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Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01376557
First received: June 16, 2011
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Low dose LX4211
Drug: Mid dose LX4211
Drug: High dose LX4211
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of LX4211 in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving a HbA1c value of <7% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in glucose parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 299
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Low dose LX4211
Subjects will receive low dose LX4211 once daily
Experimental: Treatment B Drug: Mid dose LX4211
Subjects will receive mid dose LX4211 once daily.
Experimental: Treatment C Drug: High dose LX4211
Subjects will receive high dose LX4211 once daily.
Experimental: Treatment D Drug: Mid dose LX4211
Subjects will receive mid dose LX4211 twice daily.
Placebo Comparator: Placebo Drug: Placebo
Subjects will receive placebo once daily.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects between the ages of 18 to 75 years, inclusive
  • Confirmed diagnosis of Type 2 diabetes mellitus
  • Meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dL
  • Stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks
  • Willing and able to provide written informed consent
  • Willing and able to maintain consistent dietary, physical activity, and sleeping patterns throughout the study

Exclusion Criteria:

  • History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
  • History of renal disease or clinically significant abnormal kidney function tests
  • Presence of active hepatic disease or clinically significant abnormal liver function tests
  • Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day 1
  • History of clinically significant cardiac arrhythmias within one year of study Day 1
  • Subjects with congestive heart failure
  • Subjects with uncontrolled Stage III hypertension
  • Triglycerides >1000 mg/dL at Screening
  • Known history of HIV or hepatitis C
  • History of illicit drug or alcohol abuse with one year of study Day 1
  • Have had 2 or more emergency room visits, doctor visits, or hospitalizations due to hypoglycemia within 6 months of study Day 1
  • Use of any other investigational drug within 30 days of study Day 1
  • Prior exposure to LX4211
  • Use of any medication or herbal supplement for the purpose of weight loss
  • Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study Day 1
  • Use of corticosteroids within 2 weeks prior to study Day 1
  • Major surgery within 6 months of study Day 1
  • Subjects with any history of severe gastroparesis
  • Inability or difficulty swallowing whole capsules or tablets
  • Women who are pregnant or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376557

  Show 56 Study Locations
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Ikenna Ogbaa, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01376557     History of Changes
Other Study ID Numbers: LX4211.1-202-DM, LX4211.202
Study First Received: June 16, 2011
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Lexicon Pharmaceuticals:
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013