Diabetes Mellitus Type 2Phase 1NCT00924053

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

A Phase 1 study testing EGT0001474 in people with Diabetes Mellitus Type 2, run by Theracos at 1 site in United States.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: EGT0001474
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Jul 2009
Phase: Phase 1
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

dgd Research Inc., a Cetero Research Company
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of EGT0001474 in Subjects With Type 2 Diabetes

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).

Conditions: Diabetes Mellitus Type 2
Being tested: EGT0001474, Placebo
Keywords: Diabetes Mellitus Type 2
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

EGT0001474Drug
Also called Human SGLT2 inhibitor
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.
PlaceboDrug
Also called Human SGLT2 inhibitor
Placebo capsules to match EGT0001474

Study groups in NCT00924053
Study group	Role	What they receive
EGT0001474	Experimental	Not described Receives: Drug: EGT0001474
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

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.
Measured: 25 days
AUC 0-t
Area under the plasma concentration-time curve from time 0 to time t
Measured: 3 days
AUC0-24
Area under the plasma concentration-time curve from time 0 to hour 24
Measured: 3 days
AUC Inf
Area under the plasma concentration-time curve from time 0 to infinity
Measured: 3 days
Cmax
Maximum plasma concentration
Measured: 3 days
Tmax
Time of maximum plasma concentration
Measured: 3 days
λz
Terminal phase rate constant
Measured: 3 days
t1/2
Apparent terminal half life
Measured: 3 days
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.
Measured: 3 days
Vz/F
Apparent volume of distribution
Measured: 3 days

Timeline

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

Jun 2009Jul 2009

First posted18 Jun 2009 (estimated)
Study startJun 2009
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00924053
Sponsor's protocol ID: THR-1474-C-396
Status last verified: Jun 2019
First submitted: 16 Jun 2009
Last updated: 17 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of EGT0001474 in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00924053
Acronym / sponsor ID: THR-1474-C-396
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: TheracosIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 18 Jun 2009 (estimated)
Results: Posted 17 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
EGT0001474	Experimental	Drug: EGT0001474
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EGT0001474Also: Human SGLT2 inhibitorCohort 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.	Drug	EGT0001474
PlaceboAlso: Human SGLT2 inhibitorPlacebo capsules to match EGT0001474	Drug	Placebo

Primary outcome

Safety and Tolerability of EGT0001474
Time frame: 25 days
Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.
AUC 0-t
Time frame: 3 days
Area under the plasma concentration-time curve from time 0 to time t
AUC0-24
Time frame: 3 days
Area under the plasma concentration-time curve from time 0 to hour 24
AUC Inf
Time frame: 3 days
Area under the plasma concentration-time curve from time 0 to infinity
Cmax
Time frame: 3 days
Maximum plasma concentration
Tmax
Time frame: 3 days
Time of maximum plasma concentration
λz
Time frame: 3 days
Terminal phase rate constant
t1/2
Time frame: 3 days
Apparent terminal half life
CL/F
Time frame: 3 days
The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.
Vz/F
Time frame: 3 days
Apparent volume of distribution

Results and safety

Results posted to the registry on 17 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	6	6
EGT0001474 25 mg	6	6
EGT0001474 75 mg	6	6
EGT0001474 150mg	6	6

Primary outcome: Safety and Tolerability of EGT0001474

Time frame: 25 days. Number. Unit: Events

Measure	Placebo n = 6	EGT0001474 75 mg n = 6	EGT0001474 150mg n = 6
Mild adverse events	5	9	3
Moderate adverse events	0	0	1
Serious adverse events	0	0	0

Population analysed: All patients who took study medication were included in the analysis.

Primary outcome: AUC 0-t

Time frame: 3 days. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Placebo n = 6	EGT0001474 25 mg n = 6	EGT0001474 75 mg n = 6	EGT0001474 150mg n = 6
Value	NA (NA)	1103.89 (470.31)	3370.29 (499.36)	6177.8 (1691.04)

Primary outcome: AUC0-24

Time frame: 3 days. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Placebo n = 6	EGT0001474 25 mg n = 6	EGT0001474 75 mg n = 6	EGT0001474 150mg n = 6
Value	NA (NA)	987.3 (368.21)	2990.63 (461.18)	5584.72 (1516.64)

Primary outcome: AUC Inf

Time frame: 3 days. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Placebo n = 6	EGT0001474 25 mg n = 6	EGT0001474 75 mg n = 6	EGT0001474 150mg n = 6
Value	NA (NA)	1165.59 (479.88)	3532.02 (524.74)	6399.55 (1736.38)

Adverse events

Time frame: 25 days total (14 day washout, 4 days in study, 1 week follow up after dosing). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
EGT0001474 25 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
EGT0001474 75 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
EGT0001474 150mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 2198430Blondel 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.
Background: PubMed 16732006Cowie 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.
Background: PubMed 18308683American 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.
Background: PubMed 18165335American 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.
Background: PubMed 15624123Ehrenkranz 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.
Background: PubMed 18356408Han 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.
Background: PubMed 18705823Jabbour 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.
Background: PubMed 19129749Komoroski 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.
Background: PubMed 9392506Krook 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.
Background: PubMed 10480610Oku 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.
Background: PubMed 1740408Pajor 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.
Background: PubMed 14569097Santer 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mason W. Freeman, M.D. study chair

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EGT0001474 in people with Diabetes Mellitus Type 2, run by Theracos at 1 site 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 7 inclusion and 6 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 17 Aug 2011). 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?

Safety and Tolerability of EGT0001474 (time frame: 25 days). The study lists 10 primary outcomes in all. 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 NCT00924053, which also lists 14 linked publications.

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 17 Jun 2019.