Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00102388
• Collaborator: (none)
• Enrollment: 1,092
• Locations: 2
• Arms: 2
• Patients Per Site: 546

Study Details

Study Description

Brief Summary

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 1092 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vildagliptin	Drug: vildagliptin
Active Comparator: Gliclazide	Drug: Gliclazide

Outcome Measures

Primary Outcome Measures

1. Change from baseline in HbA1c at 104 weeks [104 weeks]

Secondary Outcome Measures

1. Adverse event profile at 104 weeks [104 weeks]

2. Change from baseline in fasting plasma glucose at 104 weeks [104 weeks]

3. Patients with endpoint HbA1c <7% after 104 weeks [104 weeks]

4. Patients with reduction in HbA1c >/= 0.7% after 104 weeks [104 weeks]

5. Patients with reduction in HbA1x >/= 0.5% after 104 weeks [104 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Not currently on drug therapy for type 2 diabetes

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

• Blood glucose criteria must be met

Exclusion Criteria:

• Pregnancy or lactation

• Type 1 diabetes

• Evidence of significant diabetic complications

• Evidence of serious cardiovascular conditions

• 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	Novartis Investigative Site	Investigative Centers		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

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00102388
• Other Study ID Numbers: CLAF237A2310
• First Posted: Jan 31, 2005
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

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

Study Results

No Results Posted as of Nov 18, 2016