A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01441232
First received: September 23, 2011
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211 when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes Mellitus.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: LX4211
Drug: Januvia®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, 3-period, 3-treatment, Single Dose Crossover Study to Evaluate the Pharmacodynamic Effects of LX4211 When Administered Concurrently With JANUVIA® (Sitagliptin) in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in gut hormones [ Time Frame: Days 1, 8, and 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: Days 1, 8, and 15 ] [ Designated as safety issue: No ]
  • Change from baseline in postprandial glucose [ Time Frame: Days 1, 8, and 15 ] [ Designated as safety issue: No ]
  • Change from baseline in insulin [ Time Frame: Days 1, 8, and 15 ] [ Designated as safety issue: No ]
  • Change from baseline in peptide YY [ Time Frame: Days 1, 8, and 15 ] [ Designated as safety issue: No ]
  • Change from baseline in urinary glucose excretion [ Time Frame: Days 1, 8, and 15 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: LX4211
400 mg of LX4211 administered as two 200 mg tablets
Experimental: Treatment C Drug: LX4211
400 mg of LX4211 administered as two 200 mg tablets
Drug: Januvia®
100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet
Active Comparator: Treatment B Drug: Januvia®
100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18 to 65 years of age
  • History of Type 2 Diabetes Mellitus for at least 3 months prior to Screening, with HgbA1c values of 6.5 to 10.5% and C-peptide ≥1.0 ng/mL
  • Body mass index (BMI) ≤45 kg/sq m
  • Willing and able to self-monitor blood glucose
  • Able to provide written informed consent

Exclusion Criteria:

  • History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
  • Current use of any blood glucose lowering agent other than metformin
  • History of renal disease or clinically significant abnormal kidney function tests at Screening or Day -2
  • Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or Day -2
  • History of myocardial infarction, severe/unstable angina, or coronary revascularization procedure within 6 months of Day -2
  • History of clinically significant cardiac arrhythmias within 1 year of Day -2
  • Congestive heart failure and/or New York Heart Association (NYHA) class III or IV symptoms of heart failure
  • Subjects with uncontrolled Stage 3 hypertension
  • History of 2 or more emergency room visits, doctor's visits, or hospitalizations due to hypoglycemia within 6 months of Day -2
  • History of alcohol or drug abuse within 12 months of Screening
  • History of bowel resection > 20 cm, any malabsorptive disorder, severe gastroparesis, and GI procedure for the purpose of weight loss that would slow gastric emptying
  • History of HIV or hepatitis C
  • Major surgery within 3 months of Day -2 or any planned surgery during the study
  • History of any active infection within 2 weeks of Day -2
  • History of pancreatitis
  • History of any malignancy within the last 5 years which would affect the diagnosis or assessment of LX4211 or sitagliptin
  • History of any serious adverse reaction or hypersensitivity to LX4211 or sitagliptin
  • Presence of any clinically significant physical, laboratory, or ECG findings or any concurrent condition at Screening that may interfere with the study in the opinion of the investigator
  • Triglycerides > 1000 mg/dL at Screening or Day -2
  • Donation or loss of >400 mL of blood or blood product within 8 weeks prior to Day -2
  • Use of any tobacco product for the duration of study participation
  • Use of corticosteroids within 2 weeks of Day 1
  • Use of digoxin or warfarin within 2 weeks prior to Screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441232

Locations
United States, Texas
Lexicon Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Ikenna Ogbaa, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided by Lexicon Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01441232     History of Changes
Other Study ID Numbers: LX4211.1-105-DM, LX4211.105
Study First Received: September 23, 2011
Last Updated: January 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014