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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: October 29, 2014
Last verified: October 2014
  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: 75 mg LX4211
Drug: 200 mg LX4211
Drug: 400 mg 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:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline in HbA1c to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Achieving a HbA1c Value of <7% at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Weight at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Systolic Blood Pressure (SPB) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Triglycerides at Week 12 [ 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: 75 mg LX4211
Subjects will receive 75 mg LX4211 once daily
Experimental: Treatment B Drug: 200 mg LX4211
Subjects will receive 200 mg LX4211 once daily.
Experimental: Treatment C Drug: 400 mg LX4211
Subjects will receive 400 mg LX4211 once daily.
Experimental: Treatment D Drug: 200 mg LX4211
Subjects will receive 200 mg 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
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: 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
Results First Received: October 27, 2014
Last Updated: October 29, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014