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


- candidate number6504
- NTR NumberNTR2022
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-sep-2009
- Secondary IDsNL26046.041.09 METC UMC Utrecht
- Public TitleEffect of adding vildagliptin to start of insulin treatment in patients with type 2 diabetes.
- Scientific TitleEffect of adding vildagliptin to start of insulin treatment in patients with type 2 diabetes.
- ACRONYM
- hypothesisVildagliptin lowers insulin requirement, through effects on insulin and glucagon secretion.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus
- Inclusion criteria1. Type 2 diabetes;
2. Failing on oral agents;
3. BMI 25-35;
4. HbA1c 7.0-9.0 %;
5. Age 25-75 y.
- Exclusion criteria1. 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 < 30%) or hepatic (transaminases > 3 times elevated) or a history of hepatic failure, or renal impairment (creatinine clearance <50 ml/min).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2009
- planned closingdate1-dec-2010
- Target number of participants40
- InterventionsVildagliptin versus placebo, added to start of once daily insulin in combination with a standardized dose of metformin.
- Primary outcomeDose of insulin necessary for glycaemic control.
- Secondary outcomeHypoglycemia Weight Blood pressure Glycaemic variability Glucagon dynamics Lipids, markers of vascular function and inflammation and coagulation Skin autofluorescence (AGE-level)
- Timepoints0, 8, 16 weeks.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. W.L. Greven
- CONTACT for SCIENTIFIC QUERIESDrs. W.L. Greven
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Novartis
- PublicationsN/A
- Brief summaryType 2 diabetes is characterized by progressive beta cells, causing deterioration of beta cell function. Due to this progressive nature of the disease, at a certain point oral glucose lowering drugs in combination with diet cannot establish normoglycemia anymore. At this poit the patient should start insulin treatment. Usually once daily long-acting insulin is then started.
Insulin treatment usually results in weight gain and increases the change for hypoglycemia. A lot of research looks into the effect of oral glucose lowering drugs added to insulin on HbA1c, as a measure of glycemic regulation. Studies with DDP4-inhibitors showed, significant reduction of HbA1c , when added to insulin, where the insulin regimen was kept the same. This was seen in combination with less hypoglycemias. But in daily clinical practice insulin regimens will be modified according to glycemic variation, and not HbA1c but insulin doses are the primary effect. The mechanism of better glycemis control of combination of DPP4-inhibitors and insulin includes a glucose dependent insulin secretion (in contrast to for instance sulfonyl ureum derivates, which give a constant beta cel stimulation, unrelated to glucose) with the DPP4-inhibitors, as well as decreases in glucagon production (hyperglucagonemia is a problem in diabetes). Resulting in less endogeneous glucose production.
The primary effect of this study will be the necessary dose of insulin required. Secundary end points are parameters related to glucose regulation (continuous glucose measurement CGMS), insulin and glucagon levels after standardized mixed meal tests, vascular effects (24 hours blood pressure measurement, lipids), changes in advanced glycation end products (AGEs, measured by skin autofluorescence).
- Main changes (audit trail)
- RECORD21-sep-2009 - 19-mei-2012


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