ClinicalTrials.gg
Sign In
CompletedNCT00924053Updated Jun 17, 2019Results posted

Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes

A Phase 1 interventional study of EGT0001474 and Placebo in Diabetes Mellitus Type 2, sponsored by Theracos. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by Theracos · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how much of the drug gets into the blood and how long it takes the body to get rid of it) of single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.

Read the detailed description

EGT0001474 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001474 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. This would help prevent an abnormal decrease in blood sugar (hypoglycemia) both during fasting and after meals without increasing insulin secretion (which may result in weight gain or an abnormal increase in blood sugar known as Type 2 diabetes).

02

Conditions studied

  • Diabetes Mellitus Type 2

Keywords

  • Diabetes Mellitus Type 2
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 24 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Theracos is the lead sponsor of 21 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or females between the ages of 18 to 70 diagnosed with Type 2 diabetes.
  • Body mass Index (BMI) between 18 kg/m2 and 37 kg/m2.
  • HbA1c levels between 6.5 and 9.0 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or 6.2-9.0% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1% and fasting plasma glucose between 110 and 240 mg/dL (inclusive) while on diabetic medications.
  • If taking drugs for diabetes, must be medically able and willing to discontinue diabetes medications for the duration of the study.
  • Female subjects must be surgically sterilized or postmenopausal.
  • Non-smoker for at least 3 months.
  • Negative alcohol screen.

Exclusion criteria

Exclusion Criteria:

  • Type 1 diabetes.
  • Use of insulin therapy or oral antidiabetic medication other than metformin, sitagliptin or a sulfonylurea.
  • Sitting blood pressure above 150/95 mmHg on 2 evaluations at least 10 minutes apart at screening.
  • Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
  • Previous treatment with EGT0001474.
  • Vaccination within 30 days prior to the first dose of study medication.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    EGT0001474

    Drug: EGT0001474

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugEGT0001474

    Cohort 1: single dose of 25 mg EGT0001474 given as an oral capsule; Cohort 2: single dose of 75 mg EGT0001474 given as 3 oral capsules; Cohort 3: single dose of 150 mg EGT0001474 given as 6 oral capsules.

    Also known as: Human SGLT2 inhibitor

  • DrugPlacebo

    Placebo capsules to match EGT0001474

    Also known as: Human SGLT2 inhibitor

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability of EGT0001474

    Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.

    Time frame: 25 days

  2. AUC 0-t

    Area under the plasma concentration-time curve from time 0 to time t

    Time frame: 3 days

  3. AUC0-24

    Area under the plasma concentration-time curve from time 0 to hour 24

    Time frame: 3 days

  4. AUC Inf

    Area under the plasma concentration-time curve from time 0 to infinity

    Time frame: 3 days

  5. Cmax

    Maximum plasma concentration

    Time frame: 3 days

  6. Tmax

    Time of maximum plasma concentration

    Time frame: 3 days

  7. λz

    Terminal phase rate constant

    Time frame: 3 days

  8. t1/2

    Apparent terminal half life

    Time frame: 3 days

  9. CL/F

    The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.

    Time frame: 3 days

  10. Vz/F

    Apparent volume of distribution

    Time frame: 3 days

07

Results

Posted Aug 17, 2011

Participant flow

The first subject was enrolled on 12 Jun 2009; the last subject was completed on 28 Jul 2009. Subjects participated at a CRO in San Antonio, TX.

Participant flow — Overall Study
MilestonePlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
Started6666
Completed6666
Not completed0000

Outcome measures

PrimarySafety and Tolerability of EGT0001474

Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.

