Clinical trial NCT02429258: Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
Official title: Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type II Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population
timeFrame: Baseline to Week 4
measure: 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
timeFrame: Baseline to Week 4
measure: Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population
timeFrame: Baseline to Week 4
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in HbA1c From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in Fructosamine From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Huntington Park
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: West Hills
country: United States
facility: Research Site
state: California
city: Cooper City
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Evanston
country: United States
facility: Research Site
state: Illinois
city: Oxon Hill
country: United States
facility: Research Site
state: Maryland
city: Henderson
country: United States
facility: Research Site
state: Nebraska
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Dublin
country: United States
facility: Research Site
state: Ohio
city: Franklin
country: United States
facility: Research Site
state: Ohio
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Lansdale
country: United States
facility: Research Site
state: Pennsylvania
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Bartlett
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Hurst
country: United States
facility: Research Site
state: Texas
city: Renton
country: United States
facility: Research Site
state: Washington
Study officials:
References:
citation: Henry RR, Strange P, Zhou R, Pettus J, Shi L, Zhuplatov SB, Mansfield T, Klein D, Katz A. Effects of Dapagliflozin on 24-Hour Glycemic Control in Patients with Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Nov;20(11):715-724. doi: 10.1089/dia.2018.0052. Epub 2018 Sep 14.