An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

Conditions

• Evaluate Ketogenic Stress

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Exenatide/Exenatide extended release — DRUG
  Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
• Dapagliflozin — DRUG
  Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
• Placebo — DRUG
  Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks

Study Details

The study investigations include evaluation of the acute effects of a single dose of dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or placebo under insulinopenic condition and the long term effect under basal conditions before and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and lipolysis.

Key Dates

Start date

Nov 1, 2016

Status verified

Feb 2024

Primary completion

Feb 1, 2021

Completion

Oct 24, 2021

Study Design

Enrollment

70 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Dapagliflozin Arm:
  dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
• Active Comparator: Exenatide extended release Arm:
  subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
• Placebo Comparator: Placebo Arm:
  dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
• Active Comparator: Exenatide extended release & dapagliflozin Arm:
  Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg

Primary Outcome Measure

Change in Beta-hydroxybutyrate Levels in Blood [ Time Frame: 12 weeks ]

Locations (1)

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