Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

We wish to evaluate the effect of long term treatment with a DPP-IV inhibitor on the function of the incretin hormones

Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by DPP-IV inhibitor (Januvia®) treatment significantly ameliorates the impaired secretion and potency of GLP-1 and leads to a restoration of the lost action of GIP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Gastric Inhibitory Polypeptide; Incretins; Sitagliptin Phosphate

Criteria

Inclusion criteria

• Type 2 diabetes diagnosed according to and in accordance with the WHO criteria

• Metformin treatment of ≥ 1 gram

• 7,5 % ≤ HbA1c ≤ 10%

• Age > 18

• BMI ≥ 25 kg/m2

• Informed consent

• Contraception, if appropriate

Exclusion criteria

• Proliferating retinopathy

• Uremia, end stage renal disease, diabetic nephropathy or any other cause of impaired renal function with s-creatinine > 130 µM and/or albuminuria (>300 mg/day)

• Liver disease with ALAT and/or ASAT > 2 x normal value

• Complicated coronary artery disease, NYHA group III and IV

• Positive screening for islet cell auto antibodies and/or GAD-65 auto antibodies

• Occurrence of type 1 diabetes in first degree relatives

• Anaemia

• Pregnancy and/or breast feeding

• Treatment with medication affecting insulin secretion

• non-compliance

Withdrawal criteria

• The subject may withdraw at will at any time

• Pregnancy discovered during the trial

• Severe illness

• Unacceptable side effects

• If self-measured fasting plasma glucose on three consecutive days exceeds 15 mM, the result is repeated in an immediately scheduled visit, and no treatable intercurrent cause for the hyperglycaemia can be found.