Trial Outcomes & Findings for Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes (NCT NCT00409240)
NCT ID: NCT00409240
Last Updated: 2014-04-11
Results Overview
Hemoglobin A1C target was \< 7% LDL cholesterol goal of \< 100mg/dl or \<70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of \<130mm Hg
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
6 months
Results posted on
2014-04-11
Participant Flow
Veterans of the Providence VA Medical Center were eligible for the study. Dates of recruitment period were 2007-2009.
Participant milestones
| Measure |
MEDIC Intervention
Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
|
Usual Care
Patient continued on usual care
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
|
Overall Study
COMPLETED
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
MEDIC Intervention
n=50 Participants
Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
|
Usual Care
n=49 Participants
Patient continued on usual care
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
67.2 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
68.5 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
49 participants
n=107 Participants
|
99 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsHemoglobin A1C target was \< 7% LDL cholesterol goal of \< 100mg/dl or \<70mg/dl for patients at high risk-current cardiovascular disease Systolic blood pressure goal of \<130mm Hg
Outcome measures
| Measure |
MEDIC Intervention
n=50 Participants
Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
|
Usual Care
n=49 Participants
Patient continued on usual care
|
|---|---|---|
|
Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
Percentage achieving A1C of <7%
|
40.8 participants
|
20.4 participants
|
|
Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
Percentage achieving LDL at goal
|
82.0 participants
|
65.3 participants
|
|
Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
Percentage achieving systolic Blood Pressure < 130
|
58.0 participants
|
32.7 participants
|
|
Percent of Patients Achieving Hemoglobin A1C Goal, LDL Cholesterol Goal, and Systolic Blood Pressure Goal From the Enrollment Until the End of the Study
Percentage Achieving combined goal A1c, SBP, LDL
|
16.0 participants
|
4.1 participants
|
Adverse Events
MEDIC Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MEDIC Intervention
n=50 participants at risk
Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction
MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
|
Usual Care
n=49 participants at risk
Patient continued on usual care
|
|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/50 • The time frame for adverse event reporting was the entire duration of the study.
|
2.0%
1/49 • The time frame for adverse event reporting was the entire duration of the study.
|
|
Endocrine disorders
Hypoglycemia
|
4.0%
2/50 • The time frame for adverse event reporting was the entire duration of the study.
|
0.00%
0/49 • The time frame for adverse event reporting was the entire duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung cancer surgery
|
0.00%
0/50 • The time frame for adverse event reporting was the entire duration of the study.
|
2.0%
1/49 • The time frame for adverse event reporting was the entire duration of the study.
|
|
General disorders
|
0.00%
0/50 • The time frame for adverse event reporting was the entire duration of the study.
|
2.0%
1/49 • The time frame for adverse event reporting was the entire duration of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place