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Completed

NCT Number: NCT01188863

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

300 mg LX4211 (150 mg tablets)

Drug

Single oral dose of two 150 mg tablets LX4211

300 mg LX4211 (50 mg tablets)

Drug

Single oral dose of six 50 mg tablets LX4211

300 mg LX4211 (liquid)

Drug

Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-Label, Three-Way Crossover Study of Two Oral Formulations of LX4211 in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2010
Primary completion
2010
First posted
Aug 26, 2010
Registry last updated
Mar 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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