Phase 4
Completed N=63
An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Source: ClinicalTrials.gov NCT03267576 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1 — -0.69; 0.24 Percentage of CV
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV), expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1 |
-0.69; 0.24 | — |
| PRIMARY Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2 |
-1.26; 0.77 | — |
| SECONDARY Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile |
-7.64; -8.40; -8.53; -7.13 | — |
| SECONDARY Change From Baseline in Mean 24-hour Glucose Profile |
-34.81; -39.56; -31.27; -41.74 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose Levels |
-32.04; -34.48; -27.69; -45.51 | — |
| SECONDARY Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels |
-47.03; -43.36; -41.12; -44.03 | — |
| SECONDARY Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL |
0.157; 0.191; 0.192; 0.182 | — |
| SECONDARY Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL |
-0.161; -0.216; -214; -0.221 | — |
| SECONDARY Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL |
-0.235; -0.212; -0.246; -0.251 | — |
| SECONDARY Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL |
NA; NA; NA; NA | — |
| SECONDARY Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL |
226.64; 275.64; 277.00; 261.57 | — |
| SECONDARY Change From Baseline in Time Spent With Glucose Level > 140 mg/dL |
-231.98; -310.41; -308.68; 318.23 | — |
| SECONDARY Change From Baseline in Time Spent With Glucose Level > 180 mg/dL |
-338.36; -305.69; -354.63; -361.65 | — |
| SECONDARY Change From Baseline in Time Spent With Glucose Level < 70 mg/dL |
NA; NA; NA; NA | — |
| SECONDARY Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL |
NA; NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Inadequate glucose control while using metformin monotherapy (MET) for at least 8 weeks at stable daily doses of at least 1500 milligram (mg) before screening visit (Visit 1)
a. Hemoglobin A1c (HbA1c) equal to (=) 7.5 percent (%) to 10.5% at Visit 1
- Adequate qualifying continuous glucose monitoring (CGM) reading during the pre-randomization (selection) phase
- Estimated glomerular filtration rate (eGFR) of at least 60 milliliter/minute (mL/min)/1.73 meter square (m^2) at Visit 1
- Body mass index of 22 through 45 kilogram per meter square (kg/m^2) at Visit 1
Exclusion Criteria
- History of any of the following (at Visit 1):
- Diabetic ketoacidosis (DKA)
- Type 1 diabetes mellitus (T1DM)
- Pancreatic (for example, Beta-islet cell) transplantation
- Diabetes secondary to pancreatitis or pancreatectomy
- Personal history of, or ongoing, pancreatitis
- One or more episodes of severe hypoglycemia (requiring assistance from others), as documented in the history obtained at Visit 1
- Hereditary glucose-galactose malabsorption or primary renal glucosuria
- Repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose (SMBG) greater than (>) 270 milligram per deciliter (mg/dL) during the pre-treatment phase
- Treatment with any other oral or parenteral antidiabetic medications different from metformin monotherapy, including but not limited to Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sulphonylureas, thiazolidinediones, insulins and Glucagon-like peptide-1 receptor agonist (GLP-1RAs); Sodium-glucose co-transporter 2 (SGLT-2) inhibitors and investigational agents
- Received an investigational drug or vaccine or used an invasive investigational medical device within 30 days before the planned first dose of study drug
- Current use of "natural medicines" or natural medicinal products for diabetes (for example, cactus-derived nutrients, celery)
Data sourced from ClinicalTrials.gov (NCT03267576). 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.