Double Blind Placebo Study of Vildagliptin in Prehypertensives Type II Diabetics (Prediab) (PREDIAB)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Vasilios Kotsis, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01001962
First received: October 26, 2009
Last updated: February 2, 2014
Last verified: February 2014
  Purpose

Primary

  1. Reduction of 24h BP in type II diabetics with prehypertension in subjects receiving VILDAGLIPTIN
  2. Primary prevention of new onset of hypertension in subjects receiving VILDAGLIPTIN

Secondary

  1. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving VILDAGLIPTIN
  2. Reduction in the total cardiovascular risk in subjects receiving VILDAGLIPTIN.

Condition Intervention Phase
Hypertension
Type 2 Diabetes
Drug: Metformin
Drug: VILDAGLIPTIN
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Placebo Study of Vildagliptin in Prehypertensives Type II Diabetics

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Reduction of 24h BP in type II diabetics with prehypertension [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Primary prevention of new onset of hypertension [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Metformin
Treat with Metformin for type II diabetes for 4 weeks and then add placebo drug
Drug: Metformin
Treat with Metformin for type II diabetes for 4 weeks and then add placebo. Collected data: 24h SBP and DBP in time 0, 4, 12, 24 week.
Active Comparator: VILDAGLIPTIN
Treat with Metformin for type II diabetes for 4 weeks and then add VILDAGLIPTIN.
Drug: VILDAGLIPTIN
Treat with Metformin for type II diabetes for 4 weeks and then add VILDAGLIPTIN. Collected data: 24h SBP and DBP in time 0, 4, 12, 24 week.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 60 years.
  2. All patients are going to give their informed consent to participate in the study.
  3. Patients who are not receiving antihypertensive or diabetes treatment
  4. BP between 120 to 130 mmHg for systolic BP (prehypertensives)
  5. Type II diabetes (HbA1c 6.5-7.5)

Exclusion Criteria:

  1. Known oversensitiveness
  2. Chronic renal disease (GFR<50 ml/min) or ESRD
  3. Heart or respiratory failure
  4. Recent MI
  5. Shock
  6. Liver deficiency (ALT or AST >3 times normal
  7. Chronic alcohol use and pregnancy or lactation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001962

Locations
Greece
Hypertension 24h ABPM center Papageorgiou Hospital
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
  More Information

No publications provided

Responsible Party: Vasilios Kotsis, Prof. Med, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01001962     History of Changes
Other Study ID Numbers: PREDIAB
Study First Received: October 26, 2009
Last Updated: February 2, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:
VILDAGLIPTIN
blood pressure
hypertension in type II diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014