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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01498185
First received: December 21, 2011
Last updated: June 6, 2014
Last verified: June 2014

December 21, 2011
June 6, 2014
February 2012
October 2012   (final data collection date for primary outcome measure)
  • Safety and tolerability of Dapagliflozin as measured by numbers of subjects with SAEs, deaths or discontinuations due to AEs, events of hypoglycemia, AEs of genitourinary infection or potentially clinically significant changes in vital signs [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    SAEs = Serious adverse events, AEs = Adverse events
  • Number of subjects with potentially clinically significant changes in vital signs (defined as marked abnormality) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of Dapagliflozin as measured by numbers of subjects with SAEs, deaths or discontinuations due to AEs, events of hypoglycemia, AEs of genitourinary infection or potentially clinically significant changes in vital signs [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    • SAEs - serious adverse events
    • AEs - adverse events
  • Number of subjects with potentially clinically significant changes in vital signs (defined as marked abnormality) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01498185 on ClinicalTrials.gov Archive Site
  • Change from baseline to day 7 in mean glucose based on 7-point central laboratory glucose [ Time Frame: Baseline (Day -1) and 7 days ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Dapagliflozin and its major inactive metabolite [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of Dapagliflozin and its major inactive metabolite [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Dapagliflozin and its major inactive metabolite [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Ratio of metabolite to parent area under the curve [AUC] (corrected for molecular weight) of Dapagliflozin and its major inactive metabolite [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Change from baseline to day 7 in mean glucose based on 7-point central laboratory glucose [ Time Frame: Baseline (Day -1) and 7 days ] [ Designated as safety issue: Yes ]
  • Maximum observed plasma concentration (Cmax) of Dapagliflozin and its major inactive metabolite [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Time of maximum observed plasma concentration (Tmax) of Dapagliflozin and its major inactive metabolite [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Dapagliflozin and its major inactive metabolite [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Ratio of metabolite to parent area under the curve [AUC] (corrected for molecular weight) of Dapagliflozin and its major inactive metabolite [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
A Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Explore the Safety, Pharmacokinetics and Pharmacodynamics of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus

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

Study Classification : Safety, Pharmacokinetics and Pharmacodynamics

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Drug: Dapagliflozin
    Tablets, Oral, 1 mg, Once daily, 14 days
  • Drug: Dapagliflozin
    Tablets, Oral, 2.5 mg, Once daily, 14 days
  • Drug: Dapagliflozin
    Tablets, Oral, 5 mg, Once daily, 14 days
  • Drug: Dapagliflozin
    Tablets, Oral, 10 mg, Once daily, 14 days
  • Drug: Placebo matching Dapagliflozin
    Tablets, Oral, 0 mg, Once daily, 14 days
  • Experimental: Arm 1: Dapagliflozin (1 mg)
    Intervention: Drug: Dapagliflozin
  • Experimental: Arm 2: Dapagliflozin (2.5 mg)
    Intervention: Drug: Dapagliflozin
  • Experimental: Arm 3: Dapagliflozin (5 mg)
    Intervention: Drug: Dapagliflozin
  • Experimental: Arm 4: Dapagliflozin (10 mg)
    Intervention: Drug: Dapagliflozin
  • Experimental: Arm 5: Placebo matching Dapagliflozin
    Intervention: Drug: Placebo matching Dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01498185
MB102-072
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP