Type 2 Diabetes Mellitus
Conditions
Brief summary
This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.
Interventions
DRUGStandard Treatment
traditional drugs only
incretin-based drugs
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetics diagnosed for at least 6 months * Patients ages ≥ 65 years and older * Active patients in the Bay West Endocrinology practice * Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12% * Eligible for randomization to either treatment group * Patients willing to follow either treatment arm including regimen using one or more injectables * Patients to have an English Reading Level of Grade 6 or above * Patients residing at home
Exclusion criteria
* Unwilling to use a regimen that may contain using one or more injections * Using short acting insulin prior to the study * Using GLP-1 in past 10 weeks * History of hypoglycemia unawareness or episodes needing emergency intervention * End-stage renal disease * Dementia * Blindness * Terminal illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Glycemic Target (HbA1c <7.5%). | 6 months | Data not analyzed due to n=1 each arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Hypoglycemia Measured by Glucose Meter | 6 months | Data not analyzed due to n=1 each arm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Quality of Life | 6 months | Data not analyzed due to n=1 each arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment A regimen with traditional drugs only
Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only | 1 |
| Incretin-based Treatment A regimen including incretin-based drugs
Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | n=1 each arm | 1 | 1 |
Baseline characteristics
| Characteristic | Standard Treatment | Incretin-based Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 78 years | 67 years | 72.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Time to Achieve Glycemic Target (HbA1c <7.5%).
Data not analyzed due to n=1 each arm.
Time frame: 6 months
Population: Data not analyzed due to n=1 each arm.
Secondary
Overall Hypoglycemia Measured by Glucose Meter
Data not analyzed due to n=1 each arm.
Time frame: 6 months
Population: Data not analyzed due to n=1 each arm.
Other Pre-specified
Diabetes Quality of Life
Data not analyzed due to n=1 each arm
Time frame: 6 months
Population: Data not analyzed due to n=1 each arm