Phase 3
Completed N=4
A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00357370 ↗Enrolled (actual)
4
Serious AEs
2.8%
Results posted
May 2017
Primary outcomePrimary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 — 0.09; -0.61; -0.69 % of hemoglobin
◆ Published Evidence
Highly cited
361citations · ~21 / year
A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment.
Summary
The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.
Linked Publications (3)
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A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment.
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The effect of dapagliflozin on renal function in patients with type 2 diabetes.
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Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 |
0.09; -0.61; -0.69 | — |
| SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 |
17.80; 2.36; -9.64 | — |
| SECONDARY Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 |
1; 3; 1 | — |
| SECONDARY Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 |
0; 1; 0 | — |
| SECONDARY Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 |
3; 15; 15 | — |
| SECONDARY Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2 |
1.69; -1.35; -0.83 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
- Subjects receiving insulin and metformin and/or a thiazolidinedione
- Body Mass Index 2.5 times the upper limit of normal
- Creatinine kinase ≥3 times the upper limit of normal
- Symptoms of severely uncontrolled diabetes
- History of hypoglycemic unawareness
- Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Data sourced from ClinicalTrials.gov (NCT00357370) 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.