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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02429258
Other study ID # D1690L00026
Secondary ID
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


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
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