Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
Public ClinicalTrials.gov record NCT03332771. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Glimepiride or Placebo Added to Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin Monotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03332771
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 954 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2017 (Actual)
- Primary completion
- Aug 6, 2019 (Actual)
- Completion
- Sep 6, 2019 (Actual)
- Last update posted
- May 11, 2021
2017 – 2019
United States locations
- U.S. sites
- 115
- U.S. states
- 29
- U.S. cities
- 104
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8407040 | Birmingham | Alabama | 35205 | — |
| Investigational Site Number 8407048 | Birmingham | Alabama | 35233-2110 | — |
| Investigational Site Number 8407035 | Little Rock | Arkansas | 72211 | — |
| Investigational Site Number 8407051 | Anaheim | California | 92801-2417 | — |
| Investigational Site Number 8407065 | Canoga Park | California | 91301 | — |
| Investigational Site Number 8407078 | Carmichael | California | 95608 | — |
| Investigational Site Number 8407089 | Downey | California | 90242 | — |
| Investigational Site Number 8407011 | Gold River | California | 95670 | — |
| Investigational Site Number 8407044 | Greenbrae | California | 94904 | — |
| Investigational Site Number 8407006 | Huntington Park | California | 90255-2911 | — |
| Investigational Site Number 8407037 | Lemon Grove | California | 91945 | — |
| Investigational Site Number 8407100 | Lomita | California | 90717 | — |
| Investigational Site Number 8407033 | Long Beach | California | 90806 | — |
| Investigational Site Number 8407019 | Los Angeles | California | 90057-3507 | — |
| Investigational Site Number 8407098 | Northridge | California | 91325-5409 | — |
| Investigational Site Number 8407094 | Norwalk | California | 90650 | — |
| Investigational Site Number 8407106 | Pomona | California | 91766 | — |
| Investigational Site Number 8407096 | Rancho Cucamonga | California | 91730 | — |
| Investigational Site Number 8407036 | Sacramento | California | 95821 | — |
| Investigational Site Number 8407084 | Tarzana | California | 91356-3551 | — |
| Investigational Site Number 8407034 | Upland | California | 91786-4070 | — |
| Investigational Site Number 8407032 | Van Nuys | California | 91405 | — |
| Investigational Site Number 8407004 | Walnut Creek | California | 94598 | — |
| Investigational Site Number 8407117 | Wildomar | California | 92595 | — |
| Investigational Site Number 8407045 | Colorado Springs | Colorado | 80920-8075 | — |
| Investigational Site Number 8407074 | Bradenton | Florida | 34201 | — |
| Investigational Site Number 8407027 | Clearwater | Florida | 33761 | — |
| Investigational Site Number 8407103 | Cooper City | Florida | 33024 | — |
| Investigational Site Number 8407021 | Coral Gables | Florida | 33134 | — |
| Investigational Site Number 8407062 | Lake Worth | Florida | 33467 | — |
| Investigational Site Number 8407121 | Ocoee | Florida | 34761 | — |
| Investigational Site Number 8407024 | Orlando | Florida | 32825-4454 | — |
| Investigational Site Number 8407038 | Palmetto Bay | Florida | 33157-5503 | — |
| Investigational Site Number 8407093 | Pembroke Pines | Florida | 33026-3924 | — |
| Investigational Site Number 8407107 | Spring Hill | Florida | 34609 | — |
| Investigational Site Number 8407091 | Tampa | Florida | 33619 | — |
| Investigational Site Number 8407113 | Tampa | Florida | 33634 | — |
| Investigational Site Number 8407092 | West Palm Beach | Florida | 33401 | — |
| Investigational Site Number 8407115 | Winter Haven | Florida | 33880 | — |
| Investigational Site Number 8407017 | Chicago | Illinois | 60607 | — |
| Investigational Site Number 8407018 | Elgin | Illinois | 60124 | — |
| Investigational Site Number 8407046 | Gurnee | Illinois | 60031 | — |
| Investigational Site Number 8407119 | Springfield | Illinois | 62711 | — |
| Investigational Site Number 8407075 | Waterloo | Iowa | 50702 | — |
| Investigational Site Number 8407120 | West Des Moines | Iowa | 50265 | — |
| Investigational Site Number 8407095 | Topeka | Kansas | 66606-2806 | — |
| Investigational Site Number 8407083 | Wichita | Kansas | 67205-1138 | — |
| Investigational Site Number 8407043 | Lexington | Kentucky | 40503-2517 | — |
| Investigational Site Number 8407087 | Lexington | Kentucky | 40503 | — |
| Investigational Site Number 8407060 | Lake Charles | Louisiana | 70601 | — |
| Investigational Site Number 8407058 | New Orleans | Louisiana | 70119 | — |
| Investigational Site Number 8407009 | New Orleans | Louisiana | 70124 | — |
| Investigational Site Number 8407079 | Zachary | Louisiana | 70791-4010 | — |
| Investigational Site Number 8407085 | Baltimore | Maryland | 21237 | — |
| Investigational Site Number 8407001 | Rockville | Maryland | 20852 | — |
| Investigational Site Number 8407069 | Troy | Michigan | 48098-6334 | — |
| Investigational Site Number 8407110 | Olive Branch | Mississippi | 38654 | — |
| Investigational Site Number 8407054 | Bridgeton | Missouri | 63044 | — |
| Investigational Site Number 8407049 | Norfolk | Nebraska | 68701 | — |
| Investigational Site Number 8407039 | Omaha | Nebraska | 68114 | — |
| Investigational Site Number 8407061 | Papillion | Nebraska | 68046-3136 | — |
| Investigational Site Number 8407108 | Las Vegas | Nevada | 89106-4132 | — |
| Investigational Site Number 8407050 | Albuquerque | New Mexico | 87106 | — |
| Investigational Site Number 8407116 | New York | New York | 10016-6402 | — |
| Investigational Site Number 8407086 | New York | New York | 10029 | — |
| Investigational Site Number 8407122 | New York | New York | 10036 | — |
| Investigational Site Number 8407123 | West Seneca | New York | 14224 | — |
| Investigational Site Number 8407020 | Greensboro | North Carolina | 27408 | — |
| Investigational Site Number 8407114 | Lenoir | North Carolina | 28645-8981 | — |
| Investigational Site Number 8407015 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 8407030 | Salisbury | North Carolina | 28144-2742 | — |
| Investigational Site Number 8407041 | Wilmington | North Carolina | 28401-6638 | — |
| Investigational Site Number 8407101 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 8407099 | Cincinnati | Ohio | 45245 | — |
| Investigational Site Number 8407081 | Lyndhurst | Ohio | 44124-2467 | — |
| Investigational Site Number 8407057 | Norman | Oklahoma | 73069 | — |
| Investigational Site Number 8407073 | Oklahoma City | Oklahoma | 73104-3252 | — |
| Investigational Site Number 8407068 | Eugene | Oregon | 97404 | — |
| Investigational Site Number 8407104 | Beaver | Pennsylvania | 15009-1957 | — |
| Investigational Site Number 8407025 | Hatboro | Pennsylvania | 19040-2045 | — |
| Investigational Site Number 8407053 | Lansdale | Pennsylvania | 19446-1002 | — |
| Investigational Site Number 8407016 | Charleston | South Carolina | 29407 | — |
| Investigational Site Number 8407071 | Greer | South Carolina | 29651-1817 | — |
| Investigational Site Number 8407022 | Mt. Pleasant | South Carolina | 29464 | — |
| Investigational Site Number 8407031 | Mt. Pleasant | South Carolina | 29464 | — |
| Investigational Site Number 8407014 | Jefferson City | Tennessee | 37760 | — |
| Investigational Site Number 8407002 | Knoxville | Tennessee | 37938 | — |
| Investigational Site Number 8407056 | Memphis | Tennessee | 38163 | — |
| Investigational Site Number 8407026 | Austin | Texas | 78735-8982 | — |
| Investigational Site Number 8407029 | Beaumont | Texas | 77702 | — |
| Investigational Site Number 8407070 | Carrollton | Texas | 75010 | — |
| Investigational Site Number 8407102 | Corpus Christi | Texas | 78414-4173 | — |
| Investigational Site Number 8407023 | Dallas | Texas | 75230 | — |
| Investigational Site Number 8407111 | Dallas | Texas | 75231 | — |
| Investigational Site Number 8407013 | Fort Worth | Texas | 76164 | — |
| Investigational Site Number 8407080 | Houston | Texas | 77040 | — |
| Investigational Site Number 8407088 | Houston | Texas | 77095-2856 | — |
| Investigational Site Number 8407090 | Katy | Texas | 77450 | — |
| Investigational Site Number 8407042 | Lampasas | Texas | 76550-1820 | — |
| Investigational Site Number 8407067 | Lufkin | Texas | 75904 | — |
| Investigational Site Number 8407118 | Lufkin | Texas | 75904 | — |
| Investigational Site Number 8407059 | McAllen | Texas | 78504 | — |
| Investigational Site Number 8407012 | Mesquite | Texas | 75149 | — |
| Investigational Site Number 8407007 | Plano | Texas | 75075 | — |
| Investigational Site Number 8407005 | San Antonio | Texas | 78218 | — |
| Investigational Site Number 8407064 | San Antonio | Texas | 78229-3818 | — |
| Investigational Site Number 8407010 | Schertz | Texas | 78154 | — |
| Investigational Site Number 8407076 | Splendora | Texas | 77372 | — |
| Investigational Site Number 8407063 | Clinton | Utah | 84015 | — |
| Investigational Site Number 8407055 | Holladay | Utah | 84117-7054 | — |
| Investigational Site Number 8407097 | Ogden | Utah | 84405 | — |
| Investigational Site Number 8407072 | Salt Lake City | Utah | 84102-1553 | — |
| Investigational Site Number 8407124 | Manassas | Virginia | 20110-4421 | — |
| Investigational Site Number 8407105 | Richmond | Virginia | 23249-0001 | — |
| Investigational Site Number 8407028 | Renton | Washington | 98055 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03332771, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 11, 2021 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03332771 live on ClinicalTrials.gov.