Recruitment

Recruitment Status
Completed
Estimated Enrollment
700

Inclusion Criteria

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 dipeptidyl-peptidase-4 inhibitor,
a sodium glucose co-transporter 2 inhibitor,
...
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 dipeptidyl-peptidase-4 inhibitor,
a sodium glucose co-transporter 2 inhibitor,
a glinide,
Treatment with basal insulin for at least 6 months before the screening visit.
Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.
metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
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 sulfonylurea,
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.
Signed written informed consent.

Exclusion Criteria

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).
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).
Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
Amylase and/or lipase more than 3 ULN .

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

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 dipeptidyl-peptidase-4 inhibitor,
a sodium glucose co-transporter 2 inhibitor,
...
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 dipeptidyl-peptidase-4 inhibitor,
a sodium glucose co-transporter 2 inhibitor,
a glinide,
Treatment with basal insulin for at least 6 months before the screening visit.
Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.
metformin (more than or equal to 1500 mg/day or maximal tolerated dose),
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 sulfonylurea,
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.
Signed written informed consent.

Exclusion Criteria

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).
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).
Average insulin glargine daily dose less than 20 Units or above 50 Units (in the week before randomization visit).
Amylase and/or lipase more than 3 ULN .

Tracking Information

NCT #
NCT02058160
Collaborators
Not Provided
Investigators
Study Director: Clinical Sciences & Operations Sanofi