Trial Outcomes & Findings for Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin (NCT NCT01376557)
NCT ID: NCT01376557
Last Updated: 2014-10-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
299 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-10-31
Participant Flow
Participant milestones
| Measure |
75 mg LX4211 qd
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
51
|
54
|
55
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
5
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
Baseline characteristics by cohort
| Measure |
75 mg LX4211 qd
n=59 Participants
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=60 Participants
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=60 Participants
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=60 Participants
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=60 Participants
Placebo: Subjects will receive placebo once daily.
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 9.25 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 8.76 • n=4 Participants
|
55.1 years
STANDARD_DEVIATION 9.79 • n=21 Participants
|
55.9 years
STANDARD_DEVIATION 9.34 • n=8 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
164 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
135 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
252 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
82 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
217 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
60 participants
n=7 Participants
|
60 participants
n=5 Participants
|
60 participants
n=4 Participants
|
60 participants
n=21 Participants
|
299 participants
n=8 Participants
|
|
Height
|
169.25 cm
STANDARD_DEVIATION 10.419 • n=5 Participants
|
166.99 cm
STANDARD_DEVIATION 10.764 • n=7 Participants
|
167.04 cm
STANDARD_DEVIATION 9.849 • n=5 Participants
|
169.39 cm
STANDARD_DEVIATION 11.171 • n=4 Participants
|
167.18 cm
STANDARD_DEVIATION 10.240 • n=21 Participants
|
167.96 cm
STANDARD_DEVIATION 10.486 • n=8 Participants
|
|
Weight
|
96.16 kg
STANDARD_DEVIATION 19.328 • n=5 Participants
|
95.59 kg
STANDARD_DEVIATION 19.368 • n=7 Participants
|
91.38 kg
STANDARD_DEVIATION 18.643 • n=5 Participants
|
95.01 kg
STANDARD_DEVIATION 22.202 • n=4 Participants
|
90.57 kg
STANDARD_DEVIATION 20.726 • n=21 Participants
|
93.73 kg
STANDARD_DEVIATION 20.093 • n=8 Participants
|
|
Body Mass index (BMI)
|
33.44 kg/m^2
STANDARD_DEVIATION 5.237 • n=5 Participants
|
34.23 kg/m^2
STANDARD_DEVIATION 5.816 • n=7 Participants
|
32.69 kg/m^2
STANDARD_DEVIATION 5.757 • n=5 Participants
|
32.85 kg/m^2
STANDARD_DEVIATION 5.626 • n=4 Participants
|
32.17 kg/m^2
STANDARD_DEVIATION 5.796 • n=21 Participants
|
33.08 kg/m^2
STANDARD_DEVIATION 5.658 • n=8 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
75 mg LX4211 qd
n=56 Participants
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=58 Participants
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=57 Participants
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=57 Participants
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=57 Participants
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in HbA1c to Week 12
|
-0.42 % change
Standard Deviation 0.637
|
-0.52 % change
Standard Deviation 0.780
|
-0.92 % change
Standard Deviation 0.873
|
-0.80 % change
Standard Deviation 0.932
|
-0.09 % change
Standard Deviation 0.770
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
75 mg LX4211 qd
n=56 Participants
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=58 Participants
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=57 Participants
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=57 Participants
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=57 Participants
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Number of Participants Achieving a HbA1c Value of <7% at Week 12
|
16 participants
|
15 participants
|
22 participants
|
17 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
75 mg LX4211 qd
n=56 Participants
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=60 Participants
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=59 Participants
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=58 Participants
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=60 Participants
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12
|
-9.5 mg/dL
Standard Deviation 27.35
|
-17.4 mg/dL
Standard Deviation 40.45
|
-27.1 mg/dL
Standard Deviation 38.48
|
-26.9 mg/dL
Standard Deviation 35.07
|
2.2 mg/dL
Standard Deviation 45.35
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
75 mg LX4211 qd
n=57 Participants
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=60 Participants
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=59 Participants
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=59 Participants
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=60 Participants
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 12
|
-0.995 kg
Standard Deviation 3.1130
|
-1.956 kg
Standard Deviation 2.5360
|
-1.848 kg
Standard Deviation 1.9641
|
-2.477 kg
Standard Deviation 2.5610
|
-0.395 kg
Standard Deviation 1.9813
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
75 mg LX4211 qd
n=57 Participants
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=60 Participants
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=59 Participants
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=59 Participants
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=60 Participants
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SPB) at Week 12
|
-0.123 mm Hg
Standard Deviation 12.6921
|
-3.878 mm Hg
Standard Deviation 12.1935
|
-5.746 mm Hg
Standard Deviation 12.3675
|
-4.452 mm Hg
Standard Deviation 12.1401
|
-0.283 mm Hg
Standard Deviation 13.5945
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT
Outcome measures
| Measure |
75 mg LX4211 qd
n=56 Participants
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=58 Participants
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=57 Participants
