Overview

DPP-4 Inhibition, Incretins and Islet Function

Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
0
Participant gender:
All
Summary
Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lund University
Treatments:
Incretins
Saxagliptin
Sitagliptin Phosphate
Vildagliptin
Criteria
Inclusion Criteria:

- • Caucasian men or women with type 2 diabetes diagnosed according to ICD10 at time of
inclusion

- Ongoing treatment with life style adjustment including diet and exercise regimen
together with metformin as oral antidiabetic . Metformin therapy should be stable
the last three months

- Age 40-75 years

- HbA1c 52-80 mmol/mol (inclusive)

- BMI: 20-40 kg/m2

- Written informed consent has been given

- Capability and willingness to participate in the whole study

Exclusion Criteria:

- • Liver disease (K70-77 in ICD10) or liver enzymes three times above upper reference
range

- Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of
renal disease

- Proliferative diabetic retinopathy

- Treatment with any glucose-lowering medication except metformin

- Previous myocardial infarction, coronary heart disease or instable angina
pectoris in the last 6 months.

- Symptomatic heart failure (NYHA class II-III)

- Previous surgery on the gastrointestinal tract

- Larger surgical intervention during the last 12 weeks

- Female subject who are pregnant or breast feeding

- Women of child bearing potential not using a highly effective method of birth
control

- Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone

- Hypersensitivity to the active substances of to any of the excipients

- Participation in another study the last 4 weeks

- Smoker

- Paracetamol intolerance