Trial Outcomes & Findings for A Clinical Trial to Prevent New Onset Diabetes After Transplantation (NCT NCT01683331)
NCT ID: NCT01683331
Last Updated: 2019-03-20
Results Overview
NODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
251 participants
Primary outcome timeframe
12 months
Results posted on
2019-03-20
Participant Flow
Of 42 participants randomized prior to kidney transplantation at University of Michigan, 6 did not undergo study procedure due to medical conditions that developed in the immediate postoperative period which prevented them from going forward in the study. Data are not available on the 209 participants randomized through the University of Austria.
Participant milestones
| Measure |
Insulin Treatment for Hyperglycemia
NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG \> 240, NPH initiation: 14, dose increases by 4; For pts. with CPG \> 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG \> 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG \> 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-\<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-\<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG \<60 mg/dl, NPH initiation: 0, ½ of previous dose.
|
Standard of Care
Patients assigned in this arm will receive standard of care following their kidney transplantation.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
Began Dosage
|
18
|
18
|
|
Overall Study
12 Months
|
18
|
18
|
|
Overall Study
24 Months
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Baseline characteristics by cohort
| Measure |
Insulin Treatment for Hyperglycemia
n=18 Participants
NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG \> 240, NPH initiation: 14, dose increases by 4; For pts. with CPG \> 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG \> 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG \> 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-\<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-\<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG \<60 mg/dl, NPH initiation: 0, ½ of previous dose.
|
Standard of Care
n=18 Participants
Patients assigned in this arm will receive standard of care following their kidney transplantation.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria.
Outcome measures
| Measure |
Insulin Treatment for Hyperglycemia
n=18 Participants
NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG \> 240, NPH initiation: 14, dose increases by 4; For pts. with CPG \> 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG \> 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG \> 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-\<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-\<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG \<60 mg/dl, NPH initiation: 0, ½ of previous dose.
|
Standard of Care
n=18 Participants
Patients assigned in this arm will receive standard of care following their kidney transplantation.
|
|---|---|---|
|
The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 monthsNODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours OGTT values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy;
Outcome measures
| Measure |
Insulin Treatment for Hyperglycemia
n=18 Participants
NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG \> 240, NPH initiation: 14, dose increases by 4; For pts. with CPG \> 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG \> 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG \> 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-\<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-\<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG \<60 mg/dl, NPH initiation: 0, ½ of previous dose.
|
Standard of Care
n=18 Participants
Patients assigned in this arm will receive standard of care following their kidney transplantation.
|
|---|---|---|
|
The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12 and 24 monthsFollowing American Diabetes Association's definition: Impaired fasting glycemia: fasting glucose levels between 100 and 125 mg/dl; Impaired glucose tolerance: 2 hours' OGTT values between 140 and 199 mg/dl;
Outcome measures
Outcome data not reported
Adverse Events
Insulin Treatment for Hyperglycemia
Serious events: 15 serious events
Other events: 15 other events
Deaths: 0 deaths
Standard of Care
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Treatment for Hyperglycemia
n=18 participants at risk
NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG \> 240, NPH initiation: 14, dose increases by 4; For pts. with CPG \> 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG \> 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG \> 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-\<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-\<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG \<60 mg/dl, NPH initiation: 0, ½ of previous dose.
|
Standard of Care
n=18 participants at risk
Patients assigned in this arm will receive standard of care following their kidney transplantation.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
50.0%
9/18 • Number of events 9 • 24 months
|
44.4%
8/18 • Number of events 9 • 24 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
33.3%
6/18 • Number of events 6 • 24 months
|
22.2%
4/18 • Number of events 4 • 24 months
|
Other adverse events
| Measure |
Insulin Treatment for Hyperglycemia
n=18 participants at risk
NPH Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG \> 240, NPH initiation: 14, dose increases by 4; For pts. with CPG \> 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG \> 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG \> 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-\<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-\<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG \<60 mg/dl, NPH initiation: 0, ½ of previous dose.
|
Standard of Care
n=18 participants at risk
Patients assigned in this arm will receive standard of care following their kidney transplantation.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
38.9%
7/18 • Number of events 7 • 24 months
|
16.7%
3/18 • Number of events 3 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
8/18 • Number of events 8 • 24 months
|
33.3%
6/18 • Number of events 6 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
72.2%
13/18 • Number of events 13 • 24 months
|
55.6%
10/18 • Number of events 10 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
6/18 • Number of events 6 • 24 months
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Cardiac disorders
Hypertension
|
16.7%
3/18 • Number of events 3 • 24 months
|
38.9%
7/18 • Number of events 7 • 24 months
|
|
Endocrine disorders
Low Vitamin D
|
16.7%
3/18 • Number of events 3 • 24 months
|
50.0%
9/18 • Number of events 9 • 24 months
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
44.4%
8/18 • Number of events 8 • 24 months
|
38.9%
7/18 • Number of events 7 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place