Status:
COMPLETED
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.
Detailed Description
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
Eligibility Criteria
Inclusion
- Diagnosis of Type 1 Diabetes mellitus (T1DM)
- Central laboratory C-peptide \< 0.7 ng/ml (0.23 nmol/L)
- Insulin use for at least 12 months per patient reported or medical records
- Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
- Subjects must be on a total insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to screening
- If on MDI insulin administration, subject must be on ≥ 3x injections per day
- Screening Visit: Central laboratory HbA1c ≥ 7.7% and ≤ 11.0%
- Body mass index (BMI) ≥ 18.5 kg/m2
Exclusion
- History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
- Taking metformin and/or thiazolidinediones within 2 months prior to screening
- Taking any antidiabetic medication (other than insulin), within 1 month prior to screening
- \- Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
- History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
- History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
- Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
- History of Addison's disease
Key Trial Info
Start Date :
November 11 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2017
Estimated Enrollment :
833 Patients enrolled
Trial Details
Trial ID
NCT02268214
Start Date
November 11 2014
End Date
August 25 2017
Last Update
September 13 2018
Active Locations (131)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Little Rock, Arkansas, United States, 72205
2
Research Site
Encino, California, United States, 91436
3
Research Site
La Mesa, California, United States, 91942
4
Research Site
San Diego, California, United States, 92161