Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01121835
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 934
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin glargine INSULIN GLULISINE 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. Premixed insulin 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 Insulin glargine 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.
- Primary Outcome Measures
Name Time Method 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] From baseline (visit 2, week 0) to visit 14 (week 24)
- Secondary Outcome Measures
Name Time Method Self-monitored PG (Plasma Glucose) values over 3 consecutive days before visit 12 (week 16) 7-point plasma glucose (PG) profile recorded on 3 consecutive days From baseline (visit 2, week 0) to visit 14 (week 24) Insulin doses of the day before each visit from visit 3 (week 1) to visit 14 (week 24) Weight and supine blood pressure From baseline (visit 2, week 0) to visit 14 (week 24) Biochemistry and lipid profile From baseline (visit 2, week 0) to visit 14 (week 24)
Trial Locations
- Locations (96)
Investigational Site Number 170003
🇨🇴Bucaramanga, Colombia
Investigational Site Number 170004
🇨🇴Pereira, Colombia
Investigational Site Number 156012
🇨🇳Haikou, China
Investigational Site Number 076004
🇧🇷Fortaleza, Brazil
Investigational Site Number 170002
🇨🇴Bogota, Colombia
Investigational Site Number 300002
🇬🇷Athens, Greece
Investigational Site Number 300007
🇬🇷Thessaloniki, Greece
Investigational Site Number 076001
🇧🇷Porto Alegre, Brazil
Investigational Site Number 170001
🇨🇴Bogota, Colombia
Investigational Site Number 300006
🇬🇷Alexandroupolis, Greece
Investigational Site Number 156004
🇨🇳Beijing, China
Investigational Site Number 076002
🇧🇷Belém, Brazil
Investigational Site Number 356006
🇮🇳Bhubaneshwar, India
Investigational Site Number 076003
🇧🇷São Paulo, Brazil
Investigational Site Number 156005
🇨🇳Beijing, China
Investigational Site Number 170005
🇨🇴Manizales, Colombia
Investigational Site Number 300001
🇬🇷Athens, Greece
Investigational Site Number 300011
🇬🇷Maroussi, Athens, Greece
Investigational Site Number 001
🇰🇼Kuwait, Kuwait
Investigational Site Number 484004
🇲🇽Aguascalientes, Mexico
Investigational Site Number 484002
🇲🇽Guadalajara, Mexico
Investigational Site Number 484001
🇲🇽Aguascalientes, Mexico
Investigational Site Number 484003
🇲🇽Guadalajara, Mexico
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 076005
🇧🇷Curitiba, Brazil
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 156001
🇨🇳Shanghai, China
Investigational Site Number 156002
🇨🇳Shanghai, China
Investigational Site Number 156003
🇨🇳Shanghai, China
Investigational Site Number 156010
🇨🇳Shenyang, China
Investigational Site Number 300003
🇬🇷Athens, Greece
Investigational Site Number 300004
🇬🇷Athens, Greece
Investigational Site Number 642001
🇷🇴Iasi, Romania
Investigational Site Number 300010
🇬🇷Thessaloniki, Greece
Investigational Site Number 300005
🇬🇷Iraklion, Greece
Investigational Site Number 300008
🇬🇷Thessaloniki, Greece
Investigational Site Number 356008
🇮🇳Bangalore, India
Investigational Site Number 356003
🇮🇳Bangalore, India
Investigational Site Number 356007
🇮🇳Bangalore, 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 380-001
🇮🇹Genova, Italy
Investigational Site Number 380-009
🇮🇹Napoli, Italy
Investigational Site Number 410004
🇰🇷Ansan-si, Kyouggi-do, Korea, Republic of
Investigational Site Number 410003
🇰🇷Koyang-si, Korea, Republic of
Investigational Site Number 410001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 484005
🇲🇽Puebla, Mexico
Investigational Site Number 642002
🇷🇴Iasi, Romania
Investigational Site Number 642003
🇷🇴Oradea, Romania
Investigational Site Number 724001
🇪🇸Avila, Spain
Investigational Site Number 724002
🇪🇸Barcelona, Spain
Investigational Site Number 724008
🇪🇸Galdakao, Spain
Investigational Site Number 724004
🇪🇸Madrid, Spain
Investigational Site Number 724007
🇪🇸Lugo, Spain
Investigational Site Number 724009
🇪🇸Pamplona, Spain
Investigational Site Number 724005
🇪🇸Santa Coloma de Gramanet, Spain
Investigational Site Number 724003
🇪🇸Sevilla, Spain
Investigational Site Number 724006
🇪🇸Valencia, Spain
Investigational Site Number 158004
🇨🇳Changhua County, Taiwan
Investigational Site Number 158003
🇨🇳Hsintien, Taiwan
Investigational Site Number 158007
🇨🇳Kaohsiung Hsien,, Taiwan
Investigational Site Number 158006
🇨🇳New Taipei city, Taiwan
Investigational Site Number 158009
🇨🇳Taichung City, Taiwan
Investigational Site Number 158001
🇨🇳Taichung, Taiwan
Investigational Site Number 158005
🇨🇳Tainan, Taiwan
Investigational Site Number 158002
🇨🇳Taipei, Taiwan
Investigational Site Number 792-013
🇹🇷Ankara, Turkey
Investigational Site Number 792-009
🇹🇷Canakkale, Turkey
Investigational Site Number 792-006
🇹🇷Diyarbakir, Turkey
Investigational Site Number 792-004
🇹🇷Istanbul, Turkey
Investigational Site Number 792-001
🇹🇷Izmir, Turkey
Investigational Site Number 792-016
🇹🇷Konya, Turkey
Investigational Site Number 792-007
🇹🇷Sivas, Turkey
Investigational Site Number 792-002
🇹🇷Van, Turkey
Investigational Site Number 784-001
🇦🇪Dubai, United Arab Emirates
Investigational Site Number 792-005
🇹🇷Trabzon, Turkey
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 380-011
🇮🇹Merano, Italy
Investigational Site Number 380-012
🇮🇹Napoli, Italy
Investigational Site Number 380-004
🇮🇹Parma, Italy
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 040-003
🇦🇹Vienna, Austria
Investigational Site Number 156007
🇨🇳Nanjing, China