Phase 3
Completed N=1,692
Multi-arm Intervention Diabetes Adherence Study
Source: ClinicalTrials.gov NCT00754741 ↗Enrolled (actual)
1,692
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Glycated Hemoglobin Levels — 7.88; 7.91; 7.79 Percent — p=0.763
Summary
The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycated Hemoglobin Levels |
7.94; 7.96; 7.84 | 0.829 |
| PRIMARY LDL-cholesterol Levels |
89.02; 87.27; 85.56 | 0.380 |
| SECONDARY Adherence to Oral Anti-diabetic Medications |
0.75; 0.73; 0.73 | 0.469 |
| SECONDARY Adherence to Lipid-lowering Drugs |
0.70; 0.70; 0.70 | 0.952 |
| SECONDARY Cardiovascular Morbidity and Mortality (Exploratory) |
101; 112; 99 | 0.419 |
| SECONDARY Glycated Hemoglobin Levels |
7.94; 7.96; 7.84 | 0.829 |
| SECONDARY LDL Cholesterol Levels |
90.63; 90.70; 87.43 | 0.971 |
Eligibility Criteria
Inclusion Criteria
- At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month.
- At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months.
- Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d
- Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that include both medical and pharmacy coverage.
Exclusion Criteria
- Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period.
- Participation in a disease management program
Data sourced from ClinicalTrials.gov (NCT00754741). 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. Informational only — not medical advice.