Clinical Trials Logo
  1. Home
  2. Type 2 Diabetes
  3. NCT01159249
  4. Details
NCT01159249 Clinical Trial

Long-term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:
A Multicenter, Open Label, Long-Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01159249
Other study ID # CLAF237A1308
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2010
Est. completion date January 2012

Study information
Verified date May 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to demonstrate the long-term safety of vildagliptin in patients with type 2 diabetes. This study will study vildagliptin as add-on therapy with metformin, thiazolidinedione, α-glucosidase inhibitor (α-GI), rapid-acting insulin secretagogues in the treatment of type 2 diabetes in Japan.

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - patients with type 2 diabetes inadequately controlled with diet, exercise and metformin, thiazolidinedione, or a-GI, or glinides monotherapy - Age in the 20 years or over inclusive - HbA1c in the range of = 6.5 to = 10% Exclusion Criteria: - Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes - Significant heart diseases - Significant diabetic complications

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin

Locations
Country Name City State
Japan Novartis Investigative Site Chikushino Fukuoka
Japan Novartis Investigative Site Edogawa-ku Tokyo
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Fukuoka
Japan Novartis Investigative Site Hachioji Tokyo
Japan Novartis Investigative Site Hannou Saitama
Japan Novartis Investigative Site Hiki-Gun Saitama
Japan Novartis Investigative Site Hunabashi Chiba
Japan Novartis Investigative Site Itoshima-shi Fukuoka
Japan Novartis Investigative Site Izumisano Osaka
Japan Novartis Investigative Site Katsushika-ku Tokyo
Japan Novartis Investigative Site Kawaguchi Saitama
Japan Novartis Investigative Site Kawasaki Kanagawa
Japan Novartis Investigative Site Kawasaki Kanagawa
Japan Novartis Investigative Site Kobe Hyogo
Japan Novartis Investigative Site Koriyama Fukushima
Japan Novartis Investigative Site Koshigaya city Saitama
Japan Novartis Investigative Site Minato-ku Tokyo
Japan Novartis Investigative Site Shinagawa-ku Tokyo
Japan Novartis Investigative Site Tokorozawa Saitama
Japan Novartis Investigative Site Toshima-ku Tokyo
Japan Novartis Investigative Site Yokohama Kanagawa
Japan Novartis Investigative Site Yokohama-city Kanagawa

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure AEs, vital signs, laboratory evaluations 52 weeks
Secondary HBA1c 52 weeks
Secondary Fasting Plasma Glucose 52 weeks
Secondary Fasting Insulin 52 weeks
Secondary Fasting C-peptide 52 weeks
Secondary HOMA-B 52 weeks
See also
  Status Clinical Trial Phase
Completed NCT05219994 - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum N/A
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Completed NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Active, not recruiting NCT05566847 - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed NCT04965506 - A Study of IBI362 in Chinese Patients With Type 2 Diabetes Phase 2
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Active, not recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Completed NCT05378282 - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting NCT06010004 - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Phase 3
Completed NCT03653091 - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes N/A

External Links