Brief Summary
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
Brief Title
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
Categories
Completion Date
Completion Date Type
Actual
Conditions
Type 1 Diabetes Mellitus (T1DM)
High Level of Sugar (Glucose) in the Blood
Eligibility Criteria
Inclusion Criteria:
* Participants had given written informed consent to participate in the study in accordance with local regulations
* Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
* Participants were being treated with insulin or insulin analog
* Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
* At the Screening Visit, A1C was between 7.0% to 11.0%
* Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test
Exclusion Criteria:
* Use of antidiabetic agent other than insulin or insulin analog at the time of screening
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening
* Chronic systemic corticosteroid use
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator
* Participants had given written informed consent to participate in the study in accordance with local regulations
* Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
* Participants were being treated with insulin or insulin analog
* Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
* At the Screening Visit, A1C was between 7.0% to 11.0%
* Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test
Exclusion Criteria:
* Use of antidiabetic agent other than insulin or insulin analog at the time of screening
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening
* Chronic systemic corticosteroid use
* Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator
Inclusion Criteria
Inclusion Criteria:
* Participants had given written informed consent to participate in the study in accordance with local regulations
* Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
* Participants were being treated with insulin or insulin analog
* Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
* At the Screening Visit, A1C was between 7.0% to 11.0%
* Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test
* Participants had given written informed consent to participate in the study in accordance with local regulations
* Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
* Participants were being treated with insulin or insulin analog
* Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
* At the Screening Visit, A1C was between 7.0% to 11.0%
* Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02531035
Org Class
Industry
Org Full Name
Lexicon Pharmaceuticals
Org Study Id
LX4211.1-312-T1DM
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
Primary Outcomes
Outcome Description
The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \<7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.
Outcome Measure
Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization
Outcome Time Frame
Week 24
Secondary Ids
Secondary Id
LX4211.312
Secondary Outcomes
Outcome Description
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement.
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Change From Baseline in A1C
Outcome Description
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Absolute Change From Baseline in Body Weight
Outcome Description
An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16.
Outcome Time Frame
Baseline to Week 16
Outcome Measure
Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)
Outcome Description
The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24.
Outcome Time Frame
Baseline to Week 24
Outcome Measure
Percent Change From Baseline in Mean Daily Bolus Insulin Dose
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rubina Heptulla
Investigator Email
RHEPTULL@montefiore.org
Investigator Phone
718-920-6542 / 718-920-5473/ 718-920-4664