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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Placebo matching Dapagliflozin; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01498185

MB102-072

Details and patient eligibility

About

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

Full description

Study Classification : Safety, Pharmacokinetics and Pharmacodynamics

Enrollment: 171 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

171 participants in 5 patient groups

Arm 1: Dapagliflozin (1 mg)

Experimental group

Treatment:

Drug: Dapagliflozin

Arm 2: Dapagliflozin (2.5 mg)

Experimental group

Treatment:

Drug: Dapagliflozin

Arm 3: Dapagliflozin (5 mg)

Experimental group

Treatment:

Drug: Dapagliflozin

Arm 4: Dapagliflozin (10 mg)

Experimental group

Treatment:

Drug: Dapagliflozin

Arm 5: Placebo matching Dapagliflozin

Experimental group

Treatment:

Drug: Placebo matching Dapagliflozin