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

Type II Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429258
• Other study ID #: D1690L00026
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2015
• Last updated: December 22, 2015
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 2OAD 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Drug:
• Farxiga
Farxiga 10mg/day
• Placebo
Placebo
• Metformin
Metformin background therapy >/= 1500mg/day
• Insulin
Insulin >/= 30 units

Locations

Country	Name	City	State
United States	Research Site	Bartlett	Tennessee
United States	Research Site	Birmingham	Alabama
United States	Research Site	Brockton	Massachusetts
United States	Research Site	Brooklyn	New York
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cooper City	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Dublin	Ohio
United States	Research Site	Eugene	Oregon
United States	Research Site	Evanston	Illinois
United States	Research Site	Franklin	Ohio
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Henderson	Nebraska
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Park	California
United States	Research Site	Hurst	Texas
United States	Research Site	Lansdale	Pennsylvania
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Miami	Florida
United States	Research Site	Omaha	Nebraska
United States	Research Site	Oxon Hill	Maryland
United States	Research Site	Phoenix	Arizona
United States	Research Site	Renton	Washington
United States	Research Site	Rochester	New York
United States	Research Site	Sacramento	California
United States	Research Site	San Diego	California
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour mean weighted glucose	Change in 24-hour mean weighted glucose	Baseline to Week 4	No
Secondary	Change in the 24-hour mean amplitude of glucose excursion	Change in the 24-hour mean amplitude of glucose excursion (MAGE; "distance traveled" arc length of the curve; and "energy") using the CGM (continuous glucose monitoring) system	Baseline to Week 4	No
Secondary	Change in proportion of time patients had plasma glucose measurements <70 mg/dL, >/= 70 mg/dL and </= 180mg/dL, and >180mg/dL	Change in proportion of time patients had plasma glucose measurements < 70 mg/dL, >/= 70 mg/dL and	Baseline to Week 4	No
Secondary	Change in Fasting Plasma Glucose (FPG)	Change in FPG	Baseline to Week 4	No
Secondary	Change in 4-hour mean weighted postprandial glucose (PPG)	Change in 4-hour mean weighted PPG (after breakfast meal)	Baseline to Week 4	No
Secondary	Change in Hemoglobin A1c (HbA1c)	Change in HbA1c	Baseline to Week 4	No
Secondary	Change in fructosamine	Change in fructosamine	Baseline to Week 4	No
Secondary	Change in 2-hour mean weighted PPG	Change in 2-hour mean weighted PPG after the standardized breakfast meal	Baseline to Week 4	No
Secondary	Differences in 24-hour glucose profile	Difference in 24-hour glucose profile during 7-day continuous glucose monitoring (CGM) assessments	Baseline to Week 4	No
Secondary	Change in insulin secretion	Change in insulin secretion	Baseline to Week 4	No
Secondary	Change in insulin sensitivity	Change in insulin sensitivity	Baseline to Week 4	No