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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01498185
First received: December 21, 2011
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: Dapagliflozin
Drug: Placebo matching Dapagliflozin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Dapagliflozin (1 mg) Drug: Dapagliflozin
Tablets, Oral, 1 mg, Once daily, 14 days
Experimental: Arm 2: Dapagliflozin (2.5 mg) Drug: Dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 14 days
Experimental: Arm 3: Dapagliflozin (5 mg) Drug: Dapagliflozin
Tablets, Oral, 5 mg, Once daily, 14 days
Experimental: Arm 4: Dapagliflozin (10 mg) Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 14 days
Experimental: Arm 5: Placebo matching Dapagliflozin Drug: Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, Once daily, 14 days

Detailed Description:

Study Classification : Safety, Pharmacokinetics and Pharmacodynamics

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498185

Locations
United States, California
Profil Institute For Clinical Research, Inc.
Chula Vista, California, United States, 91911
Va San Diego Healthcare System
San Diego, California, United States, 92161
La Biomed Research Inst. At Harbor Ucla Med Ctr.
Torrance, California, United States, 90502
United States, Florida
Compass Research Phase 1, Llc
Orlando, Florida, United States, 32806
Progressive Medical Research
Port Orange, Florida, United States, 32127
United States, Kansas
Vince And Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Louisiana
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States, 70114
United States, Michigan
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States, 49007
United States, Missouri
Kansas City University Of Medicine And Biosciences
Kansas City, Missouri, United States, 64106
United States, South Dakota
Regional Medical Clinic-Endocrinology
Rapid City, South Dakota, United States, 57701
United States, Texas
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01498185     History of Changes
Other Study ID Numbers: MB102-072
Study First Received: December 21, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013