Trial Outcomes & Findings for Multifactorial Treatment of Cardiovascular Risk in Diabetic Patients: Identification of Treatment Non-Responders (NCT NCT00660790)
NCT ID: NCT00660790
Last Updated: 2021-03-19
Results Overview
Change of IMT from Baseline to 24 months
Recruitment status
COMPLETED
Target enrollment
97 participants
Primary outcome timeframe
24 months (from Baseline Visit to Visit 24 months after Baseline)
Results posted on
2021-03-19
Participant Flow
Participants were recruited from the outpatient clinic from the University Hospital of Graz.
111 subjects were screened for the study between April 2008 and May 2010. Study inclusion criteria were met by 97 patients who were enrolled in the study.
Participant milestones
| Measure |
Patients With Type 2 Diabetes
diabetic subjects, above targets
Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines
|
|---|---|
|
Baseline to 3 Months
STARTED
|
97
|
|
Baseline to 3 Months
COMPLETED
|
94
|
|
Baseline to 3 Months
NOT COMPLETED
|
3
|
|
3 Months to 2 Years
STARTED
|
94
|
|
3 Months to 2 Years
COMPLETED
|
77
|
|
3 Months to 2 Years
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Patients With Type 2 Diabetes
diabetic subjects, above targets
Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines
|
|---|---|
|
Baseline to 3 Months
Death
|
1
|
|
Baseline to 3 Months
Withdrawal by Subject
|
2
|
|
3 Months to 2 Years
Withdrawal by Subject
|
17
|
Baseline Characteristics
Multifactorial Treatment of Cardiovascular Risk in Diabetic Patients: Identification of Treatment Non-Responders
Baseline characteristics by cohort
| Measure |
Patients With Type 2 Diabetes
n=97 Participants
patients with type 2 diabetes
Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines
|
|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight
|
91 kg
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Blood Pressure systolic
|
154 mmHg
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Blood Pressure diastolic
|
90 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
|
HbA1c (glycated hemoglobin)
|
66 mmol/mol
STANDARD_DEVIATION 12 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 months (from Baseline Visit to Visit 24 months after Baseline)Change of IMT from Baseline to 24 months
Outcome measures
| Measure |
Patients With Type 2 Diabetes
n=77 Participants
diabetic subjects, above targets
Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines
|
|---|---|
|
Change of Intima Media Thickness (IMT)
|
-0.023 mm
Standard Deviation 0.010
|
Adverse Events
Patients With Type 2 Diabetes
Serious events: 18 serious events
Other events: 35 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Patients With Type 2 Diabetes
n=97 participants at risk
diabetic subjects, above targets
Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines
|
|---|---|
|
Vascular disorders
Insult
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Surgical and medical procedures
Gall bladder removal
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Renal and urinary disorders
Kidney cyst
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Metabolism and nutrition disorders
switch to insulin therapy
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Cardiac disorders
Cardiac insufficiency
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Cardiac disorders
Insertion of stents
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Gastrointestinal disorders
Adenoma
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Eye disorders
eye surgery
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Surgical and medical procedures
Spinal canal surgery
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Renal and urinary disorders
Kidney tumor
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Surgical and medical procedures
Tenodvaginitis stenosans
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Gastrointestinal disorders
chronic gastritis
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Vascular disorders
diabetic arterial disease
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Vascular disorders
Endarterectomy
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Surgical and medical procedures
Umbilical hernia
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Gastrointestinal disorders
prepyloric ulcera
|
1.0%
1/97 • Number of events 1 • Adverse events were collected from Baseline to study end (after 2 years).
|
Other adverse events
| Measure |
Patients With Type 2 Diabetes
n=97 participants at risk
diabetic subjects, above targets
Intensified Treatment of risk factors: Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines
|
|---|---|
|
Metabolism and nutrition disorders
Hypoglycaemic Event
|
7.2%
7/97 • Number of events 16 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
General disorders
Nausea
|
20.6%
20/97 • Number of events 30 • Adverse events were collected from Baseline to study end (after 2 years).
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
8.2%
8/97 • Number of events 10 • Adverse events were collected from Baseline to study end (after 2 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place