Effect of adding vildagliptin to start of insulin treatment in patients with type 2 diabetes.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29400

Enrollment

Registered

2009-09-21

Start date

2009-11-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Diabetes

Interventions

Vildagliptin versus placebo, added to start of once daily insulin in combination with a standardized dose of metformin.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes; 2. Failing on oral agents; 3. BMI 25-35; 4. HbA1c 7.0-9.0 %; 5. Age 25-75 y.

Exclusion criteria

Exclusion criteria: 1. Pregnant women or women in the fertile period of life without adequate birth-control; 2. Type I DM, or secondary form of DM (eg pancreatic injury, prednisone induced); 3. Acute metabolic complications (severe hypoglycaemia, hospital-admission for uncontrolled Keto-acidosis) during the last 6 months; 4. Severe cardiac (LVEF 3 times elevated) or a history of hepatic failure, or renal impairment (creatinine clearance <50 ml/min).

Design outcomes

Primary

Measure	Time frame
Dose of insulin necessary for glycaemic control.	—

Secondary

Measure	Time frame
Hypoglycemia Weight Blood pressure Glycaemic variability Glucagon dynamics Lipids, markers of vascular function and inflammation and coagulation Skin autofluorescence (AGE-level)	—

Contacts

Public ContactW.L. Greven

Postbus 85500

w.l.greven@umcutrecht.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)