Time frame:
25 days
Reported as:
Number · Events
Safety and Tolerability of EGT0001474
EventsPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
Mild adverse events5093
Moderate adverse events0001
Serious adverse events0000
PrimaryAUC 0-t

Area under the plasma concentration-time curve from time 0 to time t

Time frame:
3 days
Reported as:
Mean · ng*hr/mL
AUC 0-t
ng*hr/mLPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
AUC 0-tNA ± NA1103.89 ± 470.313370.29 ± 499.366177.8 ± 1691.04
PrimaryAUC0-24

Area under the plasma concentration-time curve from time 0 to hour 24

Time frame:
3 days
Reported as:
Mean · ng*hr/mL
AUC0-24
ng*hr/mLPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
AUC0-24NA ± NA987.3 ± 368.212990.63 ± 461.185584.72 ± 1516.64
PrimaryAUC Inf

Area under the plasma concentration-time curve from time 0 to infinity

Time frame:
3 days
Reported as:
Mean · ng*hr/mL
AUC Inf
ng*hr/mLPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
AUC InfNA ± NA1165.59 ± 479.883532.02 ± 524.746399.55 ± 1736.38
PrimaryCmax

Maximum plasma concentration

Time frame:
3 days
Reported as:
Mean · ng/mL
Cmax
ng/mLPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
CmaxNA ± NA157.23 ± 76.25518.67 ± 176.361014 ± 372.63
PrimaryTmax

Time of maximum plasma concentration

Time frame:
3 days
Reported as:
Median · hour
Tmax
hourPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
TmaxNA (NA to NA)3 (1 to 8)2 (1 to 6)2 (0.5 to 6)
Primaryλz

Terminal phase rate constant

Time frame:
3 days
Reported as:
Mean · 1/hour
λz
1/hourPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
λzNA ± NA0.0741 ± 0.02150.0613 ± 0.01680.0622 ± 0.0195
Primaryt1/2

Apparent terminal half life

Time frame:
3 days
Reported as:
Mean · hour
t1/2
hourPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
t1/2NA ± NA10.1 ± 3.2112.18 ± 3.8812.15 ± 3.94
PrimaryCL/F

The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.

Time frame:
3 days
Reported as:
Mean · mL/hr
CL/F
mL/hrPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
CL/FNA ± NA24479.26 ± 9146.5221616.42 ± 3112.3824996.33 ± 7009.45
PrimaryVz/F

Apparent volume of distribution

Time frame:
3 days
Reported as:
Mean · mL
Vz/F
mLPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
Vz/FNA ± NA348376.12 ± 15666.55382783.75 ± 138953.19435944.78 ± 179821.44

Adverse events

Collected over 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/6 (0%)2/6 (33.3%)
EGT0001474 25 mg—0/6 (0%)0/6 (0%)
EGT0001474 75 mg—0/6 (0%)4/6 (66.7%)
EGT0001474 150mg—0/6 (0%)2/6 (33.3%)
Most frequent other events
Most frequent other events
EventPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mg
HeadacheNervous system disorders0/60/63/62/6
ArthralgiaMusculoskeletal and connective tissue disorders1/60/60/60/6
Blood triglyceride increasedInvestigations0/60/60/61/6
DizzinessNervous system disorders0/60/61/60/6
MalaiseGeneral disorders0/60/61/6—
Muscle spasmsMusculoskeletal and connective tissue disorders1/60/60/60/6
Musculoskeletal stiffnessNervous system disorders—0/61/60/6
NauseaGastrointestinal disorders0/60/61/61/6
Vessel puncture site haematomaInvestigations1/60/60/60/6
Vessel puncture site reactionGeneral disorders1/60/6—0/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mgTotal
<=18 years00000
Between 18 and 65 years666624
>=65 years00000
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mgTotal
Female234312
Male432312
08

Study locations

1 site
  • dgd Research Inc., a Cetero Research Company
    San Antonio, Texas 78229, United States
09