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=57 Participants
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=58 Participants
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Change From Baseline in Triglycerides at Week 12
|
-16.2 mg/dL
Standard Deviation 84.17
|
6.6 mg/dL
Standard Deviation 77.05
|
-16.8 mg/dL
Standard Deviation 121.90
|
-16.9 mg/dL
Standard Deviation 73.13
|
-30.5 mg/dL
Standard Deviation 201.92
|
Adverse Events
75 mg LX4211 qd
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
200 mg LX4211 qd
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
400 mg LX4211 qd
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
200 mg LX4211 Bid
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo qd
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
75 mg LX4211 qd
n=57 participants at risk
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=60 participants at risk
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=59 participants at risk
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=60 participants at risk
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=60 participants at risk
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
bile duct stone
|
0.00%
0/57
Safety population
|
1.7%
1/60
Safety population
|
0.00%
0/59
Safety population
|
0.00%
0/60
Safety population
|
0.00%
0/60
Safety population
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/57
Safety population
|
0.00%
0/60
Safety population
|
1.7%
1/59
Safety population
|
0.00%
0/60
Safety population
|
0.00%
0/60
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/57
Safety population
|
0.00%
0/60
Safety population
|
1.7%
1/59
Safety population
|
0.00%
0/60
Safety population
|
0.00%
0/60
Safety population
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/57
Safety population
|
0.00%
0/60
Safety population
|
1.7%
1/59
Safety population
|
0.00%
0/60
Safety population
|
0.00%
0/60
Safety population
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/57
Safety population
|
0.00%
0/60
Safety population
|
0.00%
0/59
Safety population
|
0.00%
0/60
Safety population
|
1.7%
1/60
Safety population
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/57
Safety population
|
1.7%
1/60
Safety population
|
0.00%
0/59
Safety population
|
0.00%
0/60
Safety population
|
0.00%
0/60
Safety population
|
Other adverse events
| Measure |
75 mg LX4211 qd
n=57 participants at risk
Subjects will receive 75 mg LX4211 once daily
|
200 mg LX4211 qd
n=60 participants at risk
Subjects will receive 200 mg LX4211 once daily.
|
400 mg LX4211 qd
n=59 participants at risk
Subjects will receive 400 mg LX4211 once daily.
|
200 mg LX4211 Bid
n=60 participants at risk
Subjects will receive 200 mg LX4211 twice daily.
|
Placebo qd
n=60 participants at risk
Placebo: Subjects will receive placebo once daily.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
2/57
Safety population
|
10.0%
6/60
Safety population
|
8.5%
5/59
Safety population
|
6.7%
4/60
Safety population
|
6.7%
4/60
Safety population
|
|
Gastrointestinal disorders
Nausea
|
8.8%
5/57
Safety population
|
5.0%
3/60
Safety population
|
10.2%
6/59
Safety population
|
3.3%
2/60
Safety population
|
5.0%
3/60
Safety population
|
|
Nervous system disorders
Headache
|
10.5%
6/57
Safety population
|
10.0%
6/60
Safety population
|
5.1%
3/59
Safety population
|
3.3%
2/60
Safety population
|
1.7%
1/60
Safety population
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/57
Safety population
|
8.3%
5/60
Safety population
|
1.7%
1/59
Safety population
|
1.7%
1/60
Safety population
|
6.7%
4/60
Safety population
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
2/57
Safety population
|
3.3%
2/60
Safety population
|
1.7%
1/59
Safety population
|
5.0%
3/60
Safety population
|
5.0%
3/60
Safety population
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
4/57
Safety population
|
3.3%
2/60
Safety population
|
3.4%
2/59
Safety population
|
1.7%
1/60
Safety population
|
1.7%
1/60
Safety population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.8%
1/57
Safety population
|
3.3%
2/60
Safety population
|
1.7%
1/59
Safety population
|
1.7%
1/60
Safety population
|
6.7%
4/60
Safety population
|
|
Infections and infestations
Sinusitis
|
5.3%
3/57
Safety population
|
5.0%
3/60
Safety population
|
1.7%
1/59
Safety population
|
0.00%
0/60
Safety population
|
1.7%
1/60
Safety population
|
|
Vascular disorders
Hypertension
|
3.5%
2/57
Safety population
|
0.00%
0/60
Safety population
|
1.7%
1/59
Safety population
|
5.0%
3/60
Safety population
|
3.3%
2/60
Safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
2/57
Safety population
|
0.00%
0/60
Safety population
|
5.1%
3/59
Safety population
|
1.7%
1/60
Safety population
|
3.3%
2/60
Safety population
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/57
Safety population
|
1.7%
1/60
Safety population
|
1.7%
1/59
Safety population
|
5.0%
3/60
Safety population
|
3.3%
2/60
Safety population
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
3/57
Safety population
|
1.7%
1/60
Safety population
|
1.7%
1/59
Safety population
|
3.3%
2/60
Safety population
|
0.00%
0/60
Safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/57
Safety population
|
5.0%
3/60
Safety population
|
0.00%
0/59
Safety population
|
5.0%
3/60
Safety population
|
0.00%
0/60
Safety population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/57
Safety population
|
0.00%
0/60
Safety population
|
1.7%
1/59
Safety population
|
0.00%
0/60
Safety population
|
5.0%
3/60
Safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institutions cannot publish any data generated from the clinical trial until Sponsor publishes such data or until 18 months have elapsed since completion of the clinical trial. Proposed publication must be provided to Sponsor at least 60 days prior to submission for publication and Sponsor has 30 days from receipt to review. Sponsor can delete any info to which it objects, Confidential Information, proprietary information or patentable subject matter from the final version of the publication.
- Publication restrictions are in place
Restriction type: OTHER