Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
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|ClinicalTrials.gov Identifier: NCT01376557|
Recruitment Status : Completed
First Posted : June 20, 2011
Results First Posted : October 31, 2014
Last Update Posted : October 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: 75 mg LX4211 Drug: 200 mg LX4211 Drug: 400 mg LX4211 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
|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||
Subjects will receive placebo once daily.
- Change From Baseline in HbA1c to Week 12 [ Time Frame: 12 weeks ]
- Number of Participants Achieving a HbA1c Value of <7% at Week 12 [ Time Frame: 12 weeks ]
- Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 [ Time Frame: 12 weeks ]
- Change From Baseline in Body Weight at Week 12 [ Time Frame: 12 weeks ]
- Change From Baseline in Systolic Blood Pressure (SPB) at Week 12 [ Time Frame: 12 weeks ]
- Change From Baseline in Triglycerides at Week 12 [ Time Frame: 12 weeks ]
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 ClinicalTrials.gov identifier (NCT number): NCT01376557
|Study Director:||Ikenna Ogbaa, MD||Lexicon Pharmaceuticals, Inc.|