City, , Kuwait
Investigational Site Number 484004
Aguascalientes, , Mexico
Investigational Site Number 484001
Aguascalientes, , Mexico
Investigational Site Number 484003
Guadalajara, , Mexico
Investigational Site Number 484002
Guadalajara, , Mexico
Investigational Site Number 484005
Puebla City, , Mexico
Investigational Site Number 642001
Iași, , Romania
Investigational Site Number 642002
Iași, , Romania
Investigational Site Number 642003
Oradea, , Romania
Investigational Site Number 410004
Ansan-si, Kyouggi-do, , South Korea
Investigational Site Number 410003
Koyang-si, , South Korea
Investigational Site Number 410001
Seoul, , South Korea
Investigational Site Number 410002
Seoul, , South Korea
Investigational Site Number 724001
Ávila, , Spain
Investigational Site Number 724002
Barcelona, , Spain
Investigational Site Number 724008
Galdakao, , Spain
Investigational Site Number 724007
Lugo, , Spain
Investigational Site Number 724004
Madrid, , Spain
Investigational Site Number 724009
Pamplona, , Spain
Investigational Site Number 724005
Santa Coloma de Gramanet, , Spain
Investigational Site Number 724003
Seville, , Spain
Investigational Site Number 724006
Valencia, , Spain
Investigational Site Number 158004
Changhua County, , Taiwan
Investigational Site Number 158007
Kaohsiung Hsien,, , Taiwan
Investigational Site Number 158006
New Taipei City, , Taiwan
Investigational Site Number 158001
Taichung, , Taiwan
Investigational Site Number 158009
Taichung, , Taiwan
Investigational Site Number 158005
Tainan City, , Taiwan
Investigational Site Number 158002
Taipei, , Taiwan
Investigational Site Number 158003
Xindian District, , Taiwan
Investigational Site Number 792-013
Ankara, , Turkey (Türkiye)
Investigational Site Number 792-009
Çanakkale, , Turkey (Türkiye)
Investigational Site Number 792-006
Diyarbakır, , Turkey (Türkiye)
Investigational Site Number 792-004
Istanbul, , Turkey (Türkiye)
Investigational Site Number 792-001
Izmir, , Turkey (Türkiye)
Investigational Site Number 792-016
Konya, , Turkey (Türkiye)
Investigational Site Number 792-007
Sivas, , Turkey (Türkiye)
Investigational Site Number 792-005
Trabzon, , Turkey (Türkiye)
Investigational Site Number 792-002
Van, , Turkey (Türkiye)
Investigational Site Number 784-001
Dubai, , United Arab Emirates
Countries
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Other Identifiers
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2009-018172-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1116-9859
Identifier Type: OTHER
Identifier Source: secondary_id
LANTU_C_04589
Identifier Type: -
Identifier Source: org_study_id
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