Diabetes Mellitus Type 2Phase 2NCT01029704

Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus

A Phase 2 study testing EGT0001442 in people with Diabetes Mellitus Type 2, run by Theracos at 12 sites in 2 countries.

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 was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes. The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount… 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?: EGT0001442
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 151 participants
Where: 12 sitesin 2 countries
Study dates: Dec 2009to Jul 2010
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).
If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
Female subjects must be surgically sterilized or postmenopausal.

Who cannot join

Type 1 diabetes or diabetes treated with insulin injection.
Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
Positive results on screen for drugs of abuse.
Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
Previous treatment with EGT0001474 or EGT0001442.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States9 sites

Research Site #10
Birmingham, Alabama
Research Site #12
Denver, Colorado
Research Site #11
DeSoto, Texas
Research Site #07
Miami, Florida
Research Site #08
Miami, Florida
Research Site #04
National City, California
Research Site #06
Reading, Pennsylvania
Research Site #01
San Antonio, Texas
Research Site #15
San Antonio, Texas

Other trials in United States

Canada3 sites

Research Site #03
Brampton, Ontario
Research Site #13
London, Ontario
Research Site #02
Mississauga, Ontario

Other trials in Canada

About this study

Official title: A Phase II, Four-week, Multi-center, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Safety and Efficacy of EGT0001442 in Subjects With Type 2 Diabetes Mellitus With an Ascending Dose Safety and Pharmacokinetic Evaluation Period

The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.

The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.

Read the detailed description

This was a phase 2 study to evaluate the efficacy of

EGT0001442. The study included two segments:

Segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.

Segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.

Conditions: Diabetes Mellitus Type 2
Being tested: EGT0001442, Placebo capsules to match EGT0001442
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.

EGT0001442Drug
Also called Human SGLT2 inhibitor
Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.
Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.
Placebo capsules to match EGT0001442Drug
Also called Human SGLT2 inhibitor
Segment 1: Not applicable.
Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.

Study groups in NCT01029704
Study group	Role	What they receive
EGT0001442	Experimental	Not described Receives: Drug: EGT0001442
Placebo	Placebo comparator	Not described Receives: Drug: Placebo capsules to match EGT0001442

What is being measured

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

Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study
Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.
Measured: Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29
Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Measured: Pre-dose to 48 h post-dose
Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Measured: Pre-dose to 48 h post-dose

Secondary outcomes (4)

Change in the Body Weight From Baseline at Week 4
Changes in the body weight during the study period was calculated by subtracting body weight on day 1 from body weight at the end of treatment on day 29.
Measured: Baseline and Day 29
Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4
HbA1c levels were measured at two time points; on day 1 and day 29 (end of treatment). Changes in the HbA1c level during the study period was calculated by subtracting HbA1c level on day 1 from HbA1c level at the end of treatment (day 29)
Measured: Baseline and Day 29
Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28
Urinary glucose levels were measured at three time points; on Day 0 (baseline), Day 1 and Day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (Day 1) from urinary glucose level at end of treatment (Day 28) (i.e urinary glucose level on Day 28 minus urinary glucose level on Day 1).
Measured: Baseline, Day 1 and Day 28
Change in FPG Following Cessation of Treatment
The mean change in FPG following cessation of treatment was obtained by calculating the difference between FPG values obtained on End of treatment (average of FPG values on days 27 and 29) and on Post Treatment (average of FPG values on days 41 and 43).
Measured: Days 27/29 to Days 41/43

Timeline

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

Dec 2009Jul 2010

First posted10 Dec 2009 (estimated)
Study startDec 2009
Primary completionJul 2010
Study completionJul 2010

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01029704
Sponsor's protocol ID: THR-1442-C-402
Status last verified: Jun 2021
First submitted: 9 Dec 2009
Last updated: 16 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Four-week, Multi-center, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Safety and Efficacy of EGT0001442 in Subjects With Type 2 Diabetes Mellitus With an Ascending Dose Safety and Pharmacokinetic Evaluation Period
ClinicalTrials.gov ID: NCT01029704
Acronym / sponsor ID: THR-1442-C-402
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 151 participants (actual)
Lead sponsor: TheracosIndustry (pharma, biotech, devices)
Study start: Dec 2009 (actual)
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 10 Dec 2009 (estimated)
Results: Posted 20 Jul 2011

Clinical summary

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

The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.

Detailed description

This was a phase 2 study to evaluate the efficacy of

EGT0001442. The study included two segments:

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
EGT0001442	Experimental	Drug: EGT0001442
Placebo	Placebo comparator	Drug: Placebo capsules to match EGT0001442

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 female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).

Key exclusion criteria (6 listed)

Type 1 diabetes or diabetes treated with insulin injection.
Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
Positive results on screen for drugs of abuse.
Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.

