BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes
NCT ID: NCT01498185
Last Updated: 2017-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
171 participants
INTERVENTIONAL
2012-02-29
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1: Dapagliflozin (1 mg)
Dapagliflozin
Tablets, Oral, 1 mg, Once daily, 14 days
Arm 2: Dapagliflozin (2.5 mg)
Dapagliflozin
Tablets, Oral, 1 mg, Once daily, 14 days
Arm 3: Dapagliflozin (5 mg)
Dapagliflozin
Tablets, Oral, 1 mg, Once daily, 14 days
Arm 4: Dapagliflozin (10 mg)
Dapagliflozin
Tablets, Oral, 1 mg, Once daily, 14 days
Arm 5: Placebo matching Dapagliflozin
Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, Once daily, 14 days
Interventions
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Dapagliflozin
Tablets, Oral, 1 mg, Once daily, 14 days
Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, Once daily, 14 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Astra Zeneca, Bristol-Myers Squibb
OTHER
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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References
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Melin J, Tang W, Rekic D, Hamren B, Penland RC, Boulton DW, Parkinson J. Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus. J Clin Pharmacol. 2022 Oct;62(10):1227-1235. doi: 10.1002/jcph.2062. Epub 2022 May 2.
Henry RR, Rosenstock J, Edelman S, Mudaliar S, Chalamandaris AG, Kasichayanula S, Bogle A, Iqbal N, List J, Griffen SC. Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study. Diabetes Care. 2015 Mar;38(3):412-9. doi: 10.2337/dc13-2955. Epub 2014 Sep 30.
Related Links
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MB102072\_Clinical\_Study\_Protocol
Other Identifiers
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MB102-072
Identifier Type: -
Identifier Source: org_study_id
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