Efficacy and Safety of Sotagliflozin versus Placebo in Patients with Type 2 Diabetes Mellitus on Background of Sulfonylurea alone or with Metformin

• Register: EUCTR
• Last refreshed on: 18 March 2020
• Main ID: EUCTR2016-002826-35-SK
• Date of registration: 20/02/2017
• Prospective Registration: Yes
• Primary sponsor: Lexicon Pharmaceuticals, Inc.
• Public title: Efficacy and Safety of Sotagliflozin versus Placebo in Patients with Type 2 Diabetes Mellitus on Background of Sulfonylurea alone or with Metformin
• Scientific 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
• Date of first enrolment: 16/03/2017
• Target sample size: 625
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002826-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Estonia, Hungary, Korea, Republic of, Poland, Romania, Slovakia, Ukraine, United Kingdom, United States

Contacts

• Name: Executive Director, Clinical Ops
• Affiliation: Lexicon Pharmaceuticals, Inc.

• Name: Executive Director, Clinical Ops
• Affiliation: Lexicon Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
-Patients 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 enrollment.
-Signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 469
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 156

Exclusion criteria:
-At the time of screening age <18 years.
-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 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.
-Patient is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the patient’s
diary as required per protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 diabetes mellitus
MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: Sotagliflozin
Product Code: SAR439954
Pharmaceutical Form: Tablet
INN or Proposed INN: SOTAGLIFLOZIN
Current Sponsor code: SAR439954
Other descriptive name: LX4211, LX-4211, LP-802034
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To demonstrate the superiority of sotagliflozin 400 mg versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in patients with type 2 diabetes (T2D) who have inadequate glycemic control with a sulfonylurea alone or in combination with metformin

Primary end point(s): Change from baseline in HbA1c

Secondary Objective: -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 patients with baseline SBP =130 mm Hg.
-Change from baseline in SBP for all patients.
-Change from baseline in body weight.
-Proportion of patients with HbA1c <6.5% and <7.0%.
-To evaluate the safety of sotagliflozin 400 mg versus placebo throughout the 79 -week trial.

Timepoint(s) of evaluation of this end point: Baseline to Week 26

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1- Change from baseline in FPG : Baseline to Week 26
2- Change from baseline in SBP for patients with baseline SBP =130 mmHg : Baseline to Week 12
3- Change from baseline in SBP for all patients : Baseline to Week 12
4- Change from baseline in body weight : Baseline to Week 26
5- Percentage of patients with HbA1c <6.5% : At Week 26
6- Percentage of patients with HbA1c <7.0% : At Week 26
7- Measurement of bone metabolism markers : Baseline to Week 79
8- Measurement of calcium metabolism markers : Baseline to Week 79
9- Measurement of intestinal transit markers : Baseline to Week 79
10- Measurement of intestinal absorption markers : Baseline to Week 79

Secondary end point(s): 1- Change from baseline in FPG
2- Change from baseline in SBP for patients with baseline SBP =130 mmHg
3- Change from baseline in SBP for all patients
4- Change from baseline in body weight
5- Percentage of patients with HbA1c <6.5%
6- Percentage of patients with HbA1c <7.0%
7- Measurement of bone metabolism markers
8- Measurement of calcium metabolism markers
9- Measurement of intestinal transit markers
10- Measurement of intestinal absorption markers

Secondary ID(s)

EFC14835

2016-002826-35-EE

Source(s) of Monetary Support

Lexicon Pharmaceuticals, Inc.

Ethics review

Status: Approved
Approval date: 07/03/2017
Contact: