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Type 1 Diabetes MellitusPhase 2NCT02383940

Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

A Phase 2 study testing Sotagliflozin in people with Type 1 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen. Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Sotagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
15 sitesUnited States
Study dates
Apr 2015to Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participant had given written informed consent.
  • Young adult participants >=18 to <=30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent.
  • Participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
  • At Screening, must had A1C >= 9.0%.
  • Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary.
  • Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test.

Who cannot join

  • Any prior use of LX4211/sotagliflozin.
  • Use of antidiabetic agent other than insulin or insulin analogue at the time of screening.
  • Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period.
  • Chronic systemic corticosteroid use.
  • Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator.
  • History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit.
  • History of severe hypoglycemic event within 1 month prior to the Screening Visit.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Lexicon Investigational Site

    Atlanta, Georgia, 30318

  • Lexicon Investigational Site

    Auburn, Maine, 04210

  • Lexicon Investigational Site

    Aurora, Colorado, 80045

  • Lexicon Investigational Site

    Austin, Texas, 78749

  • Lexicon Investigational Site

    Boston, Massachusetts, 02215

  • Lexicon Investigational Site

    Buffalo, New York, 14222

  • Lexicon Investigational Site

    Indianapolis, Indiana, 46202

  • Lexicon Investigational Site

    New Haven, Connecticut, 06519

  • Lexicon Investigational Site

    New Orleans, Louisiana, 70121

  • Lexicon Investigational Site

    Roswell, Georgia, 30076

  • Lexicon Investigational Site

    Salt Lake City, Utah, 84107

  • Lexicon Investigational Site

    Tampa, Florida, 33612

  • Lexicon Investigational Site

    Tustin, California, 92780

  • Lexicon Investigational Site

    West Palm Beach, Florida, 33401

  • Lexicon Investigational Site

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX4211 in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.

Being tested
Sotagliflozin, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotagliflozinDrug

    Also called LX4211

    Sotagliflozin 400 mg, once daily before the first meal of the day

  • PlaceboDrug

    Placebo, once daily before the first meal of the day

Study groups in NCT02383940
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTwo placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.
Receives: Drug: Placebo
Sotagliflozin 400 mgExperimentalSotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
Receives: Drug: Sotagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Hemoglobin A1C (A1C) at Week 12

    Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (<=10%, >10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.

    Measured: Baseline, Week 12

Secondary outcomes (4)

  1. Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12

    The daily bolus and basal insulin doses were calculated as an average of the doses over 3 to 5 days before each visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.

    Measured: Baseline, Week 12

  2. Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12

    A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. At Week 12, study drug was to be given within 15 minutes before liquid "Boost®," "Ensure®," or similar nutrition drink product; at baseline, study drug was to be given after the 2-hour post-Mixed Meal PPG sample. Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from analysis of covariance (ANCOVA) model.

    Measured: Baseline, Week 12

  3. Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12

    Glycemic instability (mg/dL*minutes/1000) by hyperglycemia/hypoglycemia was measured by CGM AUC outside target range (as a daily average over the week prior to the visit [Baseline and Week 12]) over 24 hours, where outside target range was defined as CGM glucose AUC >150 mg/dL (hyperglycemia) and CGM glucose AUC <70 mg/dL (hypoglycemia). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.

    Measured: Baseline, Week 12

  4. Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12

    Hypoglycemic event by SMBG was defined as an event in which the fingerstick measurement was <=70 mg/dL. The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week prior to visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02383940
Sponsor's protocol ID
LX4211.1-204-T1DM
Other IDs
LX4211.204
Status last verified
Feb 2020
First submitted
19 Feb 2015
Last updated
12 Feb 2020
Data monitoring committee
Yes

Publications

  • Bode BW, Cengiz E, Wadwa RP, Banks P, Danne T, Kushner JA, McGuire DK, Peters AL, Strumph P, Sawhney S. Effects of Sotagliflozin Combined with Intensive Insulin Therapy in Young Adults with Poorly Controlled Type 1 Diabetes: The JDRF Sotagliflozin Study. Diabetes Technol Ther. 2021 Jan;23(1):59-69. doi: 10.1089/dia.2020.0079.

    PubMed 32640846

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotagliflozin in people with Type 1 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1C (A1C) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02383940, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.

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