Type 2 Diabetes Mellitus
Conditions
Keywords
sitagliptin, type 2 diabetes, combination therapy
Brief summary
This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.
Detailed description
The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.
Interventions
DRUGSitagliptin
Sitagliptin 100 mg by mouth once daily
Sponsors
National Center for Research Resources (NCRR)
Charles Drew University of Medicine and Science
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, age 18-75 * Type 2 diabetes * At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) \>7.0%) * Able to comply with all scheduled visits and requirements of the protocol
Exclusion criteria
* Any contraindications to the use of metformin or a sulfonylurea agent * Extreme hyperglycemia or symptoms of polyuria or polydipsia * Current or previous chronic use of insulin (other than for treatment of gestational diabetes) * History of confirmed (or clinical suspicion of) type 1 diabetes mellitus * Episodes of symptomatic hypoglycemia averaging greater than once per day * Estimated glomerular filtration rate (eGFR) \< 60 mL/min * Subjects with active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c unreliable * History of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult. * Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception * Current pregnancy or lactation. * Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study. * Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry * Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c (HbA1c) Change From Baseline | Baseline, 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months | 4 months |
| Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year | 1 year |
| Number of Adverse Events | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sitagliptin Treatment Sitagliptin 100 mg once daily | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | Sitagliptin Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 104 Participants |
| Age, Continuous | 50.7 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 108 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 108 |
| serious Total, serious adverse events | 0 / 108 |
Outcome results
Primary
Hemoglobin A1c (HbA1c) Change From Baseline
Time frame: Baseline, 4 months
Population: Last Observation Carried Forward for subjects with paradoxical worsening of control (switched to alternate treatment before 4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin | Hemoglobin A1c (HbA1c) Change From Baseline | -1.3 percentage | Standard Deviation 1.8 |
Secondary
Number of Adverse Events
Time frame: 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sitagliptin | Number of Adverse Events | Hypoglycemia | 3 Adverse event |
| Sitagliptin | Number of Adverse Events | Other adverse events | 3 Adverse event |
Secondary
Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year | 26 participants |
Secondary
Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months
Time frame: 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sitagliptin | Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months | 47 participants |