Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus - Full Text View

Purpose

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

The study will also assess the pharmacokinetics (how much of the drug gets into the blood and how long it takes the body to get rid of it), 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.

Condition	Intervention	Phase
Diabetes Mellitus Type 2	Drug: EGT0001442 Drug: Placebo capsules to match EGT0001442	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Type 2 Diabetic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Theracos:

Primary Outcome Measures:

Changes From the Baseline in the Fasting Plasma Glucose at End of 28 Days [ Time Frame: baseline (day 1) and 28 days ] [ Designated as safety issue: No ]
Fasting glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the fasting plasma glucose level during the study period was calculated by reducing the baseline glucose level (day 1) from glucose level at end of treatment (day 28) (i.e glucose level on day 28 minus glucose level on Day 1).

Secondary Outcome Measures:

Change From the Baseline in the Body Weight at End of 28 Days [ Time Frame: baseline (day 1) and 28 days ] [ Designated as safety issue: No ]
Body weight was measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the body weight during the study period was calculated by reducing the baseline body weight (day 1) from body weight at end of treatment (day 28) (i.e body weight on day 28 minus body weight on Day 1).
Changes From the Baseline in the Hemoglobin A1c (HbA1c) at End of 28 Days [ Time Frame: baseline (day 1) and 28 days ] [ Designated as safety issue: No ]
HbA1c levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the HbA1c level during the study period was calculated by reducing the baseline HbA1c level (day 1) from HbA1c level at end of treatment (day 28) (i.e HbA1c level on day 28 minus HbA1c level on Day 1).
Changes From the Baseline in the Urinary Glucose Excretion at End of 28 Days [ Time Frame: baseline (day 1) and 28 days ] [ Designated as safety issue: No ]
Urinary glucose levels were measured at two time points; on day 1 (baseline) 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).

Enrollment:	129
Study Start Date:	December 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: EGT0001442	Drug: EGT0001442 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. Other Name: Human SGLT2 inhibitor
Placebo Comparator: Placebo	Drug: Placebo 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. Other Name: Human SGLT2 inhibitor

Arms

Assigned Interventions

Experimental: EGT0001442

Drug: EGT0001442

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.

Other Name: Human SGLT2 inhibitor

Placebo Comparator: Placebo

Drug: Placebo 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.

Other Name: Human SGLT2 inhibitor

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029704

Locations

United States, Alabama
Research Site #10
Birmingham, Alabama, United States
United States, California
Research Site #04
National City, California, United States
United States, Colorado
Research Site #12
Denver, Colorado, United States
United States, Florida
Research Site #07
Miami, Florida, United States
Research Site #08
Miami, Florida, United States
United States, Pennsylvania
Research Site #06
Reading, Pennsylvania, United States
United States, Texas
Research Site #11
Desoto, Texas, United States
Research Site #01
San Antonio, Texas, United States
Research Site #15
San Antonio, Texas, United States
Canada, Ontario
Research Site #03
Brampton, Ontario, Canada
Research Site #13
London, Ontario, Canada
Research Site #02
Mississauga, Ontario, Canada

Sponsors and Collaborators

Theracos

Investigators

Study Chair:

Mason W Freeman, M.D.

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Albert Collinson, PhD, Chief Executive Officer, Theracos Inc.
ClinicalTrials.gov Identifier:	NCT01029704 History of Changes
Other Study ID Numbers:	THR-1442-C-402
Study First Received:	December 9, 2009
Results First Received:	June 21, 2011
Last Updated:	July 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theracos:

Diabetes Mellitus Type 2

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013