Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

NCT00494884 | Completed Phase 3

• 1 other identifier: CLAF237ADE02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes; vildagliptin; metformin combination

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c

  24 weeks

Secondary Outcomes (5)

• 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

Interventions

vildagliptin DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

Bochum, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Prof. Dr. W. E. Schmidt

  Ruhr-Universitat Bochum, Medizinische Klinik, St. Josef Hospital, Gudrunstr. 56, D-44791 Bochum, Telefon: 0234-509-2311, Telefax: 0234-509-2309

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 2, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

DE (1)