Clinical trial NCT00962065: Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
Official title: A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX4211 in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-08-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Change From Baseline at Day 29 in Fasting Plasma Glucose
timeFrame: Baseline to Day 29
measure: Change From Baseline at Day 28 in Plasma HbA1c
timeFrame: Baseline to Day 28
measure: Change From Baseline at Day 28 in Plasma Fructosamine Level
timeFrame: Baseline to Day 28
measure: Change From Baseline at Day 28 in Mean Arterial Pressure
timeFrame: Baseline to Day 28
measure: Change From Baseline at Day 28 in Triglycerides
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Joel P. Freiman, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Zambrowicz B, Freiman J, Brown PM, Frazier KS, Turnage A, Bronner J, Ruff D, Shadoan M, Banks P, Mseeh F, Rawlins DB, Goodwin NC, Mabon R, Harrison BA, Wilson A, Sands A, Powell DR. LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2012 Aug;92(2):158-69. doi: 10.1038/clpt.2012.58. Epub 2012 Jul 4.