BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)

Key facts

Study ID

NCT01498185

Run by

AstraZeneca

People needed

171

Starts

2012-02-01

Expected to finish

2012-10-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Profil Institute For Clinical Research, Inc. — Chula Vista, California, United States
• Va San Diego Healthcare System — San Diego, California, United States
• La Biomed Research Inst. At Harbor Ucla Med Ctr. — Torrance, California, United States
• Compass Research Phase 1, Llc — Orlando, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Vince And Associates Clinical Research — Overland Park, Kansas, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• Louisiana Research Associates, Inc. — New Orleans, Louisiana, United States
• Jasper Clinic, Inc. — Kalamazoo, Michigan, United States
• Kansas City University Of Medicine And Biosciences — Kansas City, Missouri, United States
• Regional Medical Clinic-Endocrinology — Rapid City, South Dakota, United States
• Dallas Diabetes & Endocrine Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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