Phase 3
Completed N=451
Dapagliflozin DPPIV Inhibitor add-on Study
Source: ClinicalTrials.gov NCT00984867 ↗Enrolled (actual)
451
Serious AEs
4.2%
Results posted
Oct 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — 0.04; -0.45 Percent — p=<0.0001
Summary
This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
0.04; -0.45 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Body Weight |
-0.26; -2.14 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8% |
0.03; -0.80 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Fasting Plasma Glucose (FPG) |
3.81; -24.11 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg |
-5.12; -5.98 | 0.5583 |
| SECONDARY Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise |
-6.84; -21.65 | — |
| SECONDARY Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline |
16.6; 35.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes
- Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
- Patients will be screened by a blood test and only those who need additional therapy can be enrolled
Exclusion Criteria
- Patients with type 1 diabetes
- Patients with very poorly controlled diabetes
- Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
Data sourced from ClinicalTrials.gov (NCT00984867). 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.