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Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01188863
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : March 30, 2011
Sponsor:
Information provided by:
Lexicon Pharmaceuticals

Brief Summary:
This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: 300 mg LX4211 (150 mg tablets) Drug: 300 mg LX4211 (50 mg tablets) Drug: 300 mg LX4211 (liquid) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Open-Label, Three-Way Crossover Study of Two Oral Formulations of LX4211 in Subjects With Type 2 Diabetes Mellitus
Study Start Date : September 2010
Actual Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Solid Oral Dose - 150 mg tablets Drug: 300 mg LX4211 (150 mg tablets)
Single oral dose of two 150 mg tablets LX4211

Experimental: Solid Oral Dose - 50 mg tablets Drug: 300 mg LX4211 (50 mg tablets)
Single oral dose of six 50 mg tablets LX4211

Experimental: Liquid Oral Dose Drug: 300 mg LX4211 (liquid)
Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)




Primary Outcome Measures :
  1. Maximum observed plasma concentration [ Time Frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up). ]
  2. Time at which maximum observed plasma concentration occurs [ Time Frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up). ]
  3. Half-life of the drug in plasma [ Time Frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up). ]

Secondary Outcome Measures :
  1. Plasma glucose [ Time Frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge. ]
  2. Urinary glucose excretion [ Time Frame: Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up). ]
  3. Insulin [ Time Frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge. ]
  4. Peptide YY [ Time Frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge. ]
  5. Glucagon-like Peptide 1 [ Time Frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18 to 65 years of age
  • Males and females of non-childbearing potential
  • Diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
  • Fasting plasma glucose ≤240 mg/dL
  • Body mass index <42 kg/sq m
  • HbA1c of 7-11%
  • C-peptide of ≥1.0 ng/mL
  • Ability to provide written informed consent

Exclusion Criteria:

  • History of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia
  • Current use of any blood glucose-lowering agent other than metformin
  • Exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
  • History of HIV, Hepatitis B, or Hepatitis C
  • Surgery within 6 months of screening
  • Donation or loss of >400 mL of blood or blood product within 8 weeks prior to start of study
  • Use of proteins or antibodies within 12 weeks prior to screening. (Flu shots are allowed.)
  • Exposure to any investigational agent or participation in an investigational trial within 30 days of the start of the study
  • History of drug or alcohol abuse within 12 months prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188863


Locations
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United States, Texas
Lexicon Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Joel P. Freiman, MD, MPH Lexicon Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joel P. Freiman, MD, MPH, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01188863    
Other Study ID Numbers: LX4211.1-102-DM
LX4211.102 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: March 30, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs