Diabetes Mellitus Type 2
Conditions
Keywords
Diabetes Mellitus Type 2
Brief 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 of glucose produced in the body by the urine.
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.
Interventions
DRUGEGT0001442
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.
DRUGPlacebo capsules to match EGT0001442
Segment 1: Not applicable. Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.
Sponsors
Theracos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Body Weight From Baseline at Week 4 | Baseline and Day 29 | 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. |
| Change in FPG Following Cessation of Treatment | Days 27/29 to Days 41/43 | 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). |
| Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 | Baseline and Day 29 | 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) |
| Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Baseline, 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). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Segment 1 (Dose Escalation): EGT0001442 5mg Received 5mg of EGT0001442 once daily for 28 days | 5 |
| Segment 1 (Dose Escalation): EGT0001442 10mg Received 10mg of EGT0001442 once daily for 28 days | 5 |
| Segment 1 (Dose Escalation): EGT0001442 20mg Received 20mg of EGT0001442 once daily for 28 days | 5 |
| Segment 1 (Dose Escalation): EGT0001442 50mg Received 50mg of EGT0001442 once daily for 28 days | 5 |
| Segment 2 (Double-blind): Placebo Received placebo once daily for 28 days | 28 |
| Segment 2 (Double-blind): EGT0001442 5mg Received 5mg of EGT0001442 once daily for 28 days | 24 |
| Segment 2 (Double-blind): EGT0001442 10mg Received 10mg of EGT0001442 once daily for 28 days | 23 |
| Segment 2 (Double-blind): EGT0001442 20mg Received 20mg of EGT0001442 once daily for 28 days | 28 |
| Segment 2 (Double-blind): EGT0001442 50mg Received 50mg of EGT0001442 once daily for 28 days | 26 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 2 | 3 | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 1 | 0 |
| Overall Study | Withdrawn due to major protocol violation | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Segment 1 (Dose Escalation): EGT0001442 50mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 2 (Double-blind): Placebo | Segment 2 (Double-blind): EGT0001442 5mg | Segment 2 (Double-blind): EGT0001442 10mg | Segment 2 (Double-blind): EGT0001442 20mg | Segment 2 (Double-blind): EGT0001442 50mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Segment 1 | 54.1 years STANDARD_DEVIATION 10.8 | 53.2 years STANDARD_DEVIATION 5.8 | 51.4 years STANDARD_DEVIATION 11.7 | 49.4 years STANDARD_DEVIATION 14.2 | 62.2 years STANDARD_DEVIATION 7.9 | — | — | — | — | — |
| Age, Continuous Segment 2 | 57.1 years STANDARD_DEVIATION 7.5 | — | — | — | — | 58.7 years STANDARD_DEVIATION 7.3 | 57.8 years STANDARD_DEVIATION 6.9 | 54.9 years STANDARD_DEVIATION 9 | 59 years STANDARD_DEVIATION 7.1 | 54.7 years STANDARD_DEVIATION 6.7 |
| BMI Segment 1 | 30.98 kg/m2 STANDARD_DEVIATION 3.4 | 29.14 kg/m2 STANDARD_DEVIATION 2.94 | 34.18 kg/m2 STANDARD_DEVIATION 3.58 | 30.00 kg/m2 STANDARD_DEVIATION 3.39 | 30.58 kg/m2 STANDARD_DEVIATION 1.85 | — | — | — | — | — |
| BMI Segment 2 | 29.70 kg/m2 STANDARD_DEVIATION 3.77 | — | — | — | — | 29.77 kg/m2 STANDARD_DEVIATION 3.03 | 29.96 kg/m2 STANDARD_DEVIATION 3.98 | 28.91 kg/m2 STANDARD_DEVIATION 4.02 | 29.10 kg/m2 STANDARD_DEVIATION 3.3 | 30.75 kg/m2 STANDARD_DEVIATION 4.47 |
| Ethnicity (NIH/OMB) Segment 1 Hispanic or Latino | 15 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Segment 1 Not Hispanic or Latino | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Segment 1 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Segment 2 Hispanic or Latino | 89 Participants | — | — | — | — | 20 Participants | 16 Participants | 15 Participants | 19 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Segment 2 Not Hispanic or Latino | 40 Participants | — | — | — | — | 8 Participants | 8 Participants | 8 Participants | 9 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Segment 2 Unknown or Not Reported | 0 Participants | — | — | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height Segment 1 | 168.98 cm STANDARD_DEVIATION 10.2 | 172.80 cm STANDARD_DEVIATION 9 | 163.74 cm STANDARD_DEVIATION 9.1 | 167.34 cm STANDARD_DEVIATION 11.42 | 172.04 cm STANDARD_DEVIATION 11.49 | — | — | — | — | — |
| Height Segment 2 | 167.36 cm STANDARD_DEVIATION 10.19 | — | — | — | — | 167.76 cm STANDARD_DEVIATION 11.09 | 170.15 cm STANDARD_DEVIATION 9.32 | 167.50 cm STANDARD_DEVIATION 9.83 | 166.71 cm STANDARD_DEVIATION 9.6 | 164.92 cm STANDARD_DEVIATION 10.98 |
