Trial Outcomes & Findings for Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients (NCT NCT01582243)
NCT ID: NCT01582243
Last Updated: 2016-11-03
Results Overview
HbA1c analysis will be performed on a blood sample obtained by study personnel.
COMPLETED
PHASE4
40 participants
Baseline, Week 24
2016-11-03
Participant Flow
Participant milestones
| Measure |
Vildagliptin Plus Metformin (SPC)
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Vildagliptin Plus Metformin (SPC)
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
Baseline characteristics by cohort
| Measure |
Vildagliptin Plus Metformin (SPC)
n=39 Participants
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
HbA1c analysis will be performed on a blood sample obtained by study personnel.
Outcome measures
| Measure |
Vildagliptin Plus Metformin (SPC)
n=39 Participants
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
|
-0.82 percentage
Standard Deviation 0.759
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
HbA1c analysis will be performed on a blood sample obtained by study personnel.
Outcome measures
| Measure |
Vildagliptin Plus Metformin (SPC)
n=39 Participants
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
|
-0.82 percentage
Standard Deviation 0.609
|
SECONDARY outcome
Timeframe: Baseline, week 12, week 24Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
FPG analysis will be performed on a blood sample obtained by study personnel.
Outcome measures
| Measure |
Vildagliptin Plus Metformin (SPC)
n=39 Participants
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24
Week 12
|
-20.6 mg/dL
Standard Deviation 25.2
|
|
Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24
Week 24
|
-19.9 mg/dL
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: Baseline, week, week 24Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
PPG analysis will be performed on a blood sample obtained by study personnel.
Outcome measures
| Measure |
Vildagliptin Plus Metformin (SPC)
n=39 Participants
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24
Week 12
|
-40.9 mg/dL
Standard Deviation 41.7
|
|
Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24
Week 24
|
-38.3 mg/dL
Standard Deviation 50.6
|
SECONDARY outcome
Timeframe: Baseline, week 24Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.
Outcome measures
| Measure |
Vildagliptin Plus Metformin (SPC)
n=38 Participants
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week
|
-12.8 mg/dL
Standard Deviation 31.8
|
SECONDARY outcome
Timeframe: week 12, week 24Population: Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement
Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.
Outcome measures
| Measure |
Vildagliptin Plus Metformin (SPC)
n=39 Participants
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment
HbA1c ≤ 6.5% Week 12
|
64.1 percentage of participants
|
|
The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment
HbA1c ≤ 6.5% Week 24
|
66.7 percentage of participants
|
|
The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment
HbA1c ≤ 7.0% Week 12
|
92.3 percentage of participants
|
|
The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment
HbA1c ≤ 7.0% Week 24
|
87.2 percentage of participants
|
Adverse Events
Vildagliptin Plus Metformin (SPC)
Serious adverse events
| Measure |
Vildagliptin Plus Metformin (SPC)
n=40 participants at risk
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Reproductive system and breast disorders
Pelvic cyst
|
2.5%
1/40
|
Other adverse events
| Measure |
Vildagliptin Plus Metformin (SPC)
n=40 participants at risk
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
1/40
|
|
Cardiac disorders
Myocardial ischaemia
|
2.5%
1/40
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40
|
|
Gastrointestinal disorders
Abdominal adhesions
|
2.5%
1/40
|
|
Gastrointestinal disorders
Constipation
|
7.5%
3/40
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
1/40
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
2.5%
1/40
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.5%
1/40
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
2.5%
1/40
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.5%
1/40
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40
|
|
General disorders
Oedema peripheral
|
2.5%
1/40
|
|
General disorders
Pyrexia
|
2.5%
1/40
|
|
Infections and infestations
Bronchitis
|
2.5%
1/40
|
|
Infections and infestations
Diverticulitis
|
2.5%
1/40
|
|
Infections and infestations
Hepatitis B
|
2.5%
1/40
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40
|
|
Infections and infestations
Tonsillitis
|
2.5%
1/40
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
5/40
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40
|
|
Infections and infestations
Vaginal infection
|
7.5%
3/40
|
|
Infections and infestations
Vulvovaginitis
|
7.5%
3/40
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
1/40
|
|
Injury, poisoning and procedural complications
Laceration
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.5%
1/40
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.5%
1/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
2.5%
1/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
2.5%
1/40
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.5%
1/40
|
|
Nervous system disorders
Sciatica
|
2.5%
1/40
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40
|
|
Reproductive system and breast disorders
Breast pain
|
2.5%
1/40
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.5%
1/40
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
1/40
|
Additional Information
Study Director
Novartis Pharmaceuticals
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