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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 19, 2014