Trial Outcomes & Findings for Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy (NCT NCT01811485)
NCT ID: NCT01811485
Last Updated: 2015-02-23
Results Overview
HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
171 participants
Primary outcome timeframe
Baseline to 14 weeks
Results posted on
2015-02-23
Participant Flow
Participant milestones
| Measure |
LMF237 50/250 mg
Patients took LMF237 50/250 mg twice daily for 14 weeks
|
LMF237 50/500 mg
Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
|
Placebo
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
59
|
56
|
|
Overall Study
COMPLETED
|
54
|
55
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
5
|
Reasons for withdrawal
| Measure |
LMF237 50/250 mg
Patients took LMF237 50/250 mg twice daily for 14 weeks
|
LMF237 50/500 mg
Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
|
Placebo
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
2
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
0
|
3
|
|
Overall Study
Administrative problems
|
1
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
0
|
Baseline Characteristics
Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy
Baseline characteristics by cohort
| Measure |
LMF237 50/250 mg
n=56 Participants
Patients took LMF237 50/250 mg twice daily for 14 weeks
|
LMF237 50/500 mg
n=59 Participants
Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
|
Placebo
n=56 Participants
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 10.50 • n=7 Participants
|
56.2 Years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
57.0 Years
STANDARD_DEVIATION 10.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 14 weeksPopulation: Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.
HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.
Outcome measures
| Measure |
Pooled LMF237
n=115 Participants
All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
|
Placebo
n=56 Participants
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
Placebo
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups
|
-0.83 percentage of glycosylated haemoglobin
Standard Error 0.06
|
0.14 percentage of glycosylated haemoglobin
Standard Error 0.08
|
—
|
SECONDARY outcome
Timeframe: Baseline to 14 weeksPopulation: Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.
HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory.
Outcome measures
| Measure |
Pooled LMF237
n=56 Participants
All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
|
Placebo
n=59 Participants
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
Placebo
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|
|
Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups
|
-0.61 percentage of glycosylated haemoglobin
Standard Error 0.06
|
-1.04 percentage of glycosylated haemoglobin
Standard Error 0.06
|
—
|
SECONDARY outcome
Timeframe: Baseline, 14 weeksPopulation: The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.
Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c \< 7% 3. Endpoint HbA1c \< 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c \< 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%. Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c \> 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements.
Outcome measures
| Measure |
Pooled LMF237
n=115 Participants
All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
|
Placebo
n=56 Participants
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
Placebo
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|
|
Percentage of Patients Meeting Responder Rates in HbA1c
HbA1c ≤ 6.5% (n=115, 56)
|
27.8 Percentage of patients
|
0.0 Percentage of patients
|
—
|
|
Percentage of Patients Meeting Responder Rates in HbA1c
HbA1c < 7.0% (n= 107, 52)
|
45.8 Percentage of patients
|
13.5 Percentage of patients
|
—
|
|
Percentage of Patients Meeting Responder Rates in HbA1c
HbA1c < 7.0% with baseline HbA1c ≤ 8.0% (n=69,33)
|
66.7 Percentage of patients
|
18.2 Percentage of patients
|
—
|
|
Percentage of Patients Meeting Responder Rates in HbA1c
HbA1c < 6.9% (n= 111, 54)
|
45.0 Percentage of patients
|
9.3 Percentage of patients
|
—
|
|
Percentage of Patients Meeting Responder Rates in HbA1c
Reduction of HbA1c ≥ 1% (n= 115, 56)
|
36.5 Percentage of patients
|
1.8 Percentage of patients
|
—
|
|
Percentage of Patients Meeting Responder Rates in HbA1c
Reduction of HbA1c ≥ 0.5% (n= 115, 56)
|
73.9 Percentage of patients
|
16.1 Percentage of patients
|
—
|
SECONDARY outcome
Timeframe: Baseline to 14 weeksPopulation: FAS consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.
FPG was performed on a blood sample obtained and analyzed at a central laboratory.
Outcome measures
| Measure |
Pooled LMF237
n=115 Participants
All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
|
Placebo
n=56 Participants
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
Placebo
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks
|
-13.02 mg/dL
Standard Error 2.83
|
16.54 mg/dL
Standard Error 4.06
|
—
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Safety set (SAF): consists of all patients who received at least one dose of study medication.
The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Outcome measures
| Measure |
Pooled LMF237
n=56 Participants
All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
|
Placebo
n=59 Participants
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
Placebo
n=56 Participants
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|
|
Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death
Any AE (Serious and non-serious)
|
25 Patients
|
25 Patients
|
38 Patients
|
|
Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death
Serious AEs
|
0 Patients
|
1 Patients
|
2 Patients
|
|
Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death
Death
|
0 Patients
|
0 Patients
|
0 Patients
|
Adverse Events
POOLED LMF237
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
LMF237 50/250mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
LMF237 50/500mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
POOLED LMF237
n=115 participants at risk
All patients who has received LMF237
|
LMF237 50/250mg
n=56 participants at risk
Patients took LMF237 50/250 mg twice daily for 14 weeks
|
LMF237 50/500mg
n=59 participants at risk
Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
|
Placebo
n=56 participants at risk
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Epiglottitis
|
0.00%
0/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
1.8%
1/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
1.8%
1/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.87%
1/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
1.7%
1/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.87%
1/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
1.7%
1/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
Other adverse events
| Measure |
POOLED LMF237
n=115 participants at risk
All patients who has received LMF237
|
LMF237 50/250mg
n=56 participants at risk
Patients took LMF237 50/250 mg twice daily for 14 weeks
|
LMF237 50/500mg
n=59 participants at risk
Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
|
Placebo
n=56 participants at risk
Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.6%
3/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
5.1%
3/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
2/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
3.6%
2/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
5.4%
3/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
6/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
1.8%
1/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
8.5%
5/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
3.6%
2/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
2.6%
3/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
5.1%
3/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
1.8%
1/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
9.6%
11/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
7.1%
4/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
11.9%
7/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
17.9%
10/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Investigations
Lipase increased
|
0.00%
0/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
5.4%
3/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
2.6%
3/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
5.1%
3/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
|
Nervous system disorders
Tremor
|
2.6%
3/115
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
5.1%
3/59
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
0.00%
0/56
Safety set (SAF): The SAF consists of all patients who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER