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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742208
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 26, 2017
Lexicon Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: LX4211 Drug: LX4211 Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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

Experimental: Pioneer Drug: LX4211
Subjects will receive LX4211 once daily for 29 days; pioneer subjects will complete dosing prior to dosing any other study subjects.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assess total exogenous daily bolus and basal insulin use [ Time Frame: Daily, Baseline through Day 28 ]
  2. Assess the amount of exogenous use at each meal [ Time Frame: Daily, Baseline through Day 28 ]
  3. Change from baseline in fasting plasma glucose [ Time Frame: Days -1, 1-3, 8, 13, 28-31 and 37 ]
  4. Change in glucose levels as measured by Continuous Glucose Monitoring (CGM) [ Time Frame: Week 1 through week 5 ]
  5. 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 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742208

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
Study Director: Paul Strumph, M.D. Lexicon Pharmaceuticals, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT01742208     History of Changes
Other Study ID Numbers: LX4211.1-203-T1DM
LX4211.203 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

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