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Completed

NCT Number: NCT02420392

Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell

To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta cell.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes for dapagliflozin arm
  • Normal glucose tolerance (fasting plasma glucose <100 mgd/l, HbA1c <6.0%) for normal glucose tolerance arm
  • Age 18 to 75 years
  • BMI <35 kg/m2
  • For type 2 diabetes patients, at least 3 months of treatment period and HbA1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea

Exclusion criteria

  • Who is allergic to dapagliflozin
  • Type 1 diabetes
  • Patients with history of diabetic ketoacidosis
  • Reduced renal function (eGFR <60ml/min/1.73m2)
  • Taking loop diuretics or dehydrated patient
  • History of hypotension when taking hypertensive medication
  • Diagnosed with heart failure
  • Diagnosed with cerebral infarction
  • Taking insulin, DPP-4 inhibitor, GLP-1 analogue, pioglitazone, alpha-glucosidase inhibitor
  • Above upper limit of normal hematocrit range (male 39-52%, female 36-48%)
  • Pregnant or breastfeeding women
  • History of recurrent genitourinary infection
  • AST/ALT more than two fold increased above normal upper limit
  • Hemolytic disorder

Treatment and study plan

Dapagliflozin

Drug

8 weeks treatment of dapagliflozin added to the type 2 diabetes patients with unsufficiently controlled with metformin or sulfonylurea

Primary outcomes

  1. Difference of incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion

    Time frame: From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp

    Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp

Secondary outcomes

  1. First phase insulin/C-peptide response

    Time frame: From 0 to 10 minutes of hyperglycemic clamp

  2. Second phase insulin/C-peptide response

    Time frame: From 10 to 60 minutes of hyperglycemic clamp

  3. Area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp

    Time frame: From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp

  4. Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp

    Time frame: From 120 minutes to 180 minutes during GIP infusion under hyperglycemic clamp

  5. Difference of incretin sensitivity between diabetes patients and normal glucose tolerance subjects

    Time frame: From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp

    Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp

  6. Difference of first phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects

    Time frame: From 0 to 10 minutes of hyperglycemic clamp

  7. Difference of second phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects

    Time frame: From 10 to 60 minutes of hyperglycemic clamp

  8. Difference of area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects

    Time frame: From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp

  9. Difference of Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects

    Time frame: From 120 minutes to 180 minutes during GIP infusion under hyperglycemic clamp

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • AstraZeneca

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2015
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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