Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00102466
• Collaborator: (none)
• Enrollment: 1,007
• Locations: 2
• Arms: 2
• Duration (Months): 48
• Patients Per Site: 503.5
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

This study is not being conducted in the United States. Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin; Drug: Gliclazide; Drug: Metformin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1007 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vildagliptin	Drug: vildagliptin; Drug: Metformin
Active Comparator: Gliclazide	Drug: Gliclazide; Drug: Metformin

Outcome Measures

Primary Outcome Measures

1. Change from baseline in HbA1c at 52 weeks [52 weeks]

Secondary Outcome Measures

1. Adverse event profile after 52 weeks of treatment [52 weeks]

2. Change from baseline in fasting plasma glucose at 52 weeks [52 weeks]

3. Patients with endpoint HbA1c <7% at 52 weeks [52 weeks]

4. Patients with reduction in HbA1c >/= 0.7% after 52 weeks [52 weeks]

5. Patients with reduction in HbA1c >/= 0.5% after 52 weeks [52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• On a stable dose of metformin as defined by the protocol

• Blood glucose criteria must be met

• Body mass index (BMI) in the range 22-45

Exclusion Criteria:

• Pregnancy or lactation

• Type 1 diabetes

• Evidence of significant diabetic complications

• Evidence of serious cardiovascular complications

• Laboratory value abnormalities as defined by the protocol

• Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Centers	Nurnberg		Germany
2	Novartis Pharmaceuticals	Basel		Switzerland

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for CLAF237A2338 from the Novartis Clinical Trials website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00102466
• Other Study ID Numbers: CLAF237A2338
• First Posted: Jan 31, 2005
• Last Update Posted: Dec 17, 2020
• Last Verified: May 1, 2017

• Keywords provided by Novartis Pharmaceuticals: type 2 diabetes; vildagliptin
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Vildagliptin; Gliclazide

Study Results

No Results Posted as of Dec 17, 2020