Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Study Overview
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Brief Summary
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Effect of Dapagliflozin on 24-hour Blood Glucose in Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Detailed Description
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Effect of Dapagliflozin on 24-hour Blood Glucose in 92 Type 2 Diabetes Patients Inadequately Controlled With Either Metformin Or Insulin

Official Title
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Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

Conditions
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Type II Diabetes

Intervention / Treatment
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* Drug: Farxiga
* Drug: Placebo
* Drug: Metformin
* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus (T2DM) Treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose of insulin > or = to 30 units/day and up to 2 OAD medications for at least 8 weeks Hemoglobin A1c (HbA1c) 7.5% to 10.5% at screening Body mass index (BMI) < or = to 45 kg/m2 Exclusion Criteria: For patients who enter the study taking a stable dose of metformin, history of taking OAD medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening For patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 OAD medications for 8 weeks prior to screening. Use of sulfonylureas during the 8 weeks prior to screening Prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (SGLT-2) inhibitor Ingestion of any medication know to affect glucose metabolism for >7 consecutive days during the 3 months prior to screening Ingestion of prescription or over the counter weight loss medication during 3 months prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Farxiga with metformin or insulin<br>Farxiga with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications | Drug: Farxiga<br>* Farxiga 10mg/day<br>Drug: Metformin<br>* Metformin background therapy >/= 1500mg/day<br>Drug: Insulin<br>* Insulin >/= 30 units<br>|
| Placebo Comparator: Placebo with metformin or insulin<br>Placebo with metformin (>/=1500mg/day) or insulin (>/=30 units/day) and up to 2 OAD medications | Drug: Placebo<br>* Placebo<br>Drug: Metformin<br>* Metformin background therapy >/= 1500mg/day<br>Drug: Insulin<br>* Insulin >/= 30 units<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System |  | Baseline to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4 |  | Baseline to Week 4 | 
| Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population |  | Baseline to Week 4 | 
| Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population |  | Baseline to Week 4 | 
| Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population |  | Baseline to Week 4 | 
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4 |  | Baseline to Week 4 | 
| Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4 |  | Baseline to Week 4 | 
| Change in HbA1c From Baseline to Week 4 |  | Baseline to Week 4 | 
| Change in Fructosamine From Baseline to Week 4 |  | Baseline to Week 4 | 
| Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4 |  | Baseline to Week 4 | 
| Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population |  | Baseline to Week 4 |