Safety and Efficacy of LX4211 in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01742208
First received: November 20, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

This Phase 2 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of LX4211 following daily oral administration for 29 days in patients with type 1 diabetes mellitus (T1DM).


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: LX4211
Drug: LX4211 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, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of LX4211 in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • To assess the effect of LX4211 on the total daily bolus amount of exogenous insulin required to maintain or improve glycemic control [ Time Frame: Daily, Baseline through Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess total exogenous daily bolus and basal insulin use [ Time Frame: Daily, Baseline through Day 28 ] [ Designated as safety issue: No ]
  • Assess the amount of exogenous use at each meal [ Time Frame: Daily, Baseline through Day 28 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: Days -1, 1-3, 8, 13, 28-31 and 37 ] [ Designated as safety issue: No ]
  • Change in glucose levels as measured by Continuous Glucose Monitoring (CGM) [ Time Frame: Week 1 through week 5 ] [ Designated as safety issue: No ]
  • Change in postprandial glucose by Area Under Curve (AUC) [ Time Frame: Day 1 and Day 29; predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: February 2013
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: LX4211
Subjects will receive LX4211 once daily for 29 days
Placebo Comparator: LX4211 Placebo Drug: LX4211 Placebo
Subjects will receive LX4211 placebo once daily for 29 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥18 to ≤55 years of age
  • Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6 months prior to Screening
  • Willing to refrain from using carbohydrate counting to adjust insulin during the study
  • Willing and able to wear and operate a continuous glucose monitor
  • Willing and able to self-assess blood-glucose
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushing's disease, chronic pancreatitis, or pancreatectomy
  • Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening
  • Use of premixed insulin
  • History of diabetic ketoacidosis within 1 year of screening
  • Presence of active hepatic disease or clinically significant abnormal liver function tests
  • History of chronic pancreatitis
  • Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure
  • History of clinically significant cardiac arrhythmias within 1 year prior to screening
  • Subjects with congestive heart failure
  • Subjects with uncontrolled Stage III hypertension
  • History of human immunodeficiency virus (HIV) or hepatitis C
  • History of illicit drug or alcohol abuse within 12 months prior to Screening
  • Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening
  • Use of medication or herbal supplements taken for weight loss within 2 weeks of screening
  • Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening
  • Use of systemic or inhaled corticosteroids within 2 weeks prior to Screening
  • Subjects who have undergone major surgery within 6 months prior to Screening
  • Inability or difficulty swallowing whole tablets or capsules
  • Women who are pregnant or breastfeeding
  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: NCT01742208

Locations
United States, Colorado
Lexicon Investigational Site
Aurora, Colorado, United States, 80045
United States, Georgia
Lexicon Investigational Site
Atlanta, Georgia, United States, 30318
United States, Louisiana
Lexicon Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Nebraska
Lexicon Investigational Site
Omaha, Nebraska, United States, 68131
United States, New York
Lexicon Investigational Site
Bronx, New York, United States, 10467
United States, North Carolina
Lexicon Investigational Site
Durham, North Carolina, United States, 27713
United States, Texas
Lexicon Investigational Site
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Paul Strumph, M.D. Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01742208     History of Changes
Other Study ID Numbers: LX4211.1-203-T1DM, LX4211.203
Study First Received: November 20, 2012
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014