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

Part of paid clinical trials in Chula Vista, California.

Sponsor
AstraZeneca
Study ID
NCT01498185
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Feb 29, 2012
Status verified
Dec 2016
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
171 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Dapagliflozin (1 mg)
  • Experimental: Arm 2: Dapagliflozin (2.5 mg)
  • Experimental: Arm 3: Dapagliflozin (5 mg)
  • Experimental: Arm 4: Dapagliflozin (10 mg)
  • Experimental: Arm 5: Placebo matching Dapagliflozin

Primary Outcome Measure

Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7 [ Time Frame: From Baseline to Day 7 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Profil Institute For Clinical Research, Inc.Chula VistaCalifornia91911-
Va San Diego Healthcare SystemSan DiegoCalifornia92161-
La Biomed Research Inst. At Harbor Ucla Med Ctr.TorranceCalifornia90502-
Compass Research Phase 1, LlcOrlandoFlorida32806-
Progressive Medical ResearchPort OrangeFlorida32127-
Vince And Associates Clinical ResearchOverland ParkKansas66212-
Central Kentucky Research Associates, Inc.LexingtonKentucky40509-
Louisiana Research Associates, Inc.New OrleansLouisiana70114-
Jasper Clinic, Inc.KalamazooMichigan49007-
Kansas City University Of Medicine And BiosciencesKansas CityMissouri64106-
Regional Medical Clinic-EndocrinologyRapid CitySouth Dakota57701-
Dallas Diabetes & Endocrine CenterDallasTexas75230-

Find similar trials in Chula Vista, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Profil Institute For Clinical Research, Inc.· Chula Vista, CAVa San Diego Healthcare System· San Diego, CALa Biomed Research Inst. At Harbor Ucla Med Ctr.· Torrance, CACompass Research Phase 1, Llc· Orlando, FLProgressive Medical Research· Port Orange, FLVince And Associates Clinical Research· Overland Park, KS

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