A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes

Sponsor
Uppsala University
Study ID
NCT02765204
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell glucagon release.

Key Dates

Start date
Mar 31, 2016
Status verified
Dec 2016
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: DS-D-DG
    The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
  • Experimental: DS-DG-D
    The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
  • Experimental: D-DG-DS
    The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
  • Experimental: D-DS-DG
    The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
  • Experimental: DG-D-DS
    The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
  • Experimental: DG-DS-D
    The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).

Primary Outcome Measure

Change in plasma glucagon levels from baseline to 0.5 hour after single-dose administration of drug. [ Time Frame: At start and 0.5 hour after the start of each intervention ]

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