Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 700
Inclusion Criteria
- metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
- Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.
- a sulfonylurea,
- ...
- metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
- Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.
- a sulfonylurea,
- Signed written informed consent.
- Treatment with basal insulin for at least 6 months before the screening visit.
- Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit.
- Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.
- a glinide,
- Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.
- a dipeptidyl-peptidase-4 inhibitor,
- a sodium glucose co-transporter 2 inhibitor,
Exclusion Criteria
- Amylase and/or lipase more than 3 ULN .
- Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
- HbA1c less than 7% or above 10% .
- ...
- Amylase and/or lipase more than 3 ULN .
- Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
- HbA1c less than 7% or above 10% .
- Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).
Summary
- Conditions
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.
Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.
Inclusion Criteria
- metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
- Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.
- a sulfonylurea,
- ...
- metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
- Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40 Units/day for at least 2 months prior to the screening visit.
- a sulfonylurea,
- Signed written informed consent.
- Treatment with basal insulin for at least 6 months before the screening visit.
- Fasting Plasma Glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for participants receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for participants on basal insulin only or basal insulin plus metformin at screening visit.
- Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.
- a glinide,
- Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.
- a dipeptidyl-peptidase-4 inhibitor,
- a sodium glucose co-transporter 2 inhibitor,
Exclusion Criteria
- Amylase and/or lipase more than 3 ULN .
- Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
- HbA1c less than 7% or above 10% .
- ...
- Amylase and/or lipase more than 3 ULN .
- Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
- HbA1c less than 7% or above 10% .
- Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).
Tracking Information
- NCT #
- NCT02058160
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Sciences & Operations Sanofi