Long term effects of DPP-IV inhibitor treatment on the secretion and action of the incretin hormones in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002950-32-DK

Enrollment

Registered

2006-10-30

Start date

2006-11-23

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes diagnosed according to the criteria from WHO

Interventions

Product Name: Sitagliptin Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Type 2 diabetes diagnosed according to and in accordance with the WHO criteria • Metformin treatment of = 1 gram • 7,0 % = HbA1c = 10% • Age > 18 • BMI = 25 kg/m2 • Informed consent • Contraception, if appropriate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the effects of 3 months DPP-IV inhibitor treatment (Januvia®) on meal-induced secretion and insulinotropic effect of the incretin hormones, GLP-1 and GIP, on insulin sensitivity and on the ß-cell secretory capacity.;Secondary Objective: Examine the effects of 3 months DPP-IV inhibitor treatment on the potential DPP-IV substrates glucagon-like peptide 2 (GLP-2) and peptide-YY, on somatostatin and a further clarification of their role in the impaired incretin effect. Examine the effects of 3 months DPP-IV inhibitor treatment on glycaemic control parameters (HbA1c and fasting plasma glucose) ;Primary end point(s): Primary efficacy end point in trial part one is the relative increase in meal-induced total GLP-1 secretion after one and twelve weeks of Januvia® treatment in patients with type 2 diabetes. The primary secondary efficacy end points are an improvement in insulin sensitivity and ß-cell secretory capacity. In part two, the primary efficacy end point is the restoration of the insulinotropic effect of GIP, measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose, after 12 weeks of Januvia® treatment. In both part one and part two of the trial, secondary objectives will be an investigation of the treatment effect on the hormones glucagon, somatostatin and the potential DPP-IV substrates GLP-2 and peptide YY, as well as two glycaemic control parameters (HbA1c and fasting plasma glucose).	—

Measure

Time frame

Main Objective: Assess the effects of 3 months DPP-IV inhibitor treatment (Januvia®) on meal-induced secretion and insulinotropic effect of the incretin hormones, GLP-1 and GIP, on insulin sensitivity and on the ß-cell secretory capacity.;Secondary Objective: Examine the effects of 3 months DPP-IV inhibitor treatment on the potential DPP-IV substrates glucagon-like peptide 2 (GLP-2) and peptide-YY, on somatostatin and a further clarification of their role in the impaired incretin effect. Examine the effects of 3 months DPP-IV inhibitor treatment on glycaemic control parameters (HbA1c and fasting plasma glucose) ;Primary end point(s): Primary efficacy end point in trial part one is the relative increase in meal-induced total GLP-1 secretion after one and twelve weeks of Januvia® treatment in patients with type 2 diabetes. The primary secondary efficacy end points are an improvement in insulin sensitivity and ß-cell secretory capacity. In part two, the primary efficacy end point is the restoration of the insulinotropic effect of GIP, measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose, after 12 weeks of Januvia® treatment. In both part one and part two of the trial, secondary objectives will be an investigation of the treatment effect on the hormones glucagon, somatostatin and the potential DPP-IV substrates GLP-2 and peptide YY, as well as two glycaemic control parameters (HbA1c and fasting plasma glucose).

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026