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 076-001
🇧🇷Fortaleza, Brazil
Investigational Site Number 076-006
🇧🇷Fortaleza, Brazil
Investigational Site Number 076-005
🇧🇷Porto Alegre, Brazil
Investigational Site Number 076-007
🇧🇷Rio de Janeiro, Brazil
Investigational Site Number 076-004
🇧🇷São Paulo, Brazil
Investigational Site Number 076-003
🇧🇷São Paulo, Brazil
Investigational Site Number 076-002
🇧🇷São Paulo, Brazil
Investigational Site Number 203003
🇨🇿Beroun, Czech Republic
Investigational Site Number 203008
🇨🇿Ceske Budejovice, Czech Republic
Investigational Site Number 203011
🇨🇿Ceske Budejovice, Czech Republic
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