Trial Outcomes & Findings for Study of LX4211 in Subjects With Type 2 Diabetes Mellitus (NCT NCT00962065)

NCT ID: NCT00962065

Last Updated: 2011-03-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: Baseline to Day 28
• Results posted on: 2011-03-03

Participant Flow

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

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

Participant milestones

Measure	Low Dose A low dose of LX4211; daily oral intake for 28 days	High Dose A high dose of LX4211; daily oral intake for 28 days	Placebo Matching placebo dosing with daily oral intake for 28 days
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	12	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Low Dose n=12 Participants A low dose of LX4211; daily oral intake for 28 days	High Dose n=12 Participants A high dose of LX4211; daily oral intake for 28 days	Placebo n=12 Participants Matching placebo dosing with daily oral intake for 28 days	Total n=36 Participants Total of all reporting groups
Age Continuous	52.7 years STANDARD_DEVIATION 6.07 • n=5 Participants	52.3 years STANDARD_DEVIATION 8.40 • n=7 Participants	54.5 years STANDARD_DEVIATION 7.23 • n=5 Participants	53.2 years STANDARD_DEVIATION 7.15 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White or Caucasian	10 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	36 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28

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

Outcome measures

Measure	Low Dose n=12 Participants A low dose of LX4211; daily oral intake for 28 days	High Dose n=12 Participants A high dose of LX4211; daily oral intake for 28 days	Placebo n=12 Participants Matching placebo dosing with daily oral intake for 28 days
Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion	35.729 grams Interval 26.207 to 45.252	47.085 grams Interval 37.562 to 56.608	-0.965 grams Interval -10.768 to 8.838

SECONDARY outcome

Timeframe: Baseline to Day 29

Outcome measures

Measure	Low Dose n=12 Participants A low dose of LX4211; daily oral intake for 28 days	High Dose n=12 Participants A high dose of LX4211; daily oral intake for 28 days	Placebo n=12 Participants Matching placebo dosing with daily oral intake for 28 days
Change From Baseline at Day 29 in Fasting Plasma Glucose	-52.3 mg/dL Interval -67.7 to -36.9	-67.8 mg/dL Interval -83.2 to -52.4	-12.3 mg/dL Interval -28.0 to 3.4

SECONDARY outcome

Timeframe: Baseline to Day 28

Outcome measures

Measure	Low Dose n=12 Participants A low dose of LX4211; daily oral intake for 28 days	High Dose n=12 Participants A high dose of LX4211; daily oral intake for 28 days	Placebo n=12 Participants Matching placebo dosing with daily oral intake for 28 days
Change From Baseline at Day 28 in Plasma HbA1c	-1.15 Percent Interval -1.58 to -0.72	-1.25 Percent Interval -1.68 to -0.82	-0.49 Percent Interval -0.93 to -0.05

SECONDARY outcome

Timeframe: Baseline to Day 28

Outcome measures

Measure	Low Dose n=12 Participants A low dose of LX4211; daily oral intake for 28 days	High Dose n=12 Participants A high dose of LX4211; daily oral intake for 28 days	Placebo n=12 Participants Matching placebo dosing with daily oral intake for 28 days
Change From Baseline at Day 28 in Plasma Fructosamine Level	-24.5 µmol/L Interval -39.5 to -9.5	-24.9 µmol/L Interval -39.9 to -9.9	18.1 µmol/L Interval 2.7 to 33.5

SECONDARY outcome

Timeframe: Baseline to Day 28

Outcome measures

Measure	Low Dose n=12 Participants A low dose of LX4211; daily oral intake for 28 days	High Dose n=12 Participants A high dose of LX4211; daily oral intake for 28 days	Placebo n=12 Participants Matching placebo dosing with daily oral intake for 28 days
Change From Baseline at Day 28 in Mean Arterial Pressure Standing	-8.6 mm Hg Interval -13.8 to -3.4	-5.6 mm Hg Interval -10.8 to -0.4	-3.8 mm Hg Interval -9.2 to 1.6
Change From Baseline at Day 28 in Mean Arterial Pressure Seated	-7.3 mm Hg Interval -12.3 to -2.4	-7.9 mm Hg Interval -12.9 to -3.0	-3.4 mm Hg Interval -8.5 to 1.8
Change From Baseline at Day 28 in Mean Arterial Pressure Supine	-8.2 mm Hg Interval -13.2 to -3.3	-6.1 mm Hg Interval -11.0 to -1.2	-4.9 mm Hg Interval -10.1 to 0.2

