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Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01582243
Recruitment Status : Completed
First Posted : April 20, 2012
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Intervention Drug: Vildagliptin
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Period Title: Overall Study
Started 40
Completed 37
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             1
Lost to Follow-up             1
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
Baseline characteristics used the 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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
53.9  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
30
  76.9%
Male
9
  23.1%
1.Primary Outcome
Title Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Hide Description HbA1c analysis will be performed on a blood sample obtained by study personnel.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description:
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: percentage
-0.82  (0.759)
2.Secondary Outcome
Title Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Hide Description HbA1c analysis will be performed on a blood sample obtained by study personnel.
Time Frame Baseline, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description:
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: percentage
-0.82  (0.609)
3.Secondary Outcome
Title Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24
Hide Description FPG analysis will be performed on a blood sample obtained by study personnel.
Time Frame Baseline, week 12, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description:
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 12 -20.6  (25.2)
Week 24 -19.9  (31.9)
4.Secondary Outcome
Title Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24
Hide Description PPG analysis will be performed on a blood sample obtained by study personnel.
Time Frame Baseline, week, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description:
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 12 -40.9  (41.7)
Week 24 -38.3  (50.6)
5.Secondary Outcome
Title Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week
Hide Description 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.
Time Frame Baseline, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description:
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: mg/dL
-12.8  (31.8)
6.Secondary Outcome
Title The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment
Hide Description Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.
Time Frame week 12, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description:
Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: percentage of participants
HbA1c ≤ 6.5% Week 12 64.1
HbA1c ≤ 6.5% Week 24 66.7
HbA1c ≤ 7.0% Week 12 92.3
HbA1c ≤ 7.0% Week 24 87.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vildagliptin Plus Metformin (SPC)
Hide Arm/Group Description Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
All-Cause Mortality
Vildagliptin Plus Metformin (SPC)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vildagliptin Plus Metformin (SPC)
Affected / at Risk (%)
Total   1/40 (2.50%) 
Reproductive system and breast disorders   
Pelvic cyst  1  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vildagliptin Plus Metformin (SPC)
Affected / at Risk (%)
Total   23/40 (57.50%) 
Blood and lymphatic system disorders   
Neutropenia  1  1/40 (2.50%) 
Cardiac disorders   
Myocardial ischaemia  1  1/40 (2.50%) 
Palpitations  1  1/40 (2.50%) 
Gastrointestinal disorders   
Abdominal adhesions  1  1/40 (2.50%) 
Constipation  1  3/40 (7.50%) 
Dyspepsia  1  1/40 (2.50%) 
Gastritis  1  1/40 (2.50%) 
Gastritis haemorrhagic  1  1/40 (2.50%) 
Gastrooesophageal reflux disease  1  1/40 (2.50%) 
Irritable bowel syndrome  1  1/40 (2.50%) 
Mouth ulceration  1  1/40 (2.50%) 
Vomiting  1  1/40 (2.50%) 
General disorders   
Oedema peripheral  1  1/40 (2.50%) 
Pyrexia  1  1/40 (2.50%) 
Infections and infestations   
Bronchitis  1  1/40 (2.50%) 
Diverticulitis  1  1/40 (2.50%) 
Hepatitis B  1  1/40 (2.50%) 
Nasopharyngitis  1  2/40 (5.00%) 
Tonsillitis  1  1/40 (2.50%) 
Upper respiratory tract infection  1  5/40 (12.50%) 
Urinary tract infection  1  1/40 (2.50%) 
Vaginal infection  1  3/40 (7.50%) 
Vulvovaginitis  1  3/40 (7.50%) 
Injury, poisoning and procedural complications   
Contusion  1  1/40 (2.50%) 
Laceration  1  1/40 (2.50%) 
Metabolism and nutrition disorders   
Hypercholesterolaemia  1  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders   
Spinal osteoarthritis  1  1/40 (2.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign breast neoplasm  1  1/40 (2.50%) 
Benign ovarian tumour  1  1/40 (2.50%) 
Nervous system disorders   
Carpal tunnel syndrome  1  1/40 (2.50%) 
Sciatica  1  1/40 (2.50%) 
Psychiatric disorders   
Anxiety  1  1/40 (2.50%) 
Reproductive system and breast disorders   
Breast pain  1  1/40 (2.50%) 
Pelvic adhesions  1  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/40 (2.50%) 
Bronchiectasis  1  1/40 (2.50%) 
Bronchitis chronic  1  1/40 (2.50%) 
Rhinorrhoea  1  1/40 (2.50%) 
Skin and subcutaneous tissue disorders   
Dermatitis allergic  1  2/40 (5.00%) 
Rash  1  2/40 (5.00%) 
Urticaria  1  1/40 (2.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01582243     History of Changes
Other Study ID Numbers: CLAF237ATW03
First Submitted: April 18, 2012
First Posted: April 20, 2012
Results First Submitted: September 15, 2016
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016