Trial Outcomes & Findings for Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes (NCT NCT01155284)
NCT ID: NCT01155284
Last Updated: 2017-09-18
Results Overview
Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Month 12
Results posted on
2017-09-18
Participant Flow
Four centers screened 79 participants were screened between August 2010 and May 2012. Participants aged 11-36 years, diagnosed with type 1 diabetes within the past 6 months were recruited. 9 participants were not randomized as 7 were deemed ineligible and 2 were lost to follow-up.
At a screening visit, participants underwent procedures to establish that all inclusion criteria were met and none of the exclusion criteria were met. All participants and if applicable, guardians provided written informed consent/assent at screening.
Participant milestones
| Measure |
Sitagliptin and Lansoprazole
Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
|
Placebo
Placebo: Matching placebo was given daily for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
23
|
|
Overall Study
COMPLETED
|
40
|
18
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Sitagliptin and Lansoprazole
Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
|
Placebo
Placebo: Matching placebo was given daily for 12 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Sitagliptin and Lansoprazole
n=46 Participants
Oral Sitagliptin (100 mg for those age 18 -45 years, 50 mg for those age 11-17 years) and Lansoprazole (60 mg for those 18-45 years, 30 mg for those age 11-17 years for 12 months. Participants were then followed for an additional 12 months.
|
Placebo
n=22 Participants
Matching placebo will be given daily for 12 months. Participants were then followed for an additional 12 months.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Insulin use (units/kg per day)
|
0.43 units/kg per day
STANDARD_DEVIATION 0.22 • n=5 Participants
|
0.38 units/kg per day
STANDARD_DEVIATION 0.17 • n=7 Participants
|
0.41 units/kg per day
STANDARD_DEVIATION 0.20 • n=5 Participants
|
|
Age, Customized
Age (years)
|
15.5 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
17.6 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
16.2 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Days Post diagnosis
|
102.8 Days
STANDARD_DEVIATION 51.8 • n=5 Participants
|
104.7 Days
STANDARD_DEVIATION 52.8 • n=7 Participants
|
103.4 Days
STANDARD_DEVIATION 51.7 • n=5 Participants
|
|
GAD antibody positive
|
42 participants
n=5 Participants
|
22 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
HLA DR Allele - Neither DR3 nor DR4
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
HLA DR Allele - DR3 only
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
HLA DR4 Allele only
|
19 participants
n=5 Participants
|
6 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
HLA DR Allele - Both DR3 and DR4
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
2 -hour C-peptide Area Under Curve Result in Response to Standardized Mixed Meal Tolerance Test
|
656 pmol/L
STANDARD_DEVIATION 385 • n=5 Participants
|
747 pmol/L
STANDARD_DEVIATION 468 • n=7 Participants
|
686 pmol/L
STANDARD_DEVIATION 413 • n=5 Participants
|
|
Glucose (mmol/L)
|
10.61 mmol/L
STANDARD_DEVIATION 3.35 • n=5 Participants
|
10.47 mmol/L
STANDARD_DEVIATION 3.43 • n=7 Participants
|
10.56 mmol/L
STANDARD_DEVIATION 3.35 • n=5 Participants
|
|
HbA1c (%)
|
7.19 %
STANDARD_DEVIATION 1.09 • n=5 Participants
|
7.15 %
STANDARD_DEVIATION 1.13 • n=7 Participants
|
7.18 %
STANDARD_DEVIATION 1.09 • n=5 Participants
|
|
IDA-HbA1c (%)
|
8.9 %
STANDARD_DEVIATION 1.53 • n=5 Participants
|
8.68 %
STANDARD_DEVIATION 1.43 • n=7 Participants
|
8.83 %
STANDARD_DEVIATION 1.49 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Of the 70 subjects randomized, 58 completed treatment and analysis.
Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.
Outcome measures
| Measure |
Sitagliptin and Lansoprazole
n=40 Participants
Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) given daily for 12 months.
