Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in Patients With DM2.

Sponsor
University of Pisa
Study ID
NCT03714594
Phase
PHASE2
Status
Completed

Conditions

  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
35 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg — DRUG
    Dapagliflozin inhibits subtype 2 of the sodium-glucose transport proteins (SGLT2) which are responsible for at least 90% of the glucose reabsorption in the kidney. Blocking this transporter mechanism causes blood glucose to be eliminated through the urine.\[
  • Saxagliptin 5mg — DRUG
    Inhibits DPP-4 and slows inactivation of incretin hormones, thereby increasing blood concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus
  • Saxagliptin 5mg + Dapagliflozin 10 mg — DRUG
    Please see Intervention 1 and 2

Study Details

A phase IV, randomized, double-blind, single center pilot study in subjects with type 2 diabetes poorly controlled with metformin therapy will be randomized to receive, on top of metformin: saxagliptin (5 mg/day) and dapagliflozin (10 mg/day) (Group 1);saxagliptin (5 mg/day) and placebo (Group 2); dapagliflozin (10 mg/day) and placebo (Group 3) for 4 weeks.

Key Dates

Start date
Jul 24, 2018
Status verified
Nov 2022
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022

Study Design

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

Arms

  • Active Comparator: Dapagliflozin 10mg
    Dapagliflozin inhibits SGLT2 promoting the excretion of glucose in the urine,and lowers the plasma glucose concentration. This class of drugs has been shown to effectively reduce the HbA1c at all stages of T2DM and can be used in combination of all other anti-diabetic agents including insulin.
  • Active Comparator: Saxagliptin 5mg
    Saxagliptin is a DPP4 inhibitor.In patients with type 2 diabetes,administration of saxagliptin led to inhibition of DPP4 enzyme activity.After an oral glucose load,this DPP4 inhibition resulted in a increase in circulating levels of active incretin hormones include GLP-1 and GIP, decreased glucagon concentrations and increased glucose-dependent beta-cell responsiveness,which resulted in higher insulin and C-peptide concentrations.The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.
  • Active Comparator: Saxagliptin 5 mg + dapagliflozin 10 mg
    Please see Arm 1 and 2

Primary Outcome Measure

Glucose Metabolism [ Time Frame: from first day ]

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