References and documents

Publications

  • Blondel O, Bailbe D, Portha B. Insulin resistance in rats with non-insulin-dependent diabetes induced by neonatal (5 days) streptozotocin: evidence for reversal following phlorizin treatment. Metabolism. 1990 Aug;39(8):787-93. doi: 10.1016/0026-0495(90)90120-2. PubMed 2198430 ↗
  • Cowie CC, Rust KF, Byrd-Holt DD, Eberhardt MS, Flegal KM, Engelgau MM, Saydah SH, Williams DE, Geiss LS, Gregg EW. Prevalence of diabetes and impaired fasting glucose in adults in the U.S. population: National Health And Nutrition Examination Survey 1999-2002. Diabetes Care. 2006 Jun;29(6):1263-8. doi: 10.2337/dc06-0062. PubMed 16732006 ↗
  • American Diabetes Association. Economic costs of diabetes in the U.S. In 2007. Diabetes Care. 2008 Mar;31(3):596-615. doi: 10.2337/dc08-9017. PubMed 18308683 ↗
  • American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available. PubMed 18165335 ↗
  • Ehrenkranz JR, Lewis NG, Kahn CR, Roth J. Phlorizin: a review. Diabetes Metab Res Rev. 2005 Jan-Feb;21(1):31-8. doi: 10.1002/dmrr.532. PubMed 15624123 ↗
  • Han S, Hagan DL, Taylor JR, Xin L, Meng W, Biller SA, Wetterau JR, Washburn WN, Whaley JM. Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats. Diabetes. 2008 Jun;57(6):1723-9. doi: 10.2337/db07-1472. Epub 2008 Mar 20. PubMed 18356408 ↗
  • Jabbour SA, Goldstein BJ. Sodium glucose co-transporter 2 inhibitors: blocking renal tubular reabsorption of glucose to improve glycaemic control in patients with diabetes. Int J Clin Pract. 2008 Aug;62(8):1279-84. doi: 10.1111/j.1742-1241.2008.01829.x. PubMed 18705823 ↗
  • Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009 May;85(5):513-9. doi: 10.1038/clpt.2008.250. Epub 2009 Jan 7. PubMed 19129749 ↗
  • Krook A, Kawano Y, Song XM, Efendic S, Roth RA, Wallberg-Henriksson H, Zierath JR. Improved glucose tolerance restores insulin-stimulated Akt kinase activity and glucose transport in skeletal muscle from diabetic Goto-Kakizaki rats. Diabetes. 1997 Dec;46(12):2110-4. doi: 10.2337/diab.46.12.2110. PubMed 9392506 ↗
  • Oku A, Ueta K, Arakawa K, Ishihara T, Nawano M, Kuronuma Y, Matsumoto M, Saito A, Tsujihara K, Anai M, Asano T, Kanai Y, Endou H. T-1095, an inhibitor of renal Na+-glucose cotransporters, may provide a novel approach to treating diabetes. Diabetes. 1999 Sep;48(9):1794-800. doi: 10.2337/diabetes.48.9.1794. PubMed 10480610 ↗
  • Pajor AM, Wright EM. Cloning and functional expression of a mammalian Na+/nucleoside cotransporter. A member of the SGLT family. J Biol Chem. 1992 Feb 25;267(6):3557-60. PubMed 1740408 ↗
  • Santer R, Kinner M, Lassen CL, Schneppenheim R, Eggert P, Bald M, Brodehl J, Daschner M, Ehrich JH, Kemper M, Li Volti S, Neuhaus T, Skovby F, Swift PG, Schaub J, Klaerke D. Molecular analysis of the SGLT2 gene in patients with renal glucosuria. J Am Soc Nephrol. 2003 Nov;14(11):2873-82. doi: 10.1097/01.asn.0000092790.89332.d2. PubMed 14569097 ↗
  • Toggenburger G, Kessler M, Semenza G. Phlorizin as a probe of the small-intestinal Na+,D-glucose cotransporter. A model. Biochim Biophys Acta. 1982 Jun 14;688(2):557-71. doi: 10.1016/0005-2736(82)90367-4. PubMed 7201854 ↗
  • Tsujihara K, Hongu M, Saito K, Inamasu M, Arakawa K, Oku A, Matsumoto M. Na(+)-glucose cotransporter inhibitors as antidiabetics. I. Synthesis and pharmacological properties of 4'-dehydroxyphlorizin derivatives based on a new concept. Chem Pharm Bull (Tokyo). 1996 Jun;44(6):1174-80. doi: 10.1248/cpb.44.1174. PubMed 8814948 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00924053
Lead sponsor
Theracos
Responsible party
Sponsor
First posted
Jun 18, 2009
Start date
Jun 2009
Primary completion
Jul 2009
Completion
Jul 2009
Results posted
Aug 17, 2011
Last update
Jun 17, 2019

Study contacts

Mason W. Freeman, M.D.
study chair · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2 →

Other studies from this sponsor

Theracos

Start the discussion