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Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment

Primary Purpose

Type 2 Diabetes Mellitus, Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LX4211

LX4211 Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults ≥18 to ≤80 years of age
History of T2DM for at least 6 months prior to screening
Moderate to severe renal impairment and not actively on dialysis
Willing and able to perform self-monitoring of blood glucose
Willing and able to provide written informed consent

Exclusion Criteria:

History of type 1 diabetes mellitus, diabetic ketoacidosis (within the previous 6 months), or diabetes resulting from pancreatic disorder or secondary diabetes (from acromegaly and/or Cushing's disease)
Subjects who have received a renal allograft
Subjects expecting to require dialysis or to undergo kidney transplantation within 3 months of study dosing
Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or planned study Day -1
Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day -2
History of clinically significant cardiac arrhythmias within 1 year prior to study Day -2
Subjects with congestive heart failure
Subjects with uncontrolled Stage III hypertension
History of 2 or more emergency room visits, doctors' visits, or hospitalizations due to hypoglycemia within the 6 months prior to planned study Day -2
History of alcohol or illicit drug abuse within 1 year prior to Screening
History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Major surgery within 6 months prior to planned study Day -2
History of any malignancy within the last 5 years
Triglycerides >1000 mg/dL at Screening or planned study Day -1
History of any serious adverse reaction or hypersensitivity to an SGLT inhibitor
Use of corticosteroids within 2 weeks prior to study Day 1
Use of any investigational drug within 30 days prior to study Day 1, or investigational protein or antibodies within 60 days of Day 1
Positive urine pregnancy test at Screening
Positive urine screen for illicit drug abuse at Screening
Prior exposure to LX4211

Sites / Locations

Lexicon Investigational Site
Lexicon Investigational Site
Lexicon Investigational Site
Lexicon Investigational Site
Lexicon Investigational Site
Lexicon Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment A

LX4211 Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in postprandial glucose

Secondary Outcome Measures

Number of subjects experiencing an adverse event

Change from baseline in fasting plasma glucose

Change from baseline in glucagon-like peptide 1 (Glp-1)

Area Under Curve (AUC)

Full Information

NCT ID

NCT01555008

First Posted

March 7, 2012

Last Updated

September 6, 2013

Sponsor

Lexicon Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01555008

Brief Title

Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment

Official Title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes Mellitus and Moderate to Severe Renal Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lexicon Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Renal Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Experimental

Arm Title

LX4211 Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LX4211

Intervention Description

Subjects will receive LX4211 once daily for 7 days

Intervention Type

Drug

Intervention Name(s)

LX4211 Placebo

Intervention Description

Subjects will receive LX4211 placebo once daily for 7 days

Primary Outcome Measure Information:

Title

Change from baseline in postprandial glucose

Time Frame

baseline to 7 days

Secondary Outcome Measure Information:

Title

Number of subjects experiencing an adverse event

Time Frame

7 days

Title

Change from baseline in fasting plasma glucose

Time Frame

baseline to 7 days

Title

Change from baseline in glucagon-like peptide 1 (Glp-1)

Time Frame

baseline to 7 days

Title

Area Under Curve (AUC)

Time Frame

Days 1 and 7; predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults ≥18 to ≤80 years of age History of T2DM for at least 6 months prior to screening Moderate to severe renal impairment and not actively on dialysis Willing and able to perform self-monitoring of blood glucose Willing and able to provide written informed consent Exclusion Criteria: History of type 1 diabetes mellitus, diabetic ketoacidosis (within the previous 6 months), or diabetes resulting from pancreatic disorder or secondary diabetes (from acromegaly and/or Cushing's disease) Subjects who have received a renal allograft Subjects expecting to require dialysis or to undergo kidney transplantation within 3 months of study dosing Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or planned study Day -1 Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day -2 History of clinically significant cardiac arrhythmias within 1 year prior to study Day -2 Subjects with congestive heart failure Subjects with uncontrolled Stage III hypertension History of 2 or more emergency room visits, doctors' visits, or hospitalizations due to hypoglycemia within the 6 months prior to planned study Day -2 History of alcohol or illicit drug abuse within 1 year prior to Screening History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Major surgery within 6 months prior to planned study Day -2 History of any malignancy within the last 5 years Triglycerides >1000 mg/dL at Screening or planned study Day -1 History of any serious adverse reaction or hypersensitivity to an SGLT inhibitor Use of corticosteroids within 2 weeks prior to study Day 1 Use of any investigational drug within 30 days prior to study Day 1, or investigational protein or antibodies within 60 days of Day 1 Positive urine pregnancy test at Screening Positive urine screen for illicit drug abuse at Screening Prior exposure to LX4211

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ike Ogbaa, M.D.

Organizational Affiliation

Lexicon Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Lexicon Investigational Site

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Lexicon Investigational Site

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

Lexicon Investigational Site

City

Edgewater

State/Province

Florida

ZIP/Postal Code

32132

Country

United States

Facility Name

Lexicon Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Lexicon Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

Facility Name

Lexicon Investigational Site

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25529979

Citation

Zambrowicz B, Lapuerta P, Strumph P, Banks P, Wilson A, Ogbaa I, Sands A, Powell D. LX4211 therapy reduces postprandial glucose levels in patients with type 2 diabetes mellitus and renal impairment despite low urinary glucose excretion. Clin Ther. 2015 Jan 1;37(1):71-82.e12. doi: 10.1016/j.clinthera.2014.10.026. Epub 2014 Dec 17.

Results Reference

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Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment

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