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Trial Outcomes & Findings for Vitamin D for Established Type 2 Diabetes (DDM2) (NCT NCT01736865)

NCT ID: NCT01736865

Last Updated: 2020-04-01

Results Overview

Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

127 participants

Primary outcome timeframe

6 months

Results posted on

2020-04-01

Participant Flow

127 participants were enrolled because by the time the 124 "needed" was reached, 3 additional participants were eligible and wanted to be part of the trial.

Participant milestones

Participant milestones
Measure
Placebo
One placebo pill daily for 1 year Placebo
Cholecalciferol
One cholecalciferol pill daily for 1 year Cholecalciferol
Overall Study
STARTED
61
66
Overall Study
COMPLETED
61
66
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D for Established Type 2 Diabetes (DDM2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=61 Participants
One placebo pill daily for 1 year Placebo
Cholecalciferol
n=66 Participants
One cholecalciferol pill daily for 1 year Cholecalciferol
Total
n=127 Participants
Total of all reporting groups
Age, Continuous
60.3 years
STANDARD_DEVIATION 8.5 • n=93 Participants
60.1 years
STANDARD_DEVIATION 8.4 • n=4 Participants
60.2 years
STANDARD_DEVIATION 8.4 • n=27 Participants
Sex: Female, Male
Female
21 Participants
n=93 Participants
17 Participants
n=4 Participants
38 Participants
n=27 Participants
Sex: Female, Male
Male
40 Participants
n=93 Participants
49 Participants
n=4 Participants
89 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=93 Participants
2 Participants
n=4 Participants
3 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
60 Participants
n=93 Participants
60 Participants
n=4 Participants
120 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
4 Participants
n=4 Participants
4 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
2 Participants
n=93 Participants
4 Participants
n=4 Participants
6 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
21 Participants
n=93 Participants
17 Participants
n=4 Participants
38 Participants
n=27 Participants
Race (NIH/OMB)
White
38 Participants
n=93 Participants
41 Participants
n=4 Participants
79 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
4 Participants
n=4 Participants
4 Participants
n=27 Participants
Body Mass Index (BMI)
31.2 kg/ m2
STANDARD_DEVIATION 3.8 • n=93 Participants
30.7 kg/ m2
STANDARD_DEVIATION 3.9 • n=4 Participants
30.9 kg/ m2
STANDARD_DEVIATION 3.8 • n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels.

Outcome measures

Outcome measures
Measure
Placebo
n=59 Participants
One placebo pill daily for 1 year Placebo
Cholecalciferol
n=61 Participants
One cholecalciferol pill daily for 1 year Cholecalciferol
Disposition Index
0.023 index
Standard Error 0.057
0.149 index
Standard Error 0.056

SECONDARY outcome

Timeframe: 12 months

Change in glycemia (categorical variable, composite outcome) defined as \[1\] a decrease in diabetes medications or \[2\] a reduction of equal to or more than 0.4 HbA1c units from baseline without increasing medications.

Outcome measures

Outcome measures
Measure
Placebo
n=59 Participants
One placebo pill daily for 1 year Placebo
Cholecalciferol
n=61 Participants
One cholecalciferol pill daily for 1 year Cholecalciferol
Number of Participants With Change in Glycemia
53 Participants
52 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure
Placebo
n=59 Participants
One placebo pill daily for 1 year Placebo
Cholecalciferol
n=61 Participants
One cholecalciferol pill daily for 1 year Cholecalciferol
Hemoglobin A1c
0.2 percentage
Standard Error 0.07
0.2 percentage
Standard Error 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 and 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 months

Variability of response to vitamin D supplementation in subgroups defined by baseline characteristics: (1) race; (3) 25OHD concentration; (3) diabetes treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure
Placebo
n=61 Participants
One placebo pill daily for 1 year Placebo
Cholecalciferol
n=66 Participants
One cholecalciferol pill daily for 1 year Cholecalciferol
Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration
27.5 ng/mL
Standard Deviation 12.0
25.8 ng/mL
Standard Deviation 10.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 and 12 months

Cardiovascular risk factors defined as blood pressure, lipid profile, C-reactive protein and urine albumin excretion

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths

Cholecalciferol

Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo
n=61 participants at risk
One placebo pill daily for 1 year Placebo
Cholecalciferol
n=66 participants at risk
One cholecalciferol pill daily for 1 year Cholecalciferol
General disorders
New or prolonged hospitalization
9.8%
6/61 • Number of events 6 • 12 Months
10.6%
7/66 • Number of events 7 • 12 Months

Other adverse events

Other adverse events
Measure
Placebo
n=61 participants at risk
One placebo pill daily for 1 year Placebo
Cholecalciferol
n=66 participants at risk
One cholecalciferol pill daily for 1 year Cholecalciferol
General disorders
Adverse Event
39.3%
24/61 • Number of events 24 • 12 Months
25.8%
17/66 • Number of events 17 • 12 Months

Additional Information

Dr. Anastassios Pittas

Tufts Medical Center

Phone: 617-636-5694

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place