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Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes (REPAIR-T1D)

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ClinicalTrials.gov Identifier: NCT01155284
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : September 18, 2017
Last Update Posted : September 18, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Kurt Griffin, Sanford Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: Sitagliptin and Lansoprazole
Drug: Placebo
Enrollment 70
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Sitagliptin and Lansoprazole Placebo
Hide Arm/Group Description 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: Matching placebo was given daily for 12 months.
Period Title: Overall Study
Started 47 23
Completed 40 18
Not Completed 7 5
Reason Not Completed
Withdrawal by Subject             4             3
Lost to Follow-up             1             2
Physician Decision             1             0
Adverse Event             1             0
Arm/Group Title Sitagliptin and Lansoprazole Placebo Total
Hide Arm/Group Description 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. Matching placebo will be given daily for 12 months. Participants were then followed for an additional 12 months. Total of all reporting groups
Overall Number of Baseline Participants 46 22 68
Hide Baseline Analysis Population Description
70 participants were randomized. After randomization, 2 participants withdrew (one was from treatment group and one from placebo group) before taking any drugs, leaving 46 participants in the active treatment group and 22 in the placebo.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age (years) Number Analyzed 46 participants 22 participants 68 participants
15.5  (5.1) 17.6  (6.9) 16.2  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 22 participants 68 participants
Female
19
  41.3%
10
  45.5%
29
  42.6%
Male
27
  58.7%
12
  54.5%
39
  57.4%
Days Post diagnosis  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 46 participants 22 participants 68 participants
102.8  (51.8) 104.7  (52.8) 103.4  (51.7)
GAD antibody positive  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 22 participants 68 participants
42 22 64
HLA DR Allele - Neither DR3 nor DR4  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 22 participants 68 participants
2 3 5
HLA DR Allele - DR3 only  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 22 participants 68 participants
11 7 18
HLA DR4 Allele only  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 22 participants 68 participants
19 6 25
HLA DR Allele - Both DR3 and DR4  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 22 participants 68 participants
14 6 20
Insulin use (units/kg per day)  
Mean (Standard Deviation)
Unit of measure:  Units/kg per day
Number Analyzed 46 participants 22 participants 68 participants
0.43  (0.22) 0.38  (0.17) 0.41  (0.20)
2 -hour C-peptide Area Under Curve Result in Response to Standardized Mixed Meal Tolerance Test   [1] 
Mean (Standard Deviation)
Unit of measure:  pmol/L
Number Analyzed 46 participants 22 participants 68 participants
656  (385) 747  (468) 686  (413)
[1]
Measure Description: C-peptide reflects how much insulin pancreatic beta cells are making. The MMTT measures how much insulin can be made. Blood samples for C-peptide were collected at baseline, 15, 30, 60, 90 and 120 minutes post-meal. Results are presented as the time weighted average concentration. To maintain consistency with prior reports, this has been labeled as “AUC,” although it may be more accurate to describe this as an AUC mean (pmol/L), [true AUC (pmol*min/L) / 120 minutes]. Larger numbers are better, reflecting preservation of insulin production.
Glucose (mmol/L)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 46 participants 22 participants 68 participants
10.61  (3.35) 10.47  (3.43) 10.56  (3.35)
[1]
Measure Description: time weighed mean during mixed meal test
HbA1c (%)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 46 participants 22 participants 68 participants
7.19  (1.09) 7.15  (1.13) 7.18  (1.09)
IDA-HbA1c (%)  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 46 participants 22 participants 68 participants
8.9  (1.53) 8.68  (1.43) 8.83  (1.49)
1.Primary Outcome
Title 2 Hour C-peptide AUC in Response to MMTT
Hide Description Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 70 subjects randomized, 58 completed treatment and analysis.
Arm/Group Title Sitagliptin and Lansoprazole Placebo
Hide Arm/Group Description:

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
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.
Overall Number of Participants Analyzed 40 18
Median (95% Confidence Interval)
Unit of Measure: pmol/L
358
(308 to 563)
495
(299 to 675)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin and Lansoprazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments The p value between treatment groups of C-peptide log (AUC+1) with covariate analysis adjusted for age, sex, baseline C-peptide concentration and duration of diabetes.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title 2 Hour C-peptide AUC in Response to MMTT
Hide Description Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90, and 120 minutes post-meal.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 70 subjects randomized, 58 completed treatment and analysis.
Arm/Group Title Sitagliptin and Lansoprazole Placebo
Hide Arm/Group Description:
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.
Matching placebo will be given daily for 12 months. Participants were then followed for an additional 12 months.
Overall Number of Participants Analyzed 40 18
Median (95% Confidence Interval)
Unit of Measure: pmol/L
485
(431 to 683)
675
(495 to 860)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin and Lansoprazole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.869
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse event data was collected from the August 2010 to May 2013
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin and Lansoprazole Placebo
Hide Arm/Group Description

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
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.
All-Cause Mortality
Sitagliptin and Lansoprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin and Lansoprazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/46 (4.35%)      1/22 (4.55%)    
Gastrointestinal disorders     
Abdominal Pain  1/46 (2.17%)  1 0/22 (0.00%)  0
Appendicitis  0/46 (0.00%)  0 1/22 (4.55%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Papillary Carcinoma of the Thyroid  1/46 (2.17%)  1 0/22 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sitagliptin and Lansoprazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/46 (95.65%)      21/22 (95.45%)    
Gastrointestinal disorders     
Abdominal Pain  11/46 (23.91%)  15 3/22 (13.64%)  6
Diarrhea  3/46 (6.52%)  3 7/22 (31.82%)  9
Nausea  8/46 (17.39%)  8 2/22 (9.09%)  5
Vomiting  10/46 (21.74%)  10 5/22 (22.73%)  5
Infections and infestations     
Infections and Infestations-Other  8/46 (17.39%)  14 2/22 (9.09%)  2
Upper Respiratory Infection  20/46 (43.48%)  33 9/22 (40.91%)  13
Investigations     
Neutrophil count decreased  2/46 (4.35%)  2 3/22 (13.64%)  5
Nervous system disorders     
Headache  15/46 (32.61%)  16 6/22 (27.27%)  9
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kurt J. Griffin, PhD, MD, Director of Clinical Trials
Organization: Sanford Research
Phone: 6053126000
EMail: kurt.griffin@sanfordhealth.org
Layout table for additonal information
Responsible Party: Kurt Griffin, Sanford Health
ClinicalTrials.gov Identifier: NCT01155284     History of Changes
Other Study ID Numbers: REPAIR-T1D
First Submitted: June 3, 2010
First Posted: July 1, 2010
Results First Submitted: December 18, 2014
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017