A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00260156
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 1.6

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 effect of vildagliptin, an unapproved drug, on various measures of pancreatic islet function in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Clinical Study to Assess the Effect of Vildagliptin on Beta Cell Function in Drug Naive Patients With Type 2 Diabetes
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vildagliptin	Drug: vildagliptin
Placebo Comparator: Placebo	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. Change from baseline in hyperglycemia and arginine-stimulated first phase insulin secretion at 52 weeks [52 weeks]

Secondary Outcome Measures

1. Change from baseline in disposition index at 52 weeks [52 weeks]

2. Change from baseline in hyperglycemia and arginine stimulated second phase insulin secretion at 52 weeks [52 weeks]

3. Change in hyperglycemia-stimulated first phase insulin secretion at 52 weeks [52 weeks]

4. Change in hyperglycemia-stimulated second phase insulin secretion at 52 weeks [52 weeks]

5. Beta-cell function parameter derived from standard meal challenge [52 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Not currently on drug therapy for type 2 diabetes

• Blood glucose criteria must be met

Exclusion Criteria:

• History of type 1 diabetes

• Evidence of significant diabetic complications

• Serious cardiovascular events within the past 6 months

• Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 CLAF237A2381 on the Novartis clinical trials website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00260156
• Other Study ID Numbers: CLAF237A2381
• First Posted: Dec 1, 2005
• Last Update Posted: Dec 17, 2020
• Last Verified: Jan 1, 2013

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

Study Results

No Results Posted as of Dec 17, 2020