Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: Vildagliptin

• Registration Number: NCT00821977
• Lead Sponsor: Novartis

Brief Summary

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-05
• Disposition First Submitted: 2013-01-02
• Disposition First Submitted QC: 2013-01-02
• Disposition First Posted: 2013-01-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• Patients at least 18 years of age at Visit 1
• Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
• HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
• Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

Exclusion Criteria

• Pregnant or lactating female
• FPG ≥ 270 mg/dL (≥15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Vildagliptin Dose 1	Vildagliptin	-
Vildagliptin Dose 2	Vildagliptin	-

Primary Outcome Measures

Name	Time	Method
Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks.	24 weeks

Secondary Outcome Measures

Name	Time	Method
Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks	24 weeks
Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM	24 weeks
Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM	76 weeks
Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM	24 weeks

Trial Locations

Locations (170)

Advanced Clinical Research; 🇺🇸 Pell City, Alabama, United States

Horizon Clinical Research Associates, PLLC; 🇺🇸 Gilbert, Arizona, United States

Vista Medical Research, Inc; 🇺🇸 Mesa, Arizona, United States

Clinical Research Advantage; 🇺🇸 Mesa, Arizona, United States

Hope Clinical Research; 🇺🇸 Phoenix, Arizona, United States

Anasazi Internal Medicine; 🇺🇸 Phoenix, Arizona, United States

Tatum Ridge Internal Medicine; 🇺🇸 Phoenix, Arizona, United States

Paradigm Clinical; 🇺🇸 Tucson, Arizona, United States

Tucson Clinical Research; 🇺🇸 Tucson, Arizona, United States

Medical Investigations, Inc.; 🇺🇸 Little Rock, Arkansas, United States

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