Active, not recruitingPhase 4Interventional
What this study is about
Minorities have higher rates of diabetes, poorer glucose control, and higher complications and mortality rates than white people. Several recently approved diabetes medicines improve cardiovascular and renal outcomes through two different mechanisms. This study will explore key determinants of blood glucose levels namely beta cell function after short-term randomized, parallel group treatment with FDA approved Glucagon-Like Peptide-1 Receptor Agonists¬ (GLP-1 RA), or FDA approved Sodium-Glucose co-Transporter-2 Inhibitor (SGLT-2i). Because diabetes in black people shows a unique ability to recover pancreatic insulin secretion, it is important to determine whether the effects of these drug classes differentially improve pancreatic beta cell function.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age24 Years to 80 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes (T2DM)
Full registry criteria
Inclusion Criteria: 1. Agrees to participate (signs and dates the informed consent) and agrees to all study procedures and conditions of the protocol. 2. Black (self-identified) patients with relatively recent onset (\< 15 years) DM2 3. aged \>= 24 years of age (adults \< age 24 years old need additional resources to consistently participate, and may have different metabolism) 4. HbA1c between 6.9% and 10%, inclusive 5. BMI \> 23 and \< 45 kg/m2, and stable body weight over 2 months 6. In good general health, as evidenced by medical history and physical examination. And not having any of the specific items of the exclusion criteria. 7. Currently taking no diabetes medication or on stable doses (2 months) of metformin or metformin plus sulfonylureas without additional diabetes medication(s). 8. Ability to take and agree to taking oral medication and to self-inject 9. For persons of reproductive potential: negative pregnancy test, use of effective contraception for at least 1 month prior to screening, and agreement to use such a method during study participation, and for an additional 4 weeks after completing the use of the study drug. They will be counseled that if they wish to become pregnant, they should follow the standard practice of optimizing their blood glucose in preparation for pregnancy. Use of these study drugs are not considered standard of care for diabetes during pregnancy. Effective contraception includes tubal ligation, hysterectomy, oral, implanted or injected contraceptives, mechanical (IUD) and barriers (diaphragm, condoms, spermicides) methods. 10. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout the study, including following a diabetic diet and maintaining a physical activity program Exclusion Criteria: 1. Poor general health, low kidney function (eGFR \< 45), abnormal liver blood tests (AST and ALT \> 3 times the ULN, Bilirubin 2 x ULN), serious cardiovascular, liver or renal disease, known proliferative retinopathy, type 1 diabetes, pancreatitis or pancreas cancer, medullary thyroid cancer, MEN2 (or family history of MEN2), current low hematocrit (\< 35% for men and 33% for women, frailty, at risk for falls, current (past six months) alcohol or substance use disorder, history of a non-traumatic bone fracture, amputation, organ transplant, HIV or COVID, or if the patient cannot complete study activities. 2. Current regular use of DDP-4 inhibitors, insulin or GLP-1 RA or SGLT2-inhibitors 3. Currently pregnant, planned pregnancy in the next 7 months or nursing/lactating. 4. Known allergic reactions to either the study medication 5. Treatment with another investigational drug or other intervention within 4 months, or plan to enroll in another interventional study during their participation in this study 6. Planned major surgery 7. Recent (within 6 months): MI, Stroke, Cerebrovascular accident or unstable angina or revascularization procedures, grade 3 or 4 heart failure 8. Use of weight loss medication, weight loss surgery. 9. Use of glucocorticoids for chronic illness within 8 weeks prior to screening or likely to begin glucocorticoids during study period 10. Study doctor considers subject a poor study candidate 11. Cancer - History of active or untreated malignancy or in remission from a clinically significant malignancy for \< 5 years; exception: basal cell carcinoma of the skin.
Primary outcomes
Change in Stimulated C-peptide Index during an Oral Glucose Tolerance Test is a measure of Beta Cell Function and will be measuresd at baseline and at 16 weeks after treatment with GLP-1 Receptor Agonist or SGLT2-InhibitorBaseline, 16 weeksPrimary Outcome Measure: The stimulated c-peptide index a primary outcome measure and is measured at baseline and 16 weeks. Change in the stimulated c-peptide index is the 16 week value minus the baseline. Higher numbers of the c-peptide index indicate better beta cell function while lower numbers indicated worse beta cell function. The stimulated c-peptide index is a calculated ratio of the c-peptide (ng/ml) to glucose levels (mg/dl) used to assess pancreatic beta cell function. It is calculated as the incremental area under the curve (AUC) of plasma C-peptide divided by the incremental AUC of plasma glucose (∆C-peptide 0-120/∆ Glucose 0-120). The outcome measure of plasma c-peptide (ng/ml) and plasma glucose (mg/dl), during the OGTT (after an overnight fast) at -15, 0, 10, 30, 45, 60, 90 and 120 minutes are combined into one primary outcome variable.
