Trial Outcomes & Findings for Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial. (NCT NCT01991197)
NCT ID: NCT01991197
Last Updated: 2020-05-14
Results Overview
Psoriasis area and severity index (0-72), higher scores worse outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
16 weeks
Results posted on
2020-05-14
Participant Flow
From April 25 2014 to April 22 2015 20 participants were recruited from Dermatology and Endocrinology outpatient clinics and through national newspaper advertisements.
Participant milestones
| Measure |
Sitagliptin
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Sitagliptin
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 years
n=99 Participants
|
59.8 years
n=107 Participants
|
58.4 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Ireland
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
PASI
|
9.5 units on a scale
n=99 Participants
|
9.4 units on a scale
n=107 Participants
|
9.4 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPsoriasis area and severity index (0-72), higher scores worse outcome
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Change in the Psoriasis Area and Severity Index (PASI) From Baseline to 16 Weeks in Psoriasis Patients With Type 2 Diabetes Treated With Sitagliptin Compared to Patients Treated With Gliclazide.
|
9.5 score on a scale
Interval 7.8 to 9.6
|
9.4 score on a scale
Interval 7.6 to 12.0
|
SECONDARY outcome
Timeframe: 32 weeksDosage: Sitagliptin: 100mg daily, or 50mg daily for participants with moderate kidney disease Gliclazide: 80-320 mg daily. Secondary outcomes: the number participants with adverse events.
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Number of Patricipants in the Sitagliptin and Gliclazide Arms With Adverse Events at 32 Weeks.
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 16 weeksDermatology life quality index (a skin related quality of life measure) (0-10), higher score worse outcome EQ-5D Euroqol 5 item quality of life index comprising 5 dimensions mobility, self-care, usual activities, pain, anxiety. An index can be derived from these 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state and minimum score indicating the worst health outcome -0.594. HADS Hospital anxiety and depression scale 0-16 for anxiety and 0-16 for depression, higher score worse outcome HAQ-8 Stanford 8 item disability scale. Scoring is from 0 (without any difficulty) to 3 (unable to do). The 8 scores from the 8 sections are summed and divided by 8. The result is the disability index (range 0-3 with 25 possible values). A
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
DLQI
|
0.0 score on a scale
Interval -1.0 to 1.0
|
-1.0 score on a scale
Interval -5.0 to 1.0
|
|
The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
HAQ-8
|
0.0 score on a scale
Interval 0.0 to 0.0
|
0.0 score on a scale
Interval 0.0 to 0.0
|
|
The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
HADS Anxiety
|
-1 score on a scale
Interval -3.0 to -1.0
|
0 score on a scale
Interval -3.0 to 0.0
|
|
The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
HADS Depression
|
0 score on a scale
Interval -1.0 to 1.0
|
0 score on a scale
Interval -3.0 to 1.0
|
|
The Change in Quality of Life Scores From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
EQ-5D
|
0 score on a scale
Interval 0.0 to 0.0
|
-0.2 score on a scale
Interval -0.3 to 0.0
|
SECONDARY outcome
Timeframe: 16 weeksSecondary outcomes: d. number or participants who acheived a greater than 50% reduction in PASI from baseline (PASI-50); e. number of participants who achieved PASI-75 and PASI-90.
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on Other Efficacy Endpoints.
PASI 50
|
1 Participants
|
1 Participants
|
|
The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on Other Efficacy Endpoints.
PASI 75
|
0 Participants
|
0 Participants
|
|
The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on Other Efficacy Endpoints.
PASI 90
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16 weeksHigh sensitivity C-reactive protein (range 0 - no maximum)
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Change in Levels of High Sensitivity C-reactive Protein From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
|
0 µg/ml
Interval -0.83 to 0.16
|
8.4 µg/ml
Interval 2.37 to 11.19
|
SECONDARY outcome
Timeframe: 16 weeksSecondary outcomes: The change in serum concentrations of the cytokines tumour necrosis factor alpha (TNFα) Range: 0-no maximum
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Serum Cytokine Tumour Necrosis Factor Alpha.
|
0 pg/ml
Interval -2.08 to 0.0
|
0 pg/ml
Interval -1.64 to 10.87
|
SECONDARY outcome
Timeframe: baseline and 32 weeksPopulation: The change in PASI at 32 weeks
Psoriasis area and severity index 0-72, higher score worse outcome
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Change in PASI From Baseline to 32 Weeks in Psoriasis Patients With Type 2 Diabetes Treated With Sitagliptin Compared to Patients Treated With Gliclazide.
|
3 score on a scale
Interval 2.0 to 5.6
|
1.8 score on a scale
Interval 0.3 to 3.0
|
SECONDARY outcome
Timeframe: 16 weeksThe change in weight from baseline to 16 weeks measured in kg
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Change in Weight From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
|
-0.5 kg
Interval -1.3 to 0.0
|
-0.6 kg
Interval -2.9 to 2.6
|
SECONDARY outcome
Timeframe: 16 weeksThe change in systolic blood pressure from baseline to 16 weeks measured in kg
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Change in Levels of Systolic Blood Pressure From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
|
4 mmHg
Interval -2.0 to 8.0
|
-9 mmHg
Interval -17.0 to 9.0
|
SECONDARY outcome
Timeframe: 16 weeksThe change in glucose from baseline to 16 weeks
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Change in Levels of Serum Glucose From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
|
-0.2 mmol/L
Interval -1.3 to 0.8
|
-0.1 mmol/L
Interval -1.7 to 0.3
|
SECONDARY outcome
Timeframe: 16 weeksThe change in total cholesterol from baseline to 16 weeks
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Change in Levels of Total Cholesterol From Baseline to 16 Weeks in the Sitagliptin and Gliclazide Arms.
|
0.1 mmol/L
Interval -0.3 to 0.1
|
-0.1 mmol/L
Interval -0.5 to 0.1
|
SECONDARY outcome
Timeframe: 16 weeksSecondary outcomes: The change in serum concentrations of the cytokine interleukin-23 (IL-23) Range: 0-no maximum
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Effects of Treatment With Sitagliptin and Treatment With Gliclazide From Baseline to 16 Weeks on Serum Levels Interleukin-23.
|
0 pg/ml
Interval 0.0 to 0.0
|
0 pg/ml
Interval 0.0 to 46.1
|
SECONDARY outcome
Timeframe: 16 weeksSecondary outcomes: The change in serum concentrations of the cytokine interleukin-17 (IL-17) Range: 0-no maximum
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Effects of Treatment With Sitagliptin and Treatment With Gliclazide From Baseline to 16 Weeks on Serum Levels Interleukin-17.
|
0 pg/ml
Interval 0.0 to 0.0
|
0 pg/ml
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 16 weeksSecondary outcomes: The change in serum concentrations of the adipokine leptin Range: 0-no maximum
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Effects of Treatment With Sitagliptin and Treatment With Gliclazide on the Change in Serum Leptin From Baseline to 16 Weeks.
|
-0.07 pg/ml
Interval -2.42 to 0.0
|
0.43 pg/ml
Interval -3.25 to 8.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Skin cytokine endpoints
Interleukin 17 levels in skin (0-no maximum)
Outcome measures
| Measure |
Sitagliptin
n=9 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Effect of Treatment With Sitagliptin and With Gliclazide From Baseline to 16 Weeks on the Change in Interleukin-17 Levels in the Skin (in a Sub-group of Participants Willing to Undergo Skin Biopsies).
|
3.41 dCt
Interval 0.0 to 3.85
|
2.09 dCt
Interval 1.17 to 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeksPopulation: Skin cytokine endpoints
Dipeptidyl peptidase-4 levels levels in skin (0-no maximum)
Outcome measures
| Measure |
Sitagliptin
n=11 Participants
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=9 Participants
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
The Effect of Treatment With Sitagliptin and With Gliclazide From Baseline to 16 Weeks on the Change in Dipeptidyl Peptidase-4 Levels in the Skin (in a Sub-group of Participants Willing to Undergo Skin Biopsies).
|
-1.12 dCt
Interval -2.63 to 0.39
|
0 dCt
Interval -0.43 to 4.8
|
Adverse Events
Sitagliptin
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Gliclazide
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin
n=9 participants at risk
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 participants at risk
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
Nervous system disorders
Clinically isolated syndrome
|
0.00%
0/9 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
9.1%
1/11 • Number of events 1 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/9 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
9.1%
1/11 • Number of events 1 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
|
Nervous system disorders
Vasovagal episode leading to anoxic seizure
|
11.1%
1/9 • Number of events 1 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
0.00%
0/11 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
Other adverse events
| Measure |
Sitagliptin
n=9 participants at risk
Double blind phase (week 0-16):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
Placebo Comparator: Gliclazide matched placebo One gliclazide matched placebo capsule daily for 4 weeks. If no severe hypoglycaemic episodes one gliclazide matched placebo capsule twice daily for 4 weeks. If no severe hypoglycaemic episodes two gliclazide matched placebo capsules twice daily for 8 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
Gliclazide
n=11 participants at risk
Double-blind phase (week 0-16):
Gliclazide 80mg once daily for 4 weeks Then if no severe hypoglycaemic episodes increase to Gliclazide 80mg twice daily for 4 weeks.
Then if no severe hypoglycaemic episodes increase to Gliclazide 160mg twice daily for 8 weeks Placebo Comparator: Sitagliptin matched placebo Two tablets (or one tablet in participants with moderate kidney disease) once daily for 16 weeks.
Open-label phase (week 16-32):
Sitagliptin two 50mg tablets (or one 50mg in participants with moderate kidney disease) once daily for 16 weeks.
|
|---|---|---|
|
Endocrine disorders
Hypoglycaemia
|
11.1%
1/9 • Number of events 1 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
81.8%
9/11 • Number of events 16 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infections
|
22.2%
2/9 • Number of events 3 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
27.3%
3/11 • Number of events 5 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
11.1%
1/9 • Number of events 1 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
18.2%
2/11 • Number of events 2 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
|
Musculoskeletal and connective tissue disorders
Cellulitis
|
11.1%
1/9 • Number of events 1 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
9.1%
1/11 • Number of events 2 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
|
Endocrine disorders
Hyperglycaemia
|
11.1%
1/9 • Number of events 1 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
9.1%
1/11 • Number of events 1 • Participants attended the clinical research centre 9 times over the course of 40 weeks and adverse event data was collected at each visit after the baseline visit.
|
Additional Information
Dr Maeve Lynch
Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place