Vildalgliptin use in Type 2 Diabetes

Vildalgliptin and Glucose Variability in Type 2 Diabetes - Vildalgliptin study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006049-14-GB

Enrollment

Registered

2012-02-22

Start date

2012-05-18

Completion date

Unknown

Last updated

2014-06-30

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

Conditions

Diabetes and Cardiac risk benefit in South Asians. MedDRA version: 14.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Vildalgliptin Galvus Product Name: Vildalgliptin Pharmaceutical Form: Tablet INN or Proposed INN: metformin hydrochloride CAS Number: 657-24-9 Concentration unit: mg milligram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes of at least 6 months duration; HbA1c should be 7-9%. 2. Established on metformin and sulphonylurea combination therapy for at least 3 months 3. Body mass index from 25 kg/m2 to 45 kg/m2 4. Stable body weight (=65 years) yes F.1.3.1 Number of subjects for this age range 33

Exclusion criteria

Exclusion criteria: 1. Nursing mothers, pregnant women (excluded by a negative pregnancy test). 2. Patients with a history of drug/alcohol abuse 3. Abnormal liver function tests 4. Severe chronic renal failure (GFR<50 ml/min) or diabetic nephropathy 5. previous/ known hypersensivity to Vildalgliptin or any other substance in the study medic ation. 6. Failure to provide informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Patients will be given Vildagliptin 50mg daily and metformin or continue with their sulphonylurea and metformin algorithm to determine if Vildagliptin is effective in reducing cardiac risk profiles in South Asians. Patients diagnosed with Type II diabetes will be recruited into a 12-week, open labeled, randomized, case-controlled clinical study;Secondary Objective: The secondary outcome exploratory endpoints include cardiac autonomic function and continuous glucose monitoring testing and standardized quality of life measures. Safety measures will include glycosolated haemaglobin, lipid profiles, thyroid function tests, fasting glucose, liver function tests and full blood count. Further secondary measures include oxidative stress measurements.;Primary end point(s): We hypothesise that the enhanced cardiac risk in South Asians with T2DM reflects in part, increased glycaemic excursions and resultant periods of hypoglycaemia interspersed with episodes of oxidative stress. We also propose that vildagliptin by reducing glycaemic variability will decrease hypoglycaemia and reduce oxidative stress in diabetes to a greater extent than that achieved using sulphonylurea therapy. Ultimately we propose that this will translate into improved cardiovascular outcomes for South Asian patients with diabetes;Timepoint(s) of evaluation of this end point: 3months	—

Measure

Time frame

Main Objective: Patients will be given Vildagliptin 50mg daily and metformin or continue with their sulphonylurea and metformin algorithm to determine if Vildagliptin is effective in reducing cardiac risk profiles in South Asians. Patients diagnosed with Type II diabetes will be recruited into a 12-week, open labeled, randomized, case-controlled clinical study;Secondary Objective: The secondary outcome exploratory endpoints include cardiac autonomic function and continuous glucose monitoring testing and standardized quality of life measures. Safety measures will include glycosolated haemaglobin, lipid profiles, thyroid function tests, fasting glucose, liver function tests and full blood count. Further secondary measures include oxidative stress measurements.;Primary end point(s): We hypothesise that the enhanced cardiac risk in South Asians with T2DM reflects in part, increased glycaemic excursions and resultant periods of hypoglycaemia interspersed with episodes of oxidative stress. We also propose that vildagliptin by reducing glycaemic variability will decrease hypoglycaemia and reduce oxidative stress in diabetes to a greater extent than that achieved using sulphonylurea therapy. Ultimately we propose that this will translate into improved cardiovascular outcomes for South Asian patients with diabetes;Timepoint(s) of evaluation of this end point: 3months

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome measure is the difference in MAGE in the vildagliptin and sulphonylurea treated subjects;Timepoint(s) of evaluation of this end point: 3months	—

Countries

United Kingdom

Contacts

Public ContactKiran Dubb

The University of Birmingham

k.dubb@bham.ac.uk4401214143718

Outcome results

None listed

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