Clinical trial NCT03066830: Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea Alone or in Combination With Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2017-02-28
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin.

Secondary Objectives:

* To compare Sotagliflozin 400 mg versus placebo based on:
* Change from baseline in fasting plasma glucose (FPG).
* Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mm Hg).
* Change from baseline in SBP for all participants.
* Change from baseline in body weight.
* Percentage of participants with HbA1c \<6.5% and \<7.0%.
* To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Detailed description: The duration per participants is up to 85 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2-week single-blind Run-in phase, a 26-week double blind Core Treatment Period, a 53 week double blind Extension, and a 2-week post treatment Follow-up period to collect safety information.

Eligibility criteria: Inclusion criteria :

* Participants with T2D treated with a Sulfonylurea (≥half the maximum recommended dose as per local label or maximum tolerated dose \[documented\]) as monotherapy or in combination with Metformin (≥1500 mg per day or maximum tolerated dose \[documented\]) each at a stable dose for at least 12 weeks without a dose adjustment before screening.
* Signed written informed consent.

Exclusion criteria:

* At the time of screening, age \<18 years or \< legal age of majority, whichever is greater.
* Body Mass Index (BMI) ≤20 or \>45 kilograms per meter square (kg/m\^2) at Screening.
* Hemoglobin A1c (HbA1c) \<7% or HbA1c \>10% via central lab test at screening.
* Fasting plasma glucose (FPG) \>15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (\>15 mmol/L \[270 mg/dL\]) by a repeat test before randomization.
* Women of childbearing potential with no effective contraceptive method.
* Treated with an antidiabetic pharmacological regimen other than a Sulfonylurea at a stable dose with or without Metformin within 12 weeks preceding the screening visit.
* Previous insulin use \>1 month (at any time, aside from treatment of gestational diabetes).
* History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
* History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
* History of severe hypoglycemia within 6 months prior to the Screening visit.
* Systolic blood pressure (SBP) \>180 millimeter per mercury (mmHg) or diastolic blood pressure (DBP) \>100 mmHg or history of hypertensive emergency.
* Aspartate aminotransferase and/or alanine aminotransferase: \>3 times the upper limit of the normal laboratory range (ULN).
* Total bilirubin: \>1.5 times ULN (except in case of Gilbert's syndrome).
* Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
* Pregnancy, breastfeeding.
* Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the participant's diary as required per protocol.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: Baseline to Week 26
measure: Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg
timeFrame: Baseline to Week 12
measure: Change From Baseline in SBP at Week 12 for All Participants
timeFrame: Baseline to Week 12
measure: Change From Baseline in Body Weight at Week 26
timeFrame: Baseline to Week 26
measure: Percentage of Participants With HbA1c <6.5% at Week 26
timeFrame: Week 26
measure: Percentage of Participants With HbA1c <7.0% at Week 26
timeFrame: Week 26
Other outcomes:
measure: Percentage of Participants With Hypoglycemic Events
timeFrame: Up to 79 weeks in the treatment period
Locations:
city: Litchfield Park
country: United States
facility: Investigational Site Number 8403003
state: Arizona
city: Peoria
country: United States
facility: Investigational Site Number 8403018
state: Arizona
city: Greenbrae
country: United States
facility: Investigational Site Number 8403009
state: California
city: Huntington Park
country: United States
facility: Investigational Site Number 8403012
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8403019
state: California
city: Montclair
country: United States
facility: Investigational Site Number 8403034
state: California
city: Spring Valley
country: United States
facility: Investigational Site Number 8403016
state: California
city: Tustin
country: United States
facility: Investigational Site Number 8403014
state: California
city: Northglenn
country: United States
facility: Investigational Site Number 8403001
state: Colorado
city: Bradenton
country: United States
facility: Investigational Site Number 8403029
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 8403004
state: Florida
city: North Miami Beach
country: United States
facility: Investigational Site Number 8403020
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 8403026
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 8403032
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 8403008
state: Florida
city: Pembroke Pines
country: United States
facility: Investigational Site Number 8403006
