Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes, vildagliptin, metformin combination
Brief summary
This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.
Interventions
DRUGvildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Inclusion criteria
* Male, non-fertile female or female of childbearing potential using a medically approved birth control method * Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1 * Agreement to maintain the same dose of metformin throughout the study * Age in the range of 18-85 years inclusive. * HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1 * Agreement to maintain prior diet and exercise habits during the full course of the study * Ability to comply with all study requirements and signed informed consent to participate in the study.
Exclusion criteria
* Pregnant or lactating female A history of: * type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly. * acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months. Any of the following significant laboratory abnormalities: * ALT, AST greater than 2 times the upper limit of the normal range at visit 1. * Direct bilirubin greater than the upper limit of the normal range at visit 1. * Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit 1. * Clinically significant TSH values outside of normal range at visit 1. * Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucose | 24 weeks |
| Adverse event profiles including gastrointestinal tolerability and hypoglycemia | 24 weeks |
| Responder rates | 24 weeks |
| Change from baseline in insulin and proinsulin in a subgroup of patients | 24 weeks |
| Change in systolic and diastolic blood pressure | 24 weeks |
Countries
Germany
Outcome results
None listed