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
EGT0001442Also: Human SGLT2 inhibitorSegment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.	Drug	EGT0001442
Placebo capsules to match EGT0001442Also: Human SGLT2 inhibitorSegment 1: Not applicable. Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.	Drug	Placebo

Primary outcome

Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study
Time frame: Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29
Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.
Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4
Time frame: Pre-dose to 48 h post-dose
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4
Time frame: Pre-dose to 48 h post-dose
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.

4 secondary outcomes

Change in the Body Weight From Baseline at Week 4
Time frame: Baseline and Day 29
Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4
Time frame: Baseline and Day 29
Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28
Time frame: Baseline, Day 1 and Day 28
Change in FPG Following Cessation of Treatment
Time frame: Days 27/29 to Days 41/43

Results and safety

Results posted to the registry on 20 Jul 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
Segment 1 (Dose Escalation): EGT0001442 5mg	5	5
Segment 1 (Dose Escalation): EGT0001442 10mg	5	5
Segment 1 (Dose Escalation): EGT0001442 20mg	5	5
Segment 1 (Dose Escalation): EGT0001442 50mg	5	5
Segment 2 (Double-blind): Placebo	28	23
Segment 2 (Double-blind): EGT0001442 5mg	24	20
Segment 2 (Double-blind): EGT0001442 10mg	23	19
Segment 2 (Double-blind): EGT0001442 20mg	28	22
Segment 2 (Double-blind): EGT0001442 50mg	26	25

Primary outcome: Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study

Time frame: Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29. Least squares mean (Standard Error). Unit: mg/dL

Measure	Placebo n = 28	EGT0001442 5mg n = 24	EGT0001442 10mg n = 23	EGT0001442 20mg n = 28	EGT0001442 50mg n = 26
Value	-12.595 (7.025)	-29.518 (7.767)	-30.429 (8.386)	-32.586 (7.305)	-44.605 (7.299)

Placebo vs EGT0001442 5mg: Difference of LS Means: -16.923 (95% CI -37.076 to 3.230), p = 0.0989, ANCOVA
Placebo vs EGT0001442 10mg: Difference of LS Means: -17.834 (95% CI -38.909 to 3.242), p = 0.0964, ANCOVA
Placebo vs EGT0001442 20mg: Difference of LS Means: -19.991 (95% CI -39.670 to -0.312), p = 0.0465, ANCOVA

Population analysed: Subjects participated in Segment 2 of the study were included in the analysis.

Primary outcome: Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4

Time frame: Pre-dose to 48 h post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Segment 1 (Dose Escalation): EGT0001442 5mg n = 5	Segment 1 (Dose Escalation): EGT0001442 10mg n = 5	Segment 1 (Dose Escalation): EGT0001442 20mg n = 5	Segment 1 (Dose Escalation): EGT0001442 50mg n = 5
Value	40.42 (15.21)	83.38 (30.93)	164.20 (40.21)	541.20 (192.20)

Population analysed: 20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2.

Primary outcome: Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4

Time frame: Pre-dose to 48 h post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Segment 1 (Dose Escalation): EGT0001442 5mg n = 5	Segment 1 (Dose Escalation): EGT0001442 10mg n = 5	Segment 1 (Dose Escalation): EGT0001442 20mg n = 5	Segment 1 (Dose Escalation): EGT0001442 50mg n = 5
AUC0-t	334.02 (51.80)	681.88 (74.66)	1312.36 (487.28)	3308.88 (785.59)
AUC0-24	328.85 (56.07)	548.15 (70.41)	1076.39 (373.15)	2755.68 (586.08)

Population analysed: 20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2. AUC0-24 values for two participants in 5 mg arm were not calculated.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Segment 1 (Dose Escalation): EGT0001442 5mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Segment 1 (Dose Escalation): EGT0001442 10mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Segment 1 (Dose Escalation): EGT0001442 20mg	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Segment 1 (Dose Escalation): EGT0001442 50mg	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Placebo	0 of 28 (0%)	4 of 28 (14.3%)	0 of 28
EGT0001442 5mg	1 of 24 (4.2%)	3 of 24 (12.5%)	0 of 24
EGT0001442 10mg	1 of 23 (4.3%)	6 of 23 (26.1%)	0 of 23
EGT0001442 20mg	0 of 28 (0%)	6 of 28 (21.4%)	0 of 28
EGT0001442 50mg	0 of 26 (0%)	6 of 26 (23.1%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EGT0001442 in people with Diabetes Mellitus Type 2, run by Theracos at 12 sites in 2 countries.

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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. 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 20 Jul 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?

Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study (time frame: Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29). The study lists 3 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 NCT01029704.

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 16 Jun 2021.