Status:
COMPLETED
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Astra Zeneca, Bristol-Myers Squibb
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)
Detailed Description
Study Classification : Safety, Pharmacokinetics and Pharmacodynamics
Eligibility Criteria
Inclusion
- Type 1 diabetes with central lab Glycosylated hemoglobin (A1C) ≥ 7.0% and ≤ 10.0%
- Insulin use for at least 12 months and initiation immediately after diagnosis of diabetes
- Method of Insulin administration \[multiple daily injections (MDI) or continuous subcutaneous Insulin infusion (CSII)\] stable ≥ 3 months
- Stable basal Insulin dose ≥ 2 weeks
- Ages 18 to 65 years
- Central laboratory C-peptide value of \< 0.7 ng/mL
- Body mass index (BMI) 18.5 to 35.0 kg/m2
Exclusion
- History of type 2 diabetes mellitus (T2DM), maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis
- Oral hypoglycemic agents
- History of diabetes ketoacidosis (DKA) within 24 weeks
- History of hospital admission for glycemic control within 6 months
- Frequent episodes of hypoglycemia (2 unexplained within 3 months) or hypoglycemic unawareness
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or Serum total bilirubin \> 2X Upper limit of normal (ULN)
- Abnormal Free T4 \[if screening Thyroid Stimulating Hormone (TSH) abnormal\]
- Estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease (MDRD) formula ≤ 60 mL/min/1.73m2
- Cardiovascular (CV)/Vascular Diseases within 6 months
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT01498185
Start Date
February 1 2012
End Date
October 1 2012
Last Update
February 10 2017
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Profil Institute For Clinical Research, Inc.
Chula Vista, California, United States, 91911
2
Va San Diego Healthcare System
San Diego, California, United States, 92161
3
La Biomed Research Inst. At Harbor Ucla Med Ctr.
Torrance, California, United States, 90502
4
Compass Research Phase 1, Llc
Orlando, Florida, United States, 32806