Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00962065

Enrollment

Registered

2009-08-19

Start date

2009-08-31

Completion date

Unknown

Last updated

2011-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

DRUGLX4211 Low Dose

A low dose of LX4211; daily oral intake for 28 days

DRUGLX4211 High Dose

A high dose of LX4211; daily oral intake for 28 days

DRUGPlacebo

Matching placebo dosing with daily oral intake for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion	Baseline to Day 28	To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.

Secondary

Measure	Time frame
Change From Baseline at Day 29 in Fasting Plasma Glucose	Baseline to Day 29
Change From Baseline at Day 28 in Plasma HbA1c	Baseline to Day 28
Change From Baseline at Day 28 in Plasma Fructosamine Level	Baseline to Day 28
Change From Baseline at Day 28 in Mean Arterial Pressure	Baseline to Day 28
Change From Baseline at Day 28 in Triglycerides	Baseline to Day 28

Countries

United States

Participant flow

Recruitment details

This was a single-center trial in the United States, with 1 investigator participating.

Pre-assignment details

There was a 14-day washout period and a 5-day diet stabilization period prior to randomization.

Participants by arm

Arm	Count
Low Dose A low dose of LX4211; daily oral intake for 28 days	12
High Dose A high dose of LX4211; daily oral intake for 28 days	12
Placebo Matching placebo dosing with daily oral intake for 28 days	12
Total	36

Baseline characteristics

Characteristic	Low Dose	High Dose	Placebo	Total
Age Continuous	52.7 years STANDARD_DEVIATION 6.07	52.3 years STANDARD_DEVIATION 8.4	54.5 years STANDARD_DEVIATION 7.23	53.2 years STANDARD_DEVIATION 7.15
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants	10 Participants	11 Participants	29 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants	2 Participants	1 Participants	7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants	2 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Black or African American	2 Participants	0 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized White or Caucasian	10 Participants	10 Participants	12 Participants	32 Participants
Region of Enrollment United States	12 participants	12 participants	12 participants	36 participants
Sex: Female, Male Female	6 Participants	4 Participants	6 Participants	16 Participants
Sex: Female, Male Male	6 Participants	8 Participants	6 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	9 / 12	8 / 12	8 / 12
serious Total, serious adverse events	0 / 12	0 / 12	0 / 12

Outcome results

Primary

Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion

To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.