Trial Outcomes & Findings for Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin (NCT NCT01871558)
NCT ID: NCT01871558
Last Updated: 2016-04-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
42 participants
Primary outcome timeframe
24 weeks
Results posted on
2016-04-21
Participant Flow
Participant milestones
| Measure |
Metformin/Vildagliptin + Basal Insulin
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Metformin/Vildagliptin + Basal Insulin
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Overall Study
Other reason
|
0
|
1
|
|
Overall Study
antidiabetic drug prematurely stopped
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin
Baseline characteristics by cohort
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=21 Participants
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=21 Participants
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 7.80 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: safety population
Outcome measures
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=21 Participants
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=21 Participants
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms
|
22.2 percent of participants
|
45.0 percent of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: ITT population
Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%
Outcome measures
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=19 Participants
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=19 Participants
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events
|
44.4 percent of participants
|
47.4 percent of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population
Outcome measures
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=19 Participants
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=19 Participants
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Change From Baseline in HbA1c to Week 24 in Both Treatment Arms
baseline
|
8.2 HbA1c percent
Standard Deviation 0.56
|
8.2 HbA1c percent
Standard Deviation 0.42
|
|
Change From Baseline in HbA1c to Week 24 in Both Treatment Arms
week 24
|
7.2 HbA1c percent
Standard Deviation 0.71
|
7.4 HbA1c percent
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Safety Population
Outcome measures
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=21 Participants
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=21 Participants
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Change From Baseline in Body Weight in Both Treatment Arms
|
-0.3 kg
Standard Deviation 2.51
|
1.4 kg
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Week 24Population: ITT population
Outcome measures
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=19 Participants
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=19 Participants
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Mean Daily Insulin Dose at Week 24
|
33.0 (U/d)
Standard Deviation 23.08
|
19.8 (U/d)
Standard Deviation 13.83
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: ITT population
Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) \< 70 mg/dL
Outcome measures
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=19 Participants
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=19 Participants
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Percentage of Patients With Severe and Confirmed Hypoglycemic Events
|
0.0 percent participants
|
0.0 percent participants
|
SECONDARY outcome
Timeframe: week 24Population: ITT population
HbA1c \<= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain
Outcome measures
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=19 Participants
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=19 Participants
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline)
|
27.8 percent of participants
|
21.1 percent of participants
|
Adverse Events
Metformin/Vildagliptin + Basal Insulin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SU+Metformin + Basal Insulin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin/Vildagliptin + Basal Insulin
n=21 participants at risk
Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
SU+Metformin + Basal Insulin
n=21 participants at risk
Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
|
|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/21
|
4.8%
1/21
|
|
Eye disorders
Visual impairment
|
0.00%
0/21
|
4.8%
1/21
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21
|
9.5%
2/21
|
|
General disorders
Fatigue
|
0.00%
0/21
|
4.8%
1/21
|
|
General disorders
Injection site pain
|
0.00%
0/21
|
4.8%
1/21
|
|
Infections and infestations
Tooth abscess
|
4.8%
1/21
|
0.00%
0/21
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21
|
4.8%
1/21
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/21
|
4.8%
1/21
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/21
|
4.8%
1/21
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21
|
4.8%
1/21
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21
|
4.8%
1/21
|
|
Nervous system disorders
Headache
|
0.00%
0/21
|
4.8%
1/21
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/21
|
4.8%
1/21
|
|
Nervous system disorders
Sciatica
|
0.00%
0/21
|
4.8%
1/21
|
|
Psychiatric disorders
Depression
|
0.00%
0/21
|
4.8%
1/21
|
|
Renal and urinary disorders
Renal colic
|
4.8%
1/21
|
0.00%
0/21
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/21
|
4.8%
1/21
|
|
Vascular disorders
Hypertension
|
0.00%
0/21
|
4.8%
1/21
|
Additional Information
Clinical Disclosure Office
Novartis Pharmaceuticals
Phone: 862-778-8300
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER