Phase 2
Completed N=299
Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
Source: ClinicalTrials.gov NCT01376557 ↗Enrolled (actual)
299
Serious AEs
1.4%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline in HbA1c to Week 12 — -0.42; -0.52; -0.92; -0.80 % change
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c to Week 12 |
-0.42; -0.52; -0.92; -0.80; -0.09 | — |
| SECONDARY Number of Participants Achieving a HbA1c Value of <7% at Week 12 |
16; 15; 22; 17; 14 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 |
-9.5; -17.4; -27.1; -26.9; 2.2 | — |
| SECONDARY Change From Baseline in Body Weight at Week 12 |
-0.995; -1.956; -1.848; -2.477; -0.395 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SPB) at Week 12 |
-0.123; -3.878; -5.746; -4.452; -0.283 | — |
| SECONDARY Change From Baseline in Triglycerides at Week 12 |
-16.2; 6.6; -16.8; -16.9; -30.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01376557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.