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

NCT00106340 | Completed Phase 3

• 1 other identifier: CLAF237A2308
• Study Type: interventional
• Target: 3,118
• Locations: 2 countries
• Sites: 2

Brief Summary

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 long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetes; vildagliptin

Outcome Measures

Primary Outcomes (1)

• Time to HbA1c >8%

  2 year

Secondary Outcomes (5)

• Change from baseline in HbA1c at 5 years

  2 years (amended)

• Adverse event profile after 5 years of treatment

  2 years (amended)

• Coefficient of failure for HbA1c from week 24 to 5 years

  2 years (amended)

• Change from baseline in fasting plasma glucose at 5 years

  2 years (amended)

• Change from baseline in body weight at 5 years

  2 years (amended)

Study Arms (2)

Vildagliptin

EXPERIMENTAL

Drug: vildagliptin; Drug: Metformin; Drug: Glimepiride matching placebo

Glimepiride

ACTIVE COMPARATOR

Drug: glimepiride; Drug: Metformin; Drug: Vildagliptin matching placebo

Interventions

vildagliptin DRUG

Also known as: LAF237, Galvus

Vildagliptin

glimepiride DRUG

Glimepiride

Metformin DRUG

Glimepiride; Vildagliptin

Vildagliptin matching placebo DRUG

Glimepiride

Glimepiride matching placebo DRUG

Vildagliptin

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On a stable dose of metformin as defined by the protocol
• Body mass index (BMI) in the range 22-45
• Blood glucose criteria must be met

You may not qualify if:

• Pregnancy or lactation
• Type 1 diabetes
• Evidence of significant diabetic complications
• Evidence of serious cardiovascular complications
• Laboratory value abnormalities as defined by the protocol

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Investigative Centers

Nuremberg, Germany

Location

Related Links

• Results for CLAF237A2308 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin; 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine; glimepiride; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2005
• First Posted: March 23, 2005
• Study Start: March 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 20, 2008
• Last Updated: December 17, 2020

Record last verified: 2012-12

Locations

US (1); DE (1)