Clinical trial NCT01121835: Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study
Official title: A 24-week, Open, Multicenter, Comparative Study of 2 Strategies (Including Insulin Glargine Versus Premixed Insulin) for the Therapeutic Management of Patients With Type 2 Diabetes Failing Oral Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 934
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

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


Eligibility criteria: Inclusion criteria:

* Type 2 diabetes diagnosed for more than 1 year
* 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:

* Treatment with glucagon-like peptide-1 (GLP-1) agonists in the 3 months prior to study entry
* 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.

Primary outcomes:
measure: Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]
timeFrame: From baseline (visit 2, week 0) to visit 14 (week 24)
Secondary outcomes:
measure: 7-point plasma glucose (PG) profile recorded on 3 consecutive days
timeFrame: From baseline (visit 2, week 0) to visit 14 (week 24)
measure: Self-monitored PG (Plasma Glucose) values over 3 consecutive days
timeFrame: before visit 4 (week 2)
measure: Self-monitored PG (Plasma Glucose) values over 3 consecutive days
timeFrame: before visit 8 (week 6)
measure: Self-monitored PG (Plasma Glucose) values over 3 consecutive days
timeFrame: before visit 12 (week 16)
measure: Weight and supine blood pressure
timeFrame: From baseline (visit 2, week 0) to visit 14 (week 24)
measure: Insulin doses of the day before each visit
timeFrame: from visit 3 (week 1) to visit 14 (week 24)
measure: Biochemistry and lipid profile
timeFrame: From baseline (visit 2, week 0) to visit 14 (week 24)
Other outcomes:
Locations:
city: Sankt Stefan
country: Austria
facility: Investigational Site Number 040-004
city: Vienna
country: Austria
facility: Investigational Site Number 040-002
city: Vienna
country: Austria
facility: Investigational Site Number 040-001
city: Vienna
country: Austria
facility: Investigational Site Number 040-003
city: Belém
country: Brazil
facility: Investigational Site Number 076002
city: Curitiba
country: Brazil
facility: Investigational Site Number 076005
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076004
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076001
city: São Paulo
country: Brazil
facility: Investigational Site Number 076003
city: Beijing
country: China
facility: Investigational Site Number 156004
city: Beijing
country: China
facility: Investigational Site Number 156005
city: Beijing
country: China
facility: Investigational Site Number 156006
city: Chongqing
country: China
facility: Investigational Site Number 156011
city: Dalian
country: China
facility: Investigational Site Number 156009
city: Guangzhou
country: China
facility: Investigational Site Number 156008
city: Haikou
country: China
facility: Investigational Site Number 156012
city: Nanjing
country: China
facility: Investigational Site Number 156007
city: Shanghai
country: China
facility: Investigational Site Number 156001
city: Shanghai
country: China
facility: Investigational Site Number 156002
city: Shanghai
country: China
facility: Investigational Site Number 156003
city: Shenyang
country: China
facility: Investigational Site Number 156010
city: Bogota
country: Colombia
facility: Investigational Site Number 170001
city: Bogota
country: Colombia
facility: Investigational Site Number 170002
city: Bucaramanga
country: Colombia
facility: Investigational Site Number 170003
city: Manizales
country: Colombia
facility: Investigational Site Number 170005
city: Pereira
country: Colombia
facility: Investigational Site Number 170004
city: Hvidovre
country: Denmark
facility: Investigational Site Number 208-001
city: København NV.
country: Denmark
facility: Investigational Site Number 208-003
city: København S.
country: Denmark
facility: Investigational Site Number 208-002
city: Alexandroupolis
country: Greece
facility: Investigational Site Number 300006
city: Athens
country: Greece
facility: Investigational Site Number 300001
city: Athens
country: Greece
facility: Investigational Site Number 300002
city: Athens
country: Greece
facility: Investigational Site Number 300003
city: Athens
country: Greece
facility: Investigational Site Number 300004
city: Iraklion
country: Greece
facility: Investigational Site Number 300005
