Phase 3
N=127
Vitamin D for Established Type 2 Diabetes (DDM2)
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01736865 ↗Enrolled (actual)
127
Serious AEs
10.2%
Results posted
Jan 2019
Primary outcome: Primary: Disposition Index — 0.023; 0.149 index
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cholecalciferol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disposition Index |
0.023; 0.149 | — |
| SECONDARY Number of Participants With Change in Glycemia |
53; 52 | — |
Summary
This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).
Eligibility Criteria
Inclusion Criteria
- Established type 2 diabetes, defined by one of the following two criteria:
- Age ≥ 25 years and ≤ 75 years
- BMI: 23 to 40 kg/m2 inclusive
- Provision of signed and dated written informed consent prior to any study procedures.
Major Exclusion Criteria
- "Severe" diabetes defined by one of the following criteria:
- - (a) Symptoms of hyperglycemia;
- - (b) Screening HbA1c ≥ 7.5 [may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy]
- History of nephrolithiasis or hypercalcemia
Data sourced from ClinicalTrials.gov (NCT01736865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.