state: Florida
city: Port Charlotte
country: United States
facility: Investigational Site Number 8403013
state: Florida
city: Nampa
country: United States
facility: Investigational Site Number 8403007
state: Idaho
city: Flint
country: United States
facility: Investigational Site Number 8403011
state: Michigan
city: Richfield
country: United States
facility: Investigational Site Number 8403025
state: Minnesota
city: Henderson
country: United States
facility: Investigational Site Number 8403021
state: Nevada
city: Greensboro
country: United States
facility: Investigational Site Number 8403028
state: North Carolina
city: Shelby
country: United States
facility: Investigational Site Number 8403015
state: North Carolina
city: Hatboro
country: United States
facility: Investigational Site Number 8403033
state: Pennsylvania
city: Kingsport
country: United States
facility: Investigational Site Number 8403030
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site Number 8403002
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 8403022
state: Texas
city: Burke
country: United States
facility: Investigational Site Number 8403005
state: Virginia
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number 1003003
city: Ruse
country: Bulgaria
facility: Investigational Site Number 1003002
city: Sofia
country: Bulgaria
facility: Investigational Site Number 1003004
city: Parnu
country: Estonia
facility: Investigational Site Number 2333003
city: Balatonfüred
country: Hungary
facility: Investigational Site Number 3483001
city: Budapest
country: Hungary
facility: Investigational Site Number 3483007
city: Budapest
country: Hungary
facility: Investigational Site Number 3483008
city: Budapest
country: Hungary
facility: Investigational Site Number 3483010
city: Budapest
country: Hungary
facility: Investigational Site Number 3483004
city: Budapest
country: Hungary
facility: Investigational Site Number 3483006
city: Gyula
country: Hungary
facility: Investigational Site Number 3483011
city: Hatvan
country: Hungary
facility: Investigational Site Number 3483009
city: Kecskemet
country: Hungary
facility: Investigational Site Number 3483005
city: Pécs
country: Hungary
facility: Investigational Site Number 3483003
city: Zalaegerszeg
country: Hungary
facility: Investigational Site Number 3483012
city: Goyang-Si, Gyeonggi-Do
country: Korea, Republic of
facility: Investigational Site Number 4103001
city: Guri-Si, Gyeonggi-Do
country: Korea, Republic of
facility: Investigational Site Number 4103011
city: Seongnam-Si, Gyeonggi-Do
country: Korea, Republic of
facility: Investigational Site Number 4103003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4103007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4103006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4103010
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 4103005
city: Wonju-Si, Gangwon-Do
country: Korea, Republic of
facility: Investigational Site Number 4103009
city: Gdansk
country: Poland
facility: Investigational Site Number 6163005
city: Gdynia
country: Poland
facility: Investigational Site Number 6163006
city: Katowice
country: Poland
facility: Investigational Site Number 6163003
city: Poznan
country: Poland
facility: Investigational Site Number 6163002
city: Warszawa
country: Poland
facility: Investigational Site Number 6163001
city: Wroclaw
country: Poland
facility: Investigational Site Number 6163004
city: Bucuresti
country: Romania
facility: Investigational Site Number 6423004
city: Iasi
country: Romania
facility: Investigational Site Number 6423002
city: Bratislava
country: Slovakia
facility: Investigational Site Number 7033006
city: Bratislava
country: Slovakia
facility: Investigational Site Number 7033001
city: Bratislava
country: Slovakia
facility: Investigational Site Number 7033002
city: Malacky
country: Slovakia
facility: Investigational Site Number 7033004
city: Sturovo
country: Slovakia
facility: Investigational Site Number 7033003
city: Trencin
country: Slovakia
facility: Investigational Site Number 7033007
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8043001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8043003
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8043002
city: Birmingham
country: United Kingdom
facility: Investigational Site Number 8263012
city: Cardiff
country: United Kingdom
facility: Investigational Site Number 8263009
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 8263007
city: Hexham
country: United Kingdom
facility: Investigational Site Number 8263008
city: Inverness
country: United Kingdom
facility: Investigational Site Number 8263003
city: Liverpool
country: United Kingdom
facility: Investigational Site Number 8263014
city: Manchester
country: United Kingdom
facility: Investigational Site Number 8263011
city: Reading
country: United Kingdom
facility: Investigational Site Number 8263010
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason
role: STUDY_DIRECTOR
References: