Clinical trial NCT00494884: Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
Official title: A Multicenter, Randomized, Double-blind, Parallel-group Study to Investigate the Glucose Lowering Effect, Safety and Tolerability of 24 Weeks Treatment With Vildagliptin 100 mg o.d. Versus Placebo Followed by a 12 Weeks Treatment Period With Open-label Vildagliptin 100 mg o.d. as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
metformin combination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-07-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose
timeFrame: 24 weeks
measure: Adverse event profiles including gastrointestinal tolerability and hypoglycemia
timeFrame: 24 weeks
measure: Responder rates
timeFrame: 24 weeks
measure: Change from baseline in insulin and proinsulin in a subgroup of patients
timeFrame: 24 weeks
measure: Change in systolic and diastolic blood pressure
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Ruhr-Universitat Bochum, Medizinische Klinik, St. Josef Hospital, Gudrunstr. 56, D-44791 Bochum, Telefon: 0234-509-2311, Telefax: 0234-509-2309
name: Prof. Dr. W. E. Schmidt
role: STUDY_DIRECTOR
References: