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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Type II Diabetes

Treatments: Drug: Insulin; Drug: Metformin; Drug: Farxiga; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02429258

D1690L00026

Details and patient eligibility

About

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

Full description

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

Enrollment: 226 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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226 participants in 2 patient groups, including a placebo group

Farxiga with metformin or insulin

Experimental group

Description:

Farxiga with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications

Treatment:

Drug: Farxiga

Drug: Insulin

Drug: Metformin

Placebo with metformin or insulin

Placebo Comparator group

Description:

Placebo with metformin (\>/=1500mg/day) or insulin (\>/=30 units/day) and up to 2 OAD medications

Treatment:

Drug: Placebo

Drug: Insulin

Drug: Metformin