Dapagliflozin DPPIV Inhibitor add-on Study

Study Overview
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Brief Summary
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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.

Official Title
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A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Dapagliflozin 10 mg tablet | Drug: Dapagliflozin<br>* 10 mg tablet, oral, once daily, 48 weeks<br>|
| Placebo Comparator: 2<br>Matching placebo tablet | Drug: Placebo<br>* Matching placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in HbA1c Levels | To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin. | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in Body Weight | To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24. | Baseline to Week 24 | 
| Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8% | To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24. | Baseline to Week 24 | 
| Adjusted Mean Change in Fasting Plasma Glucose (FPG) | To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24. | Baseline to Week 24 | 
| Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg | To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8. | Baseline to Week 8 | 
| Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise | To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24. | Baseline to Week 24 | 
| Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline | To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value. | Baseline to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dapagliflozin DPP IV inhibitor add on study, Inadequate control