| Race (NIH/OMB) Segment 1 American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 1 Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 1 Black or African American | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 1 More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 1 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 1 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 1 White | 18 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 2 American Indian or Alaska Native | 0 Participants | — | — | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 2 Asian | 15 Participants | — | — | — | — | 5 Participants | 2 Participants | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Segment 2 Black or African American | 6 Participants | — | — | — | — | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Segment 2 More than one race | 2 Participants | — | — | — | — | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Segment 2 Native Hawaiian or Other Pacific Islander | 0 Participants | — | — | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 2 Unknown or Not Reported | 0 Participants | — | — | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Segment 2 White | 106 Participants | — | — | — | — | 21 Participants | 20 Participants | 19 Participants | 22 Participants | 24 Participants |
| Sex: Female, Male Segment 1 Female | 6 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Segment 1 Male | 14 Participants | 4 Participants | 2 Participants | 4 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Segment 2 Female | 62 Participants | — | — | — | — | 11 Participants | 9 Participants | 12 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Segment 2 Male | 67 Participants | — | — | — | — | 17 Participants | 15 Participants | 11 Participants | 16 Participants | 8 Participants |
| Weight Segment 1 | 88.54 kg STANDARD_DEVIATION 13.01 | 87.22 kg STANDARD_DEVIATION 12.81 | 92.18 kg STANDARD_DEVIATION 16.65 | 83.72 kg STANDARD_DEVIATION 9.86 | 91.04 kg STANDARD_DEVIATION 14.48 | — | — | — | — | — |
| Weight Segment 2 | 83.51 kg STANDARD_DEVIATION 14.86 | — | — | — | — | 84.34 kg STANDARD_DEVIATION 15.83 | 86.75 kg STANDARD_DEVIATION 13.53 | 81.40 kg STANDARD_DEVIATION 15.03 | 81.03 kg STANDARD_DEVIATION 12.17 | 84.18 kg STANDARD_DEVIATION 17.61 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 28 | 0 / 24 | 0 / 23 | 0 / 28 | 0 / 26 |
| other Total, other adverse events | 3 / 5 | 3 / 5 | 3 / 5 | 2 / 5 | 4 / 28 | 3 / 24 | 6 / 23 | 6 / 28 | 6 / 26 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 28 | 1 / 24 | 1 / 23 | 0 / 28 | 0 / 26 |
Outcome results
Primary
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.
Time frame: Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29
Population: Subjects participated in Segment 2 of the study were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study | -12.595 mg/dL | Standard Error 7.025 |
| EGT0001442 5mg | Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study | -29.518 mg/dL | Standard Error 7.767 |
| EGT0001442 10mg | Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study | -30.429 mg/dL | Standard Error 8.386 |
| EGT0001442 20mg | Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study | -32.586 mg/dL | Standard Error 7.305 |
| EGT0001442 50mg | Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study | -44.605 mg/dL | Standard Error 7.299 |
p-value: 0.098995% CI: [-37.076, 3.23]ANCOVA
p-value: 0.096495% CI: [-38.909, 3.242]ANCOVA
p-value: 0.046595% CI: [-39.67, -0.312]ANCOVA
p-value: 0.001595% CI: [-51.487, -12.533]ANCOVA
Primary
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.
Time frame: Pre-dose to 48 h post-dose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 | AUC0-t | 334.02 ng*h/mL | Standard Deviation 51.8 |
| Placebo | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 | AUC0-24 | 328.85 ng*h/mL | Standard Deviation 56.07 |
| EGT0001442 5mg | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 | AUC0-24 | 548.15 ng*h/mL | Standard Deviation 70.41 |
| EGT0001442 5mg | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 | AUC0-t | 681.88 ng*h/mL | Standard Deviation 74.66 |
| EGT0001442 10mg | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 | AUC0-t | 1312.36 ng*h/mL | Standard Deviation 487.28 |
| EGT0001442 10mg | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 | AUC0-24 | 1076.39 ng*h/mL | Standard Deviation 373.15 |
| EGT0001442 20mg | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 | AUC0-t | 3308.88 ng*h/mL | Standard Deviation 785.59 |
| EGT0001442 20mg | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 | AUC0-24 | 2755.68 ng*h/mL | Standard Deviation 586.08 |
Primary
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.
