Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00949442
- Lead Sponsor
- Sanofi
- Brief 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.
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 708
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Insulin Glargine (HOE901) [Lantus] 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 1 Glimepiride 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 2 Glimepiride 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 2 human insulin [NPH] 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
- Primary Outcome Measures
Name Time Method HbA1c Recorded at baseline (week 0), week 12, week 24 and week 36
- Secondary Outcome Measures
Name Time Method Self-monitored fasting plasma glucose (FPG) Before baseline (week 0), weeks 12, 24 and 36 8-points profiles The week before baseline, at 12, 24 and 36 weeks Episodes of hypoglycemia From the week -2 to the week 36 Daily doses of insulin 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 At week 24
Trial Locations
- Locations (87)
Investigational Site Number 414001
🇰🇼Kuwait, Kuwait
Investigational Site Number 642005
🇷🇴Iasi, Romania
Investigational Site Number 642010
🇷🇴Oradea, Romania
Investigational Site Number 642008
🇷🇴Targu-Mures, Romania
Investigational Site Number 643-002
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 703004
🇸🇰Kosice, Slovakia
Investigational Site Number 643-001
🇷🇺Moscow, Russian Federation
Investigational Site Number 484003
🇲🇽Guadalajara, Mexico
Investigational Site Number 616001
🇵🇱Zabrze, Poland
Investigational Site Number 642001
🇷🇴Bucharest, Romania
Investigational Site Number 642002
🇷🇴Bucharest, Romania
Investigational Site Number 642012
🇷🇴Timisoara, Romania
Investigational Site Number 616003
🇵🇱Kraków, Poland
Investigational Site Number 616002
🇵🇱Lublin, Poland
Investigational Site Number 642004
🇷🇴Resita, Romania
Investigational Site Number 643-005
🇷🇺Saratov, Russian Federation
Investigational Site Number 528003
🇳🇱Rotterdam, Netherlands
Investigational Site Number 616004
🇵🇱Gdansk, Poland
Investigational Site Number 643-006
🇷🇺Samara, Russian Federation
Investigational Site Number 703005
🇸🇰Banská Bystrica, Slovakia
Investigational Site Number 703002
🇸🇰Kosice, Slovakia
Investigational Site Number 703008
🇸🇰Levice, Slovakia
Investigational Site Number 643-003
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 703006
🇸🇰Kosice, Slovakia
Investigational Site Number 076-005
🇧🇷Porto Alegre, Brazil
Investigational Site Number 076-001
🇧🇷Fortaleza, Brazil
Investigational Site Number 410001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 076-004
🇧🇷São Paulo, Brazil
Investigational Site Number 410004
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 203006
🇨🇿Hodonin, Czech Republic
Investigational Site Number 484005
🇲🇽Guadalajara, Mexico
Investigational Site Number 484001
🇲🇽Monterrey, Mexico
Investigational Site Number 076-002
🇧🇷São Paulo, Brazil
Investigational Site Number 484008
🇲🇽Pachuca, Mexico
Investigational Site Number 410003
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 484009
🇲🇽Pachuca, Mexico
Investigational Site Number 484002
🇲🇽Puebla, Mexico
Investigational Site Number 528006
🇳🇱Almelo, Netherlands
Investigational Site Number 528005
🇳🇱Apeldoorn, Netherlands
Investigational Site Number 528001
🇳🇱Beek, Netherlands
Investigational Site Number 528004
🇳🇱Hoogezand, Netherlands
Investigational Site Number 642011
🇷🇴Oradea, Romania
Investigational Site Number 642007
🇷🇴Ploiesti, Romania
Investigational Site Number 703003
🇸🇰Bratislava, Slovakia
Investigational Site Number 703007
🇸🇰Bratislava, Slovakia
Investigational Site Number 752002
🇸🇪Malmö, Sweden
Investigational Site Number 752003
🇸🇪Skene, Sweden
Investigational Site Number 764001
🇹🇭Bangkok, Thailand
Investigational Site Number 764002
🇹🇭Chiangmai, Thailand
Investigational Site Number 764006
🇹🇭Nakhonratchasima, Thailand
Investigational Site Number 076-006
🇧🇷Fortaleza, Brazil
Investigational Site Number 076-003
🇧🇷São Paulo, Brazil
Investigational Site Number 076-007
🇧🇷Rio de Janeiro, Brazil
Investigational Site Number 203008
🇨🇿Ceske Budejovice, Czech Republic
Investigational Site Number 203011
🇨🇿Ceske Budejovice, Czech Republic
Investigational Site Number 203003
🇨🇿Beroun, Czech Republic
Investigational Site Number 203001
🇨🇿Chrudim III, Czech Republic
Investigational Site Number 203002
🇨🇿Hranice I - Mesto, Czech Republic
Investigational Site Number 203010
🇨🇿Liberec, Czech Republic
Investigational Site Number 203009
🇨🇿Moravsky Pisek, Czech Republic
Investigational Site Number 203004
🇨🇿Praha 10, Czech Republic
Investigational Site Number 203005
🇨🇿Praha 10, Czech Republic
Investigational Site Number 203007
🇨🇿Praha 6, Czech Republic
Investigational Site Number 818001
🇪🇬Menoufiya, Egypt
Investigational Site Number 250-002
🇫🇷Aix En Provence, France
Investigational Site Number 250-001
🇫🇷Antibes, France
Investigational Site Number 250-005
🇫🇷Bordeaux, France
Investigational Site Number 250-006
🇫🇷Strasbourg, France
Investigational Site Number 250-004
🇫🇷Jarny, France
Investigational Site Number 410005
🇰🇷Daegu, Korea, Republic of
Investigational Site Number 250-003
🇫🇷NARBONNE Cedex, France
Investigational Site Number 410006
🇰🇷Incheon, Korea, Republic of
Investigational Site Number 380001
🇮🇹Perugia, Italy
Investigational Site Number 410002
🇰🇷Gyeonggi-Do, Korea, Republic of
Investigational Site Number 528002
🇳🇱Hoogeveen, Netherlands
Investigational Site Number 642009
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 642003
🇷🇴Craiova, Romania
Investigational Site Number 643-004
🇷🇺St-Ptetersburg, Russian Federation
Investigational Site Number 643-007
🇷🇺Tyumen, Russian Federation
Investigational Site Number 703001
🇸🇰Martin, Slovakia
Investigational Site Number 752004
🇸🇪Lund, Sweden
Investigational Site Number 764004
🇹🇭Bangkok, Thailand
Investigational Site Number 752001
🇸🇪Stockholm, Sweden
Investigational Site Number 756001
🇨🇭Geneve, Switzerland
Investigational Site Number 764003
🇹🇭Khon Kaen, Thailand
Investigational Site Number 764005
🇹🇭Pathumthani, Thailand
Investigational Site Number 784-001
🇦🇪Dubai, United Arab Emirates