city: Maroussi, Athens
country: Greece
facility: Investigational Site Number 300011
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300008
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300010
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300007
city: Bangalore
country: India
facility: Investigational Site Number 356008
city: Bangalore
country: India
facility: Investigational Site Number 356003
city: Bangalore
country: India
facility: Investigational Site Number 356007
city: Bhubaneshwar
country: India
facility: Investigational Site Number 356006
city: Hyderabad
country: India
facility: Investigational Site Number 356001
city: Hyderabad
country: India
facility: Investigational Site Number 356005
city: Trivandrum
country: India
facility: Investigational Site Number 356004
city: Catania
country: Italy
facility: Investigational Site Number 380-010
city: Catania
country: Italy
facility: Investigational Site Number 380-008
city: Colleferro
country: Italy
facility: Investigational Site Number 380-006
city: Foggia
country: Italy
facility: Investigational Site Number 380-007
city: Forlì
country: Italy
facility: Investigational Site Number 380-005
city: Genova
country: Italy
facility: Investigational Site Number 380-001
city: Merano
country: Italy
facility: Investigational Site Number 380-011
city: Napoli
country: Italy
facility: Investigational Site Number 380-009
city: Napoli
country: Italy
facility: Investigational Site Number 380-012
city: Parma
country: Italy
facility: Investigational Site Number 380-004
city: Ansan-si, Kyouggi-do
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Koyang-si
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Kuwait
country: Kuwait
facility: Investigational Site Number 001
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 484004
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 484001
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484003
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484002
city: Puebla
country: Mexico
facility: Investigational Site Number 484005
city: Iasi
country: Romania
facility: Investigational Site Number 642001
city: Iasi
country: Romania
facility: Investigational Site Number 642002
city: Oradea
country: Romania
facility: Investigational Site Number 642003
city: Avila
country: Spain
facility: Investigational Site Number 724001
city: Barcelona
country: Spain
facility: Investigational Site Number 724002
city: Galdakao
country: Spain
facility: Investigational Site Number 724008
city: Lugo
country: Spain
facility: Investigational Site Number 724007
city: Madrid
country: Spain
facility: Investigational Site Number 724004
city: Pamplona
country: Spain
facility: Investigational Site Number 724009
city: Santa Coloma de Gramanet
country: Spain
facility: Investigational Site Number 724005
city: Sevilla
country: Spain
facility: Investigational Site Number 724003
city: Valencia
country: Spain
facility: Investigational Site Number 724006
city: Changhua County
country: Taiwan
facility: Investigational Site Number 158004
city: Hsintien
country: Taiwan
facility: Investigational Site Number 158003
city: Kaohsiung Hsien,
country: Taiwan
facility: Investigational Site Number 158007
city: New Taipei city
country: Taiwan
facility: Investigational Site Number 158006
city: Taichung City
country: Taiwan
facility: Investigational Site Number 158009
city: Taichung
country: Taiwan
facility: Investigational Site Number 158001
city: Tainan
country: Taiwan
facility: Investigational Site Number 158005
city: Taipei
country: Taiwan
facility: Investigational Site Number 158002
city: Ankara
country: Turkey
facility: Investigational Site Number 792-013
city: Canakkale
country: Turkey
facility: Investigational Site Number 792-009
city: Diyarbakir
country: Turkey
facility: Investigational Site Number 792-006
city: Istanbul
country: Turkey
facility: Investigational Site Number 792-004
city: Izmir
country: Turkey
facility: Investigational Site Number 792-001
city: Konya
country: Turkey
facility: Investigational Site Number 792-016
city: Sivas
country: Turkey
facility: Investigational Site Number 792-007
city: Trabzon
country: Turkey
facility: Investigational Site Number 792-005
city: Van
country: Turkey
facility: Investigational Site Number 792-002
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 784-001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: