Clinical trial NCT01029704: Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Lead sponsor: Theracos
Sponsor class: INDUSTRY
First posted: 2009-12-10
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study
timeFrame: Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29
measure: Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4
timeFrame: Pre-dose to 48 h post-dose
measure: Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4
timeFrame: Pre-dose to 48 h post-dose
Secondary outcomes:
measure: Change in the Body Weight From Baseline at Week 4
timeFrame: Baseline and Day 29
measure: Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4
timeFrame: Baseline and Day 29
measure: Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28
timeFrame: Baseline, Day 1 and Day 28
measure: Change in FPG Following Cessation of Treatment
timeFrame: Days 27/29 to Days 41/43
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site #10
state: Alabama
city: National City
country: United States
facility: Research Site #04
state: California
city: Denver
country: United States
facility: Research Site #12
state: Colorado
city: Miami
country: United States
facility: Research Site #07
state: Florida
city: Miami
country: United States
facility: Research Site #08
state: Florida
city: Reading
country: United States
facility: Research Site #06
state: Pennsylvania
city: DeSoto
country: United States
facility: Research Site #11
state: Texas
city: San Antonio
country: United States
facility: Research Site #01
state: Texas
city: San Antonio
country: United States
facility: Research Site #15
state: Texas
city: Brampton
country: Canada
facility: Research Site #03
state: Ontario
city: London
country: Canada
facility: Research Site #13
state: Ontario
city: Mississauga
country: Canada
facility: Research Site #02
state: Ontario
Study officials:
affiliation: Massachusetts General Hospital
name: Mason W Freeman, M.D.
role: STUDY_CHAIR
References: