Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
- Conditions
- Type 2 Diabetes MellitusChronic Kidney Disease Stage 3
- Interventions
- Drug: Placebo
- Registration Number
- NCT03242252
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
Primary Objective:
To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment.
Secondary Objectives:
* To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight.
* To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.
- Detailed Description
The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 787
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sotagliflozin 200 mg Placebo Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks. Sotagliflozin 400 mg Sotagliflozin Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks. Placebo Placebo Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks. Sotagliflozin 200 mg Sotagliflozin Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c at Week 26 Baseline to Week 26 An Analysis of covariance (ANCOVA) model was used for analysis.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Up to 60 weeks Percentage of Participants With HbA1c <7.0% at Week 26 Week 26 Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12 Baseline to Week 12 An ANCOVA model was used for analysis.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 Baseline to Week 26 An ANCOVA model was used for analysis.
Change From Baseline in SBP at Week 12 for All Participants Baseline to Week 12 An ANCOVA model was used for analysis.
Change From Baseline in Body Weight at Week 26 Baseline to Week 26 An ANCOVA model was used for analysis.
Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g) Baseline to Week 26 An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
Percentage of Participants With HbA1c <6.5% at Week 26 Week 26
Trial Locations
- Locations (170)
Investigational Site Number 8404016
🇺🇸Savannah, Georgia, United States
Investigational Site Number 8404057
🇺🇸Round Rock, Texas, United States
Investigational Site Number 8404055
🇺🇸Houston, Texas, United States
Investigational Site Number 8404022
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 8404059
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8404010
🇺🇸San Antonio, Texas, United States
Investigational Site Number 3484008
🇭🇺Baja, Hungary
Investigational Site Number 3484011
🇭🇺Debrecen, Hungary
Investigational Site Number 8044006
🇺🇦Kyiv, Ukraine
Investigational Site Number 8044005
🇺🇦Lviv, Ukraine
Investigational Site Number 3484013
🇭🇺Nyregyhza, Hungary
Investigational Site Number 3764010
🇮🇱Be'Er-Sheva, Israel
Investigational Site Number 3764007
🇮🇱Haifa, Israel
Investigational Site Number 6164004
🇵🇱Krakow, Poland
Investigational Site Number 8044009
🇺🇦Kyiv, Ukraine
Investigational Site Number 0324008
🇦🇷Cordoba, Argentina
Investigational Site Number 3764013
🇮🇱Zerifin, Israel
Investigational Site Number 6424001
🇷🇴Bacau, Romania
Investigational Site Number 6424011
🇷🇴Oradea, Romania
Investigational Site Number 8044007
🇺🇦Kharkiv, Ukraine
Investigational Site Number 8044003
🇺🇦Kiev, Ukraine
Investigational Site Number 0324009
🇦🇷La Plata, Argentina
Investigational Site Number 3484012
🇭🇺Baja, Hungary
Investigational Site Number 8404007
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8404048
🇺🇸Hackensack, New Jersey, United States
Investigational Site Number 1704006
🇨🇴Ibague, Colombia
Investigational Site Number 3484005
🇭🇺Debrecen, Hungary
Investigational Site Number 6424002
🇷🇴Bacau, Romania
Investigational Site Number 6424004
🇷🇴Bucuresti, Romania
Investigational Site Number 6424009
🇷🇴Bucuresti, Romania
Investigational Site Number 6424003
🇷🇴Targu-Mures, Romania
Investigational Site Number 3484007
🇭🇺Budapest, Hungary
Investigational Site Number 3484004
🇭🇺Pécs, Hungary
Investigational Site Number 3764008
🇮🇱Zefat, Israel
Investigational Site Number 6164012
🇵🇱Skierniewice, Poland
Investigational Site Number 6434002
🇷🇺Krasnodar, Russian Federation
Investigational Site Number 8044004
🇺🇦Dnipropetrovsk, Ukraine
Investigational Site Number 8404036
🇺🇸Lake Charles, Louisiana, United States
