Phase 4
Completed N=29
Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes
Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02964585 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression) — 0.63; 0.33; 1.58; 0.90 ng/mL in serum
◆ Published Evidence
Established
53citations · ~11 / year
Role of Canagliflozin on function of CD34+ve endothelial progenitor cells (EPC) in patients with type 2 diabetes.
Summary
The investigators hypothesize that Cana may be able to improve number and function of CD34+ endothelial progenitor cells. The investigators also propose that this expected cardiovascular benefit is independent of HbA1C reduction.
Subjects will begin taking 100 mg of Cana or placebo after initial 4 weeks. Subjects will be withdrawn from the study if the medication or placebo is not tolerated.
Linked Publications
-
Role of Canagliflozin on function of CD34+ve endothelial progenitor cells (EPC) in patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Protein Expression) |
0.63; 0.33; 1.58; 0.90; 2.10; 1.03 | — |
| PRIMARY Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Percentages) |
0.93; 1.23; 2.58; 2.16; 0.37; 0.61 | — |
| PRIMARY Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Counts) |
155.09; 155.09; 2682.93; 3157.36 | — |
| PRIMARY Gene Expression and Function Change of CD34+ Endothelial Progenitor Cells (Cell Proliferation) |
7.53; 13.69 | — |
| SECONDARY Serum Endothelial Inflammatory Markers (1) |
4.56; 3.21; 1.36; 1.63 | — |
| SECONDARY Fasting Lipid Profile |
171.57; 147.76; 46.17; 51.67; 96.03; 82.672 | — |
| SECONDARY Glycemic Control (HbA1C) |
7.85; 8.26 | — |
| SECONDARY BMI |
30.53; 34.64 | — |
| SECONDARY Resting Metabolic Rate (RMR) |
1999.31; 1863.01 | — |
| SECONDARY Pulse Wave Velocity |
10.12; 11.42 | — |
| SECONDARY Serum Endothelial Inflammatory Markers (2) |
0.63; 0.92 | — |
| SECONDARY Glycemic Control |
142.79; 158.0 | — |
| SECONDARY Body Fat Percentage |
32.46; 38.58 | — |
| SECONDARY Augmentation Index (Pulse Wave Analysis) |
28.67; 21.37 | — |
| SECONDARY Kidney Function Markers |
6.62; 6.68; 5.24; 5.87; 5.75; 6.36 | — |
| SECONDARY Creatinine (Urine) |
77.08; 106.23 | — |
| SECONDARY Microalbumin |
33.97; 43.41 | — |
| SECONDARY eGFR |
79.90; 88.33 | — |
Eligibility Criteria
Inclusion Criteria
- Age 30-70 years
- Currently treated with any combination of the following anti-diabetic therapies: metformin (1-2 grams), insulin, GLP-1 agonists, a DPP-IV inhibitor, or sulfonylureas
- Hemoglobin A1C (HbA1C) between 7.0% and 10.0%
- Body Mass Index (BMI) between 25 and 39.9 kg/m^2 (both inclusive)
Exclusion Criteria
- Type 1 diabetes
- History of hyperosmolar nonketotic coma
- History of diabetic ketoacidosis in the last 3 months
- Abnormal CBC that is judged by physician to be unsafe to enroll or low hematocrit ( 150 mmHg and diastolic Blood Pressure > 90 mmHg
- Active wounds or recent surgery within 3 months
- Untreated hyper/hypothyroidism
Physical and Laboratory Test Findings:
- Pre-existing liver disease and/or ALT and AST >2.5X's UNL
- Serum creatinine levels ≥2.0
- Estimated CrCl 450 mg/dL
Allergies and Adverse Drug Reactions:
- Subjects with a history of any serious hypersensitivity reaction to Cana or another SGLT2 inhibitor.
Sex and Reproductive Status:
- Women in reproductive age group will be included in the study but encouraged to use contraceptive method to avoid pregnancy within 16 weeks of study duration.
- Women who are pregnant or breast-feeding will be excluded.
Other Exclusion Criteria:
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
- Patients who are active smokers
- Patients who are pregnant
- Nursing women
- Post-menopausal women who are on estrogen hormone replacement therapy will be excluded.
- Patients on low dose oral contraceptives will be allowed to participate as these formulations contain very low amounts of estrogens.
- Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.
Data sourced from ClinicalTrials.gov (NCT02964585) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.