Time frame: Pre-dose to 48 h post-dose
Population: 20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4 | 40.42 ng/mL | Standard Deviation 15.21 |
| EGT0001442 5mg | Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4 | 83.38 ng/mL | Standard Deviation 30.93 |
| EGT0001442 10mg | Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4 | 164.20 ng/mL | Standard Deviation 40.21 |
| EGT0001442 20mg | Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4 | 541.20 ng/mL | Standard Deviation 192.2 |
Secondary
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).
Time frame: Days 27/29 to Days 41/43
Population: Subjects participated in Segment 2 of the study and had fasting plasma glucose (FPG) values at the end of treatment (mean FPG value on days 27 and 29) and at post-treatment (mean FPG values on days 41 and 43) are included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in FPG Following Cessation of Treatment | 0.058 mg/dL | Standard Error 8.256 |
| EGT0001442 5mg | Change in FPG Following Cessation of Treatment | 17.746 mg/dL | Standard Error 8.896 |
| EGT0001442 10mg | Change in FPG Following Cessation of Treatment | 17.148 mg/dL | Standard Error 10.421 |
| EGT0001442 20mg | Change in FPG Following Cessation of Treatment | 24.437 mg/dL | Standard Error 7.989 |
| EGT0001442 50mg | Change in FPG Following Cessation of Treatment | 20.807 mg/dL | Standard Error 8.021 |
p-value: 0.161395% CI: [-7.21, 42.587]ANCOVA
p-value: 0.207995% CI: [-9.696, 43.877]ANCOVA
p-value: 0.04195% CI: [1.028, 47.731]ANCOVA
p-value: 0.086295% CI: [-3.019, 44.518]ANCOVA
Secondary
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.
Time frame: Baseline and Day 29
Population: Subjects participated in Segment 2 of the study were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in the Body Weight From Baseline at Week 4 | 0.258 Kg | Standard Error 0.304 |
| EGT0001442 5mg | Change in the Body Weight From Baseline at Week 4 | -1.176 Kg | Standard Error 0.345 |
| EGT0001442 10mg | Change in the Body Weight From Baseline at Week 4 | -0.779 Kg | Standard Error 0.346 |
| EGT0001442 20mg | Change in the Body Weight From Baseline at Week 4 | -1.796 Kg | Standard Error 0.324 |
| EGT0001442 50mg | Change in the Body Weight From Baseline at Week 4 | -0.914 Kg | Standard Error 0.315 |
p-value: 0.002595% CI: [-2.349, -0.52]ANCOVA
p-value: 0.026995% CI: [-1.952, -0.122]ANCOVA
p-value: <0.000195% CI: [-2.938, -1.17]ANCOVA
p-value: 0.00995% CI: [-2.044, -0.301]ANCOVA
Secondary
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).
Time frame: Baseline, Day 1 and Day 28
Population: Only number of subjects with data available in the specific treatment group is included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 1 | -3.55 g/24h | Standard Deviation 13.05 |
| Placebo | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 28 | -0.20 g/24h | Standard Deviation 14.98 |
| EGT0001442 5mg | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 1 | 26.21 g/24h | Standard Deviation 11.08 |
| EGT0001442 5mg | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 28 | 22.57 g/24h | Standard Deviation 16.56 |
| EGT0001442 10mg | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 1 | 24.17 g/24h | Standard Deviation 16.89 |
| EGT0001442 10mg | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 28 | 18.71 g/24h | Standard Deviation 20.46 |
| EGT0001442 20mg | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 28 | 21.01 g/24h | Standard Deviation 16.43 |
| EGT0001442 20mg | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 1 | 25.13 g/24h | Standard Deviation 12.72 |
| EGT0001442 50mg | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 1 | 29.61 g/24h | Standard Deviation 20 |
| EGT0001442 50mg | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 | Change in 24 h UGE from baseline to Day 28 | 26.80 g/24h | Standard Deviation 19.36 |
Secondary
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)
Time frame: Baseline and Day 29
Population: Subjects participated in Segment 2 of the study were included in the analysis.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 | 0.178 percentage of HbA1c | Standard Error 0.107 |
| EGT0001442 5mg | Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 | -0.176 percentage of HbA1c | Standard Error 0.122 |
| EGT0001442 10mg | Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 | 0.022 percentage of HbA1c | Standard Error 0.123 |
| EGT0001442 20mg | Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 | 0.173 percentage of HbA1c | Standard Error 0.115 |
| EGT0001442 50mg | Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 | -0.167 percentage of HbA1c | Standard Error 0.112 |
p-value: 0.028195% CI: [-0.668, -0.039]ANCOVA
p-value: 0.321595% CI: [-0.464, 0.154]ANCOVA
p-value: 0.977695% CI: [-0.304, 0.295]ANCOVA
p-value: 0.024295% CI: [-0.642, -0.046]ANCOVA