Investigational Site Number 8404011
🇺🇸Los Angeles, California, United States
Investigational Site Number 8404041
🇺🇸Seattle, Washington, United States
Investigational Site Number 8404043
🇺🇸Ormond Beach, Florida, United States
Investigational Site Number 8404014
🇺🇸Norfolk, Nebraska, United States
Investigational Site Number 8404038
🇺🇸San Dimas, California, United States
Investigational Site Number 8404004
🇺🇸Phoenix, Arizona, United States
Investigational Site Number 8404044
🇺🇸Gold River, California, United States
Investigational Site Number 8404019
🇺🇸Clearwater, Florida, United States
Investigational Site Number 8404045
🇺🇸Guntersville, Alabama, United States
Investigational Site Number 8404026
🇺🇸Dayton, Ohio, United States
Investigational Site Number 8404013
🇺🇸Palmetto Bay, Florida, United States
Investigational Site Number 8404032
🇺🇸Papillion, Nebraska, United States
Investigational Site Number 8404074
🇺🇸New York, New York, United States
Investigational Site Number 8404051
🇺🇸Wilmington, North Carolina, United States
Investigational Site Number 8404056
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 8404052
🇺🇸Lansdale, Pennsylvania, United States
Investigational Site Number 8404008
🇺🇸Layton, Utah, United States
Investigational Site Number 8404031
🇺🇸Anderson, South Carolina, United States
Investigational Site Number 8404033
🇺🇸Lampasas, Texas, United States
Investigational Site Number 0324002
🇦🇷Caba, Argentina
Investigational Site Number 0324005
🇦🇷Ciudad Autónoma Buenos Aires, Argentina
Investigational Site Number 8404035
🇺🇸Dallas, Texas, United States
Investigational Site Number 8404005
🇺🇸Beaumont, Texas, United States
Investigational Site Number 1244007
🇨🇦Brampton, Canada
Investigational Site Number 8404039
🇺🇸Houston, Texas, United States
Investigational Site Number 8404012
🇺🇸Hurst, Texas, United States
Investigational Site Number 8404053
🇺🇸McAllen, Texas, United States
Investigational Site Number 0324001
🇦🇷Buenos Aires, Argentina
Investigational Site Number 0324007
🇦🇷Mar Del Plata, Argentina
Investigational Site Number 0764001
🇧🇷Belém, Brazil
Investigational Site Number 0324006
🇦🇷Córdoba, Argentina
Investigational Site Number 1704008
🇨🇴Barranquilla, Colombia
Investigational Site Number 1244004
🇨🇦Burlington, Canada
Investigational Site Number 1244005
🇨🇦Etobicoke, Canada
Investigational Site Number 0764004
🇧🇷São Paulo, Brazil
Investigational Site Number 1704007
🇨🇴Barranquilla, Colombia
Investigational Site Number 3484002
🇭🇺Balatonfured, Hungary
Investigational Site Number 3484001
🇭🇺Gyula, Hungary
Investigational Site Number 2764002
🇩🇪Hamburg, Germany
Investigational Site Number 1244002
🇨🇦Toronto, Canada
Investigational Site Number 1244006
🇨🇦Laval, Canada
Investigational Site Number 3764005
🇮🇱Rehovot, Israel
Investigational Site Number 1244001
🇨🇦Vancouver, Canada
Investigational Site Number 2764001
🇩🇪Frankfurt Am Main, Germany
Investigational Site Number 1244010
🇨🇦Ottawa, Canada
Investigational Site Number 2764003
🇩🇪Münster, Germany
Investigational Site Number 1704004
🇨🇴Bogota, Colombia
Investigational Site Number 1704002
🇨🇴Medellin / Antioquia, Colombia
Investigational Site Number 1244008
🇨🇦Toronto, Canada
Investigational Site Number 1704009
🇨🇴Bogota, Colombia
Investigational Site Number 1704001
🇨🇴Manizales, Colombia
Investigational Site Number 3764001
🇮🇱Ashkelon, Israel
Investigational Site Number 3764003
🇮🇱Nahariya, Israel
Investigational Site Number 3764004
🇮🇱Petach Tikva, Israel
Investigational Site Number 3764006
🇮🇱Ramat Gan, Israel
Investigational Site Number 3484010
🇭🇺Nyiregyhaza, Hungary
Investigational Site Number 3764011
🇮🇱Kfar-Saba, Israel
Investigational Site Number 3764009
🇮🇱Kfar-Saba, Israel
Investigational Site Number 3764002
🇮🇱Tel Aviv, Israel
Investigational Site Number 4844004
🇲🇽Xalapa, Mexico
Investigational Site Number 6164010
🇵🇱Krakow, Poland
Investigational Site Number 4844001
🇲🇽Guadalajara, Mexico
Investigational Site Number 4844009
🇲🇽Chihuahua Chihuahua, Mexico
Investigational Site Number 4844008
🇲🇽Durango, Durango, Mexico
Investigational Site Number 4844005
🇲🇽Monterrey, Mexico
