Phase 2
Completed N=149
Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01029704 ↗Enrolled (actual)
149
Serious AEs
1.3%
Results posted
Jul 2011
Primary outcomePrimary: Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study — -12.595; -29.518; -30.429; -32.586 mg/dL — p=0.0989
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study |
-12.595; -29.518; -30.429; -32.586; -44.605 | 0.0989 |
| PRIMARY Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4 |
40.42; 83.38; 164.20; 541.20 | — |
| PRIMARY Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 |
334.02; 681.88; 1312.36; 3308.88; 328.85; 548.15 | — |
| SECONDARY Change in the Body Weight From Baseline at Week 4 |
0.258; -1.176; -0.779; -1.796; -0.914 | 0.0025 sig |
| SECONDARY Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 |
0.178; -0.176; 0.022; 0.173; -0.167 | 0.0281 sig |
| SECONDARY Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 |
-3.55; 26.21; 24.17; 25.13; 29.61; -0.20 | — |
| SECONDARY Change in FPG Following Cessation of Treatment |
0.058; 17.746; 17.148; 24.437; 20.807 | 0.1613 |
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.
Data sourced from ClinicalTrials.gov (NCT01029704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.