Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03332771
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
Primary Objective:
To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin.
Secondary Objectives:
To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter \[mg/dL\]).
* To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants.
* To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c.
* To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
* To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
* To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.
- Detailed Description
Up to 58 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks, a 2-week single-blind placebo Run-in phase, a 52-week double-blind Treatment Period, and a 2-week post-treatment Follow-up period to collect safety information.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 954
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sotagliflozin 400 mg Placebo Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Sotagliflozin 200 mg Placebo Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Sotagliflozin 400 mg Sotagliflozin (SAR439954) Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Sotagliflozin 200 mg Sotagliflozin (SAR439954) Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Glimepiride Placebo Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Placebo Placebo Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Sotagliflozin 400 mg Metformin Following a 2-week run-in period, two Sotagliflozin 200 mg, tablets, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Sotagliflozin 200 mg Metformin Following a 2-week run-in period, one Sotagliflozin 200 mg, tablet and one Sotagliflozin-matching placebo tablet, and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Glimepiride Metformin Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Glimepiride Glimepiride Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets, and combination of two Glimepiride capsules with adequate dose strengths per dose titration (titrated up to 6mg), taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks. Placebo Metformin Following a 2-week run-in period, two Sotagliflozin-matching placebo tablets and two Glimepiride-matching placebo capsules, taken orally once daily before the first meal of the day in the double-blind treatment period up to 52 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c at Week 52 Baseline, Week 52 An analysis of covariance (ANCOVA) model was used for the analysis.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12 Baseline, Week 12 An ANCOVA model was used for the analysis.
Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event Up to Week 52 Documented symptomatic hypoglycemia includes the typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L).
Change From Baseline in Hemoglobin A1c at Week 26 Baseline, Week 26 An ANCOVA model was used for the analysis.
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12 Baseline, Week 12 An ANCOVA model was used for the analysis.
Change From Baseline in Body Weight at Week 26 and 52 Baseline, Week 26, Week 52 An ANCOVA model was used for the analysis.
Percentage of Participants With Adverse Events (AEs) Up to Week 52 An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Trial Locations
- Locations (142)
Investigational Site Number 8407074
🇺🇸Bradenton, Florida, United States
Investigational Site Number 8407111
🇺🇸Dallas, Texas, United States
Investigational Site Number 8407078
🇺🇸Carmichael, California, United States
Investigational Site Number 8407019
🇺🇸Los Angeles, California, United States
Investigational Site Number 8407006
🇺🇸Huntington Park, California, United States
Investigational Site Number 8407065
🇺🇸Canoga Park, California, United States
Investigational Site Number 8407035
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8407051
🇺🇸Anaheim, California, United States
Investigational Site Number 8407084
🇺🇸Tarzana, California, United States
Investigational Site Number 8407098
🇺🇸Northridge, California, United States
Investigational Site Number 8407038
🇺🇸Palmetto Bay, Florida, United States
Investigational Site Number 8407089
🇺🇸Downey, California, United States
Investigational Site Number 8407033
🇺🇸Long Beach, California, United States
Investigational Site Number 8407123
🇺🇸West Seneca, New York, United States
