Trial Outcomes & Findings for Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life. (NCT NCT00624013)

NCT ID: NCT00624013

Last Updated: 2017-12-12

Results Overview

Change in HbA1C (%) at month 0 and month 6

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 89 participants
• Primary outcome timeframe: Month 0 and month 6
• Results posted on: 2017-12-12

Participant Flow

Patients were screened for depression using Whooley's two questions tool at a county diabetes clinic.

Participant milestones

Measure	Placebo Comparator:Placebo Placebo: 50 mg up to 100 mg daily for 6 months	Active Comparator: Sertraline sertraline: 50 mg up to 100 mg daily for 6 months
Overall Study STARTED	44	45
Overall Study COMPLETED	36	39
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eight subjects from placebo arm A dropped the study and six subjects from active comparator group B dropped from the study.

Baseline characteristics by cohort

Measure	Placebo Comparator: Placebo n=44 Participants Placebo: 50 mg up to 100 mg daily for 6 months	Active Comparator: Sertraline n=45 Participants sertraline: 50 mg up to 100 mg daily for 6 months	Total n=89 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 10 • n=36 Participants • Eight subjects from placebo arm A dropped the study and six subjects from active comparator group B dropped from the study.	52 years STANDARD_DEVIATION 8 • n=39 Participants • Eight subjects from placebo arm A dropped the study and six subjects from active comparator group B dropped from the study.	53 years STANDARD_DEVIATION 8 • n=75 Participants • Eight subjects from placebo arm A dropped the study and six subjects from active comparator group B dropped from the study.
Sex: Female, Male Female	32 Participants n=44 Participants	33 Participants n=45 Participants	65 Participants n=89 Participants
Sex: Female, Male Male	12 Participants n=44 Participants	12 Participants n=45 Participants	24 Participants n=89 Participants
Race/Ethnicity, Customized Hispanic	39 participants n=44 Participants	39 participants n=45 Participants	78 participants n=89 Participants
Race/Ethnicity, Customized African American	5 participants n=44 Participants	5 participants n=45 Participants	10 participants n=89 Participants
Region of Enrollment United States	44 participants n=44 Participants	45 participants n=45 Participants	89 participants n=89 Participants

PRIMARY outcome

Timeframe: Month 0 and month 6

Change in HbA1C (%) at month 0 and month 6

Outcome measures

Measure	Placebo n=36 Participants Placebo Comparator: 50 mg up to 100 mg daily for 6 months	Sertraline n=39 Participants sertraline: 50 mg up to 100 mg daily for 6 months
HbA1C (%) HbA1C (%) Month 0	9.7 Percentage of glycosylated hemoglobin Standard Deviation 1.6	10.0 Percentage of glycosylated hemoglobin Standard Deviation 1.8
HbA1C (%) HbA1C (%) Month 6	8.8 Percentage of glycosylated hemoglobin Standard Deviation 1.9	8.0 Percentage of glycosylated hemoglobin Standard Deviation 1.4

SECONDARY outcome

Timeframe: Month 0 and month 6

Quality of life (QOL) was assed at baseline and at month 6 using validated instrument Diabetes-39 Quality of Life Questionnaire. It consists of 39-item questionnaire designed to help us learn more about what affects the quality of life of people with diabetes in five dimensions of patients' lives: Diabetes Control, Anxiety and Worry, Social Burden, Sexual Functioning and Energy and Mobility. The Diabetes-39 questionnaire uses a Not Affected At All -Extremely Affected point scale score ranging from 1-7. Raw scale scores were transformed to a 0-100 scale using a linear transformation. Higher values represent a worse outcome. Overall rating of Quality-of-Life was assessed using a Lowest quality-Highest quality scale ranging from 1-7. Higher values represent an increase or improvement in overall QOL. Pattern of Diabetes Severity was measured with a Not Severe at all-Extremely Severe scale ranging from 1-7. Higher values represent increase in diabetes severity.

Outcome measures

Measure	Placebo n=36 Participants Placebo Comparator: 50 mg up to 100 mg daily for 6 months	Sertraline n=39 Participants sertraline: 50 mg up to 100 mg daily for 6 months
Quality of Life Overall Quality of Life at Month 0	3.0 units on a scale Standard Deviation 2	3.5 units on a scale Standard Deviation 3
Quality of Life Overall Quality of Life at month 6	4.0 units on a scale Standard Deviation 2	5.0 units on a scale Standard Deviation 3
Quality of Life Diabetes Severity at Month 0	6.0 units on a scale Standard Deviation 3	6.0 units on a scale Standard Deviation 3
Quality of Life Diabetes Severity at Month 6	5.0 units on a scale Standard Deviation 2	5.0 units on a scale Standard Deviation 2
Quality of Life Diabetes Control at Month 0	66.7 units on a scale Standard Deviation 18.6	69.6 units on a scale Standard Deviation 13.4
Quality of Life Diabetes Control at Month 6	55.7 units on a scale Standard Deviation 17.7	49.8 units on a scale Standard Deviation 22.0
Quality of Life Anxiety and Worry at Month 0	76.7 units on a scale Standard Deviation 16.5	78.8 units on a scale Standard Deviation 12.6
Quality of Life Anxiety and Worry at Month 6	61.9 units on a scale Standard Deviation 22.1	57.1 units on a scale Standard Deviation 21.8
Quality of Life Social Burden at Month 0	63.7 units on a scale Standard Deviation 25.2	68.2 units on a scale Standard Deviation 17.3
Quality of Life Social Burden at Month 6	50.4 units on a scale Standard Deviation 23.8	43.8 units on a scale Standard Deviation 25.8
Quality of Life Sexual Function at Month 0	66.6 units on a scale Standard Deviation 32.4	67.8 units on a scale Standard Deviation 28.2
Quality of Life Sexual Function at Month 6	61.1 units on a scale Standard Deviation 33.2	56.7 units on a scale Standard Deviation 31.2
Quality of Life Energy and Mobility at Month 0	63.1 units on a scale Standard Deviation 20.1	67.6 units on a scale Standard Deviation 16.2
Quality of Life Energy and Mobility at Month 6	49.7 units on a scale Standard Deviation 22.0	44.6 units on a scale Standard Deviation 21.1

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Sertraline

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=44 participants at risk Placebo Comparator: 50 mg up to 100 mg daily for 6 months	Sertraline n=45 participants at risk sertraline: 50 mg up to 100 mg daily for 6 months
Psychiatric disorders Suicidal ideation	2.3% 1/44 • Number of events 1 • 6 months	0.00% 0/45 • 6 months
Skin and subcutaneous tissue disorders skin rash	2.3% 1/44 • Number of events 1 • 6 months	0.00% 0/45 • 6 months

Other adverse events

Measure	Placebo n=44 participants at risk Placebo Comparator: 50 mg up to 100 mg daily for 6 months	Sertraline n=45 participants at risk sertraline: 50 mg up to 100 mg daily for 6 months
Social circumstances moved out of the country	2.3% 1/44 • Number of events 1 • 6 months	6.7% 3/45 • Number of events 3 • 6 months

Additional Information

Diana Echeverry, MD, Principal Investigator

Charles Drew University of Medicine and Science

Phone: 3235634800

Results disclosure agreements

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