Phase 2
Completed N=351
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02139943 ↗
Enrolled (actual)
351
Serious AEs
4.8%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight — 14.5; 36.9; 41.4; 85.5 percentage of participants
Summary
The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight |
14.5; 36.9; 41.4; 85.5; 63.1; 58.6 | — |
| PRIMARY Percentage of Participants With Adverse Events |
54.7; 55.6; 67.5 | — |
Eligibility Criteria
Inclusion Criteria
- Must have type 1 diabetes mellitus (T1DM) for at least 1 year
- Must have have inadequate glycemic control (as defined by glycosylated hemoglobin level of >= 7.0% to = 0.6 IU/kg at screening
- Must be on a stable insulin regimen for at least 8 weeks prior to screening
Exclusion Criteria
- History of T2DM, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Severe hypoglycemia (defined as an event required assistance from another person, or which resulted in seizure or loss of consciousness) within 6 months prior to study start
- Diabetic ketoacidosis within 6 months prior to study start
- History of hereditary glucose-galactose malabsorption or primary renal glycosuria
- An ongoing, inadequately controlled thyroid disorder
Data sourced from ClinicalTrials.gov (NCT02139943). 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.