Investigational Site Number 8407096
🇺🇸Rancho Cucamonga, California, United States
Investigational Site Number 8407086
🇺🇸New York, New York, United States
Investigational Site Number 8407044
🇺🇸Greenbrae, California, United States
Investigational Site Number 8407106
🇺🇸Pomona, California, United States
Investigational Site Number 8407057
🇺🇸Norman, Oklahoma, United States
Investigational Site Number 8407116
🇺🇸New York, New York, United States
Investigational Site Number 8407121
🇺🇸Ocoee, Florida, United States
Investigational Site Number 8407115
🇺🇸Winter Haven, Florida, United States
Investigational Site Number 8407050
🇺🇸Albuquerque, New Mexico, United States
Investigational Site Number 8407085
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 8407110
🇺🇸Olive Branch, Mississippi, United States
Investigational Site Number 8407114
🇺🇸Lenoir, North Carolina, United States
Investigational Site Number 8407081
🇺🇸Lyndhurst, Ohio, United States
Investigational Site Number 8407124
🇺🇸Manassas, Virginia, United States
Investigational Site Number 8407028
🇺🇸Renton, Washington, United States
Investigational Site Number 8407090
🇺🇸Katy, Texas, United States
Investigational Site Number 1007003
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 3487007
🇭🇺Nyiregyhaza, Hungary
Investigational Site Number 7037001
🇸🇰Sabinov, Slovakia
Investigational Site Number 8407108
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 8407088
🇺🇸Houston, Texas, United States
Investigational Site Number 8407083
🇺🇸Wichita, Kansas, United States
Investigational Site Number 8407095
🇺🇸Topeka, Kansas, United States
Investigational Site Number 1007002
🇧🇬Gabrovo, Bulgaria
Investigational Site Number 1007008
🇧🇬Plovdiv, Bulgaria
Investigational Site Number 1007001
🇧🇬Ruse, Bulgaria
Investigational Site Number 1007004
🇧🇬Smolyan, Bulgaria
Investigational Site Number 1007009
🇧🇬Sofia, Bulgaria
Investigational Site Number 1007005
🇧🇬Stara Zagora, Bulgaria
Investigational Site Number 1007006
🇧🇬Stara Zagora, Bulgaria
Investigational Site Number 3487005
🇭🇺Balatonfured, Hungary
Investigational Site Number 1007007
🇧🇬Varna, Bulgaria
Investigational Site Number 3487001
🇭🇺Budapest, Hungary
Investigational Site Number 7037002
🇸🇰Levice, Slovakia
Investigational Site Number 3487006
🇭🇺Debrecen, Hungary
Investigational Site Number 3487008
🇭🇺Debrecen, Hungary
Investigational Site Number 3487002
🇭🇺Kecskemet, Hungary
Investigational Site Number 3487004
🇭🇺Nyíregyháza, Hungary
Investigational Site Number 7037004
🇸🇰Bardejov, Slovakia
Investigational Site Number 7037007
🇸🇰Bratislava, Slovakia
Investigational Site Number 3487010
🇭🇺Budapest, Hungary
Investigational Site Number 7037005
🇸🇰Kosice, Slovakia
Investigational Site Number 7037010
🇸🇰Nitra, Slovakia
Investigational Site Number 7037009
🇸🇰Roznava, Slovakia
Investigational Site Number 7037003
🇸🇰Trnava, Slovakia
Investigational Site Number 7037006
🇸🇰Vrutky, Slovakia
Investigational Site Number 8407040
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8407005
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8407072
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 8407113
🇺🇸Tampa, Florida, United States
Investigational Site Number 8407039
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 8407091
🇺🇸Tampa, Florida, United States
Investigational Site Number 8407048
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8407011
🇺🇸Gold River, California, United States
Investigational Site Number 8407037
🇺🇸Lemon Grove, California, United States
Investigational Site Number 8407100
🇺🇸Lomita, California, United States
Investigational Site Number 8407094
🇺🇸Norwalk, California, United States
Investigational Site Number 8407004
🇺🇸Walnut Creek, California, United States
Investigational Site Number 8407045
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 8407062
🇺🇸Lake Worth, Florida, United States
Investigational Site Number 8407107
🇺🇸Spring Hill, Florida, United States
Investigational Site Number 8407093
🇺🇸Pembroke Pines, Florida, United States
Investigational Site Number 8407046
🇺🇸Gurnee, Illinois, United States
Investigational Site Number 8407119
🇺🇸Springfield, Illinois, United States
Investigational Site Number 8407087
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 8407060
🇺🇸Lake Charles, Louisiana, United States
Investigational Site Number 8407079