Investigational Site Number 6164006
🇵🇱Katowice, Poland
Investigational Site Number 6164002
🇵🇱Białystok, Poland
Investigational Site Number 6164009
🇵🇱Krakow, Poland
Investigational Site Number 6424010
🇷🇴Bucuresti, Romania
Investigational Site Number 6424006
🇷🇴Hunedoara, Romania
Investigational Site Number 6434003
🇷🇺Chelyabinsk, Russian Federation
Investigational Site Number 6434004
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 7104008
🇿🇦Cape Town, South Africa
Investigational Site Number 7104005
🇿🇦Johannesburg, South Africa
Investigational Site Number 7244007
🇪🇸Granada, Spain
Investigational Site Number 7244002
🇪🇸Valencia, Spain
Investigational Site Number 7244009
🇪🇸Zaragoza, Spain
Investigational Site Number 3804007
🇮🇹Catania, Italy
Investigational Site Number 3804005
🇮🇹Milano, Italy
Investigational Site Number 3804004
🇮🇹Milano, Italy
Investigational Site Number 3804008
🇮🇹Naples, Italy
Investigational Site Number 3804002
🇮🇹Napoli, Italy
Investigational Site Number 3804003
🇮🇹Roma, Italy
Investigational Site Number 3804006
🇮🇹Siena, Italy
Investigational Site Number 0764007
🇧🇷Belo Horizonte, Brazil
Investigational Site Number 0764006
🇧🇷Sao Paulo, Brazil
Investigational Site Number 0764008
🇧🇷Curitiba, Brazil
Investigational Site Number 0764005
🇧🇷Rio De Janeiro, Brazil
Investigational Site Number 1244003
🇨🇦Thornhill, Canada
Investigational Site Number 1244009
🇨🇦Montreal, Canada
Investigational Site Number 8404018
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 7244003
🇪🇸Madrid, Spain
Investigational Site Number 7244006
🇪🇸Palma De Mallorca, Spain
Investigational Site Number 7244001
🇪🇸Sevilla, Spain
Investigational Site Number 8404001
🇺🇸DeLand, Florida, United States
Investigational Site Number 8404006
🇺🇸Ocoee, Florida, United States
Investigational Site Number 8404047
🇺🇸Kenosha, Wisconsin, United States
Investigational Site Number 8404042
🇺🇸Renton, Washington, United States
Investigational Site Number 8404023
🇺🇸Chula Vista, California, United States
Investigational Site Number 8404003
🇺🇸Norco, California, United States
Investigational Site Number 8404025
🇺🇸Northridge, California, United States
Investigational Site Number 8404040
🇺🇸Wauconda, Illinois, United States
Investigational Site Number 0764002
🇧🇷Curitiba, Brazil
Investigational Site Number 1704005
🇨🇴Zipaquira, Colombia
Investigational Site Number 4844003
🇲🇽Guadalajara, Mexico
Investigational Site Number 4844006
🇲🇽Merida, Yucatan, Mexico
Investigational Site Number 6164008
🇵🇱Krakow, Poland
Investigational Site Number 6164011
🇵🇱Lodz, Poland
Investigational Site Number 6164005
🇵🇱Oswiecim, Poland
Investigational Site Number 6164003
🇵🇱Rzeszow, Poland
Investigational Site Number 6164007
🇵🇱Warszawa, Poland
Investigational Site Number 6434005
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 7104001
🇿🇦Johannesburg, South Africa
Investigational Site Number 6434006
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 6434001
🇷🇺St. Petersburg, Russian Federation
Investigational Site Number 7104002
🇿🇦Cape Town, South Africa
Investigational Site Number 7104010
🇿🇦Johannesburg, South Africa
Investigational Site Number 7244011
🇪🇸Barcelona, Spain
Investigational Site Number 7104006
🇿🇦Pretoria, South Africa
Investigational Site Number 8044010
🇺🇦Kharkiv, Ukraine
Investigational Site Number 8044008
🇺🇦Kiev, Ukraine
Investigational Site Number 8044002
🇺🇦Zaporizhia, Ukraine
Investigational Site Number 8044001
🇺🇦Kyiv, Ukraine
Investigational Site Number 8404064
🇺🇸Orlando, Florida, United States
Investigational Site Number 8404020
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8404009
🇺🇸Bronx, New York, United States
Investigational Site Number 8404029
🇺🇸Winston-Salem, North Carolina, United States
Investigational Site Number 8404050
🇺🇸Austin, Texas, United States
Investigational Site Number 8404060
🇺🇸Austin, Texas, United States
Investigational Site Number 8404028
🇺🇸Winston-Salem, North Carolina, United States
Investigational Site Number 8404015
🇺🇸Austin, Texas, United States
Investigational Site Number 8404021
🇺🇸Mount Pleasant, South Carolina, United States