Phase 2
Completed N=36
Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00962065 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion — 35.729; 47.085; -0.965 grams
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion |
35.729; 47.085; -0.965 | — |
| SECONDARY Change From Baseline at Day 29 in Fasting Plasma Glucose |
-52.3; -67.8; -12.3 | — |
| SECONDARY Change From Baseline at Day 28 in Plasma HbA1c |
-1.15; -1.25; -0.49 | — |
| SECONDARY Change From Baseline at Day 28 in Plasma Fructosamine Level |
-24.5; -24.9; 18.1 | — |
| SECONDARY Change From Baseline at Day 28 in Mean Arterial Pressure |
-8.6; -5.6; -3.8; -7.3; -7.9; -3.4 | — |
| SECONDARY Change From Baseline at Day 28 in Triglycerides |
-66.6; -62.8; -20.2 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females (non-childbearing potential), aged 18-65 years
- Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening
- Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout
- Body mass index < 42 kg/m^2
- HbA1c value of 7 to 11%
- C-peptide ≥ 1.0 ng/mL
- Ability to provide written informed consent
Exclusion Criteria
- History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
- Use of any blood glucose lowering agent other than metformin
- Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
- Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator
- Positive test result for glutamic acid decarboxylase (GAD) antibody
- Surgery within 6 months of screening
- Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1
- Hypersensitivity to an SGLT2 inhibitor
- History of drug or alcohol abuse within the last 12 months
Data sourced from ClinicalTrials.gov (NCT00962065). 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.