🇺🇸Zachary, Louisiana, United States
Investigational Site Number 8407001
🇺🇸Rockville, Maryland, United States
Investigational Site Number 8407049
🇺🇸Norfolk, Nebraska, United States
Investigational Site Number 8407122
🇺🇸New York, New York, United States
Investigational Site Number 8407099
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 8407073
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 8407022
🇺🇸Mount Pleasant, South Carolina, United States
Investigational Site Number 8407025
🇺🇸Hatboro, Pennsylvania, United States
Investigational Site Number 8407053
🇺🇸Lansdale, Pennsylvania, United States
Investigational Site Number 8407071
🇺🇸Greer, South Carolina, United States
Investigational Site Number 8407031
🇺🇸Mount Pleasant, South Carolina, United States
Investigational Site Number 8407014
🇺🇸Jefferson City, Tennessee, United States
Investigational Site Number 8407056
🇺🇸Memphis, Tennessee, United States
Investigational Site Number 8407029
🇺🇸Beaumont, Texas, United States
Investigational Site Number 8407070
🇺🇸Carrollton, Texas, United States
Investigational Site Number 8407102
🇺🇸Corpus Christi, Texas, United States
Investigational Site Number 8407023
🇺🇸Dallas, Texas, United States
Investigational Site Number 8407013
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 8407080
🇺🇸Houston, Texas, United States
Investigational Site Number 8407042
🇺🇸Lampasas, Texas, United States
Investigational Site Number 8407067
🇺🇸Lufkin, Texas, United States
Investigational Site Number 8407059
🇺🇸McAllen, Texas, United States
Investigational Site Number 8407118
🇺🇸Lufkin, Texas, United States
Investigational Site Number 8407064
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8407076
🇺🇸Splendora, Texas, United States
Investigational Site Number 8407063
🇺🇸Clinton, Utah, United States
Investigational Site Number 8407055
🇺🇸Holladay, Utah, United States
Investigational Site Number 8407097
🇺🇸Ogden, Utah, United States
Investigational Site Number 7037008
🇸🇰Bratislava, Slovakia
Investigational Site Number 8407054
🇺🇸Bridgeton, Missouri, United States
Investigational Site Number 8407034
🇺🇸Upland, California, United States
Investigational Site Number 8407032
🇺🇸Van Nuys, California, United States
Investigational Site Number 8407027
🇺🇸Clearwater, Florida, United States
Investigational Site Number 8407103
🇺🇸Cooper City, Florida, United States
Investigational Site Number 8407092
🇺🇸West Palm Beach, Florida, United States
Investigational Site Number 8407021
🇺🇸Coral Gables, Florida, United States
Investigational Site Number 8407017
🇺🇸Chicago, Illinois, United States
Investigational Site Number 8407018
🇺🇸Elgin, Illinois, United States
Investigational Site Number 8407075
🇺🇸Waterloo, Iowa, United States
Investigational Site Number 8407043
🇺🇸Lexington, Kentucky, United States
Investigational Site Number 8407120
🇺🇸West Des Moines, Iowa, United States
Investigational Site Number 8407020
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 8407015
🇺🇸Morehead City, North Carolina, United States
Investigational Site Number 8407030
🇺🇸Salisbury, North Carolina, United States
Investigational Site Number 8407104
🇺🇸Beaver, Pennsylvania, United States
Investigational Site Number 8407041
🇺🇸Wilmington, North Carolina, United States
Investigational Site Number 8407069
🇺🇸Troy, Michigan, United States
Investigational Site Number 8407061
🇺🇸Papillion, Nebraska, United States
Investigational Site Number 8407002
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 8407068
🇺🇸Eugene, Oregon, United States
Investigational Site Number 8407058
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8407009
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8407016
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 8407105
🇺🇸Richmond, Virginia, United States
Investigational Site Number 8407036
🇺🇸Sacramento, California, United States
Investigational Site Number 8407026
🇺🇸Austin, Texas, United States
Investigational Site Number 8407024
🇺🇸Orlando, Florida, United States
Investigational Site Number 8407101
🇺🇸Winston-Salem, North Carolina, United States
Investigational Site Number 8407117
🇺🇸Wildomar, California, United States
Investigational Site Number 8407012
🇺🇸Mesquite, Texas, United States
Investigational Site Number 8407007
🇺🇸Plano, Texas, United States
Investigational Site Number 8407010
🇺🇸Schertz, Texas, United States