SECONDARY outcome

Timeframe: Baseline to Day 28

Outcome measures

Measure	Low Dose n=12 Participants A low dose of LX4211; daily oral intake for 28 days	High Dose n=12 Participants A high dose of LX4211; daily oral intake for 28 days	Placebo n=12 Participants Matching placebo dosing with daily oral intake for 28 days
Change From Baseline at Day 28 in Triglycerides	-66.6 mg/dL Interval -105.2 to -28.0	-62.8 mg/dL Interval -101.3 to -24.2	-20.2 mg/dL Interval -60.5 to 20.1

Adverse Events

Low Dose

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

High Dose

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Dose n=12 participants at risk A low dose of LX4211; daily oral intake for 28 days	High Dose n=12 participants at risk A high dose of LX4211; daily oral intake for 28 days	Placebo n=12 participants at risk Matching placebo dosing with daily oral intake for 28 days
Nervous system disorders Headache	41.7% 5/12 • Number of events 10 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 15 • Adverse events were followed during the treatment period.	16.7% 2/12 • Number of events 3 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Constipation	25.0% 3/12 • Number of events 3 • Adverse events were followed during the treatment period.	16.7% 2/12 • Number of events 2 • Adverse events were followed during the treatment period.	16.7% 2/12 • Number of events 2 • Adverse events were followed during the treatment period.
Nervous system disorders Dizziness	25.0% 3/12 • Number of events 3 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	16.7% 2/12 • Number of events 2 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Nausea	16.7% 2/12 • Number of events 4 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 14 • Adverse events were followed during the treatment period.	16.7% 2/12 • Number of events 2 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Abdominal Pain	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	16.7% 2/12 • Number of events 3 • Adverse events were followed during the treatment period.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Diarrhea	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Flatulence	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Metabolism and nutrition disorders Hyponatremia	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Renal and urinary disorders Pyuria	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Number of events 2 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Infections and infestations Upper Respiratory Tract Infection	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 2 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Abdominal Distension	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Abdominal Pain Lower	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Blood and lymphatic system disorders Anemia	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Psychiatric disorders Anxiety	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
General disorders Asthenia	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Renal and urinary disorders Bacteriuria	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Skin and subcutaneous tissue disorders Blister	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Eye disorders Conjunctivitis	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Infections and infestations Cystitis	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Renal and urinary disorders Dysuria	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Ear and labyrinth disorders Ear Pain	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Skin and subcutaneous tissue disorders Erythema	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
General disorders Fatigue	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Renal and urinary disorders Hematuria	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Metabolism and nutrition disorders Hyperglycemia	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Vascular disorders Hypertension	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Psychiatric disorders Mood altered	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Psychiatric disorders Mood swings	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Renal and urinary disorders Polyuria	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Injury, poisoning and procedural complications Post procedural discomfort	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Reproductive system and breast disorders Pruritis genital	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Psychiatric disorders Sleep disorder	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
General disorders Suprapubic pain	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Infections and infestations Trichomoniasis	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.
Investigations Weight decreased	0.00% 0/12 • Adverse events were followed during the treatment period.	0.00% 0/12 • Adverse events were followed during the treatment period.	8.3% 1/12 • Number of events 1 • Adverse events were followed during the treatment period.

Additional Information

Joel P. Freiman, MD, MPH

Lexicon Pharmaceuticals, Inc.

Phone: 281-863-3000

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor requires that written permission be given before the PI can release any data publicly.
• Publication restrictions are in place

Restriction type: OTHER