* Subjects age 11-17 years at Visit 2 will take 1 capsule once daily
* Subjects age 18-45 years at Visit 2 will take 2 capsules once daily
|
Placebo
n=18 Participants
Matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
|
|---|---|---|
|
2 Hour C-peptide AUC in Response to MMTT
|
358 pmol/L
Interval 308.0 to 563.0
|
495 pmol/L
Interval 299.0 to 675.0
|
SECONDARY outcome
Timeframe: Month 6Population: Of the 70 subjects randomized, 58 completed treatment and analysis.
Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90, and 120 minutes post-meal.
Outcome measures
| Measure |
Sitagliptin and Lansoprazole
n=40 Participants
Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) given daily for 12 months.
* Subjects age 11-17 years at Visit 2 will take 1 capsule once daily
* Subjects age 18-45 years at Visit 2 will take 2 capsules once daily
|
Placebo
n=18 Participants
Matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
|
|---|---|---|
|
2 Hour C-peptide AUC in Response to MMTT
|
485 pmol/L
Interval 431.0 to 683.0
|
675 pmol/L
Interval 495.0 to 860.0
|
Adverse Events
Sitagliptin and Lansoprazole
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitagliptin and Lansoprazole
n=46 participants at risk
Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) taken for 12 months.
* Subjects age 11-17 years at Visit 2 will take 1 capsule once daily
* Subjects age 18-45 years at Visit 2 will take 2 capsules once daily
|
Placebo
n=22 participants at risk
Matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Carcinoma of the Thyroid
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected from the August 2010 to May 2013
|
0.00%
0/22 • Adverse event data was collected from the August 2010 to May 2013
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.2%
1/46 • Number of events 1 • Adverse event data was collected from the August 2010 to May 2013
|
0.00%
0/22 • Adverse event data was collected from the August 2010 to May 2013
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/46 • Adverse event data was collected from the August 2010 to May 2013
|
4.5%
1/22 • Number of events 1 • Adverse event data was collected from the August 2010 to May 2013
|
Other adverse events
| Measure |
Sitagliptin and Lansoprazole
n=46 participants at risk
Sitagliptin and Lansoprazole: Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) taken for 12 months.
* Subjects age 11-17 years at Visit 2 will take 1 capsule once daily
* Subjects age 18-45 years at Visit 2 will take 2 capsules once daily
|
Placebo
n=22 participants at risk
Matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
23.9%
11/46 • Number of events 15 • Adverse event data was collected from the August 2010 to May 2013
|
13.6%
3/22 • Number of events 6 • Adverse event data was collected from the August 2010 to May 2013
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
3/46 • Number of events 3 • Adverse event data was collected from the August 2010 to May 2013
|
31.8%
7/22 • Number of events 9 • Adverse event data was collected from the August 2010 to May 2013
|
|
Gastrointestinal disorders
Nausea
|
17.4%
8/46 • Number of events 8 • Adverse event data was collected from the August 2010 to May 2013
|
9.1%
2/22 • Number of events 5 • Adverse event data was collected from the August 2010 to May 2013
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
10/46 • Number of events 10 • Adverse event data was collected from the August 2010 to May 2013
|
22.7%
5/22 • Number of events 5 • Adverse event data was collected from the August 2010 to May 2013
|
|
Infections and infestations
Infections and Infestations-Other
|
17.4%
8/46 • Number of events 14 • Adverse event data was collected from the August 2010 to May 2013
|
9.1%
2/22 • Number of events 2 • Adverse event data was collected from the August 2010 to May 2013
|
|
Infections and infestations
Upper Respiratory Infection
|
43.5%
20/46 • Number of events 33 • Adverse event data was collected from the August 2010 to May 2013
|
40.9%
9/22 • Number of events 13 • Adverse event data was collected from the August 2010 to May 2013
|
|
Investigations
Neutrophil count decreased
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected from the August 2010 to May 2013
|
13.6%
3/22 • Number of events 5 • Adverse event data was collected from the August 2010 to May 2013
|
|
Nervous system disorders
Headache
|
32.6%
15/46 • Number of events 16 • Adverse event data was collected from the August 2010 to May 2013
|
27.3%
6/22 • Number of events 9 • Adverse event data was collected from the August 2010 to May 2013
|
Additional Information
Kurt J. Griffin, PhD, MD, Director of Clinical Trials
Sanford Research